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Global Congress on prostate cancer

Multiple mirrors for better management

First edition

For appropriate referencing to the abstracts, please use: Printed version: Mirrors of medicine Congress proceedings ISSN 2034-8393 1 Online version: Mirrors of medicine Congress proceedings ISSN 2034-8401


28-30 june 2012

3 days of focus on clinical decision making From diagnosis to managing advanced disease

Global Congress on prostate cancer Multiple mirrors for better management

abstracts reviewed by: guest editors Local organising committee of the congress Alex Mottrie, OLV Clinic, Aalst, Belgium Bertrand Tombal, University Hospital Saint-Luc, Brussels, Belgium Hein Van Poppel, University Hospitals Leuven, Leuven, Belgium Gert De Meerleer, Ghent University Hospital, Ghent, Belgium

Scientific committee of the congress Jelle Barentsz, University Medical Center Nijmegen, The Netherlands Joaquim Bellmunt, University Hospital del Mar, Barcelona, Spain Alberto Bossi, Gustave Roussy Institute, Villejuif, France Vincenzo Ficarra, OLV Robotic Surgery Institute, Aalst, Belgium Markus Graefen, University of Hamburg, Hamburg, Germany Axel Heidenreich, University Hospital Aachen, Aachen, Germany Francesco Montorsi, Vita-Salute San Raffaele University, Milan, Italy Peter Wiklund, Karolinska Hospital Urological Clinic, Stockholm, Sweden

published by: e-HIMS Duwijckstraat 17 2500 Lier, Belgium F: +32 3 491 82 71

This publication is supported by an unrestricted grant of Bayer Healthcare.


Abstracts of the Global Congress on Prostate Cancer, 1st edition Brussels, Belgium, 28-30 June 2012

Table of contents Abstracts accepted for oral presentation main session . . . . . . . . . . . . . . . . . . . 1-2 Abstracts accepted for oral presentation poster session. . . . . . . . . . . . . . . . . 3-17 Abstracts accepted for poster presentation . . . . . . . . . . . . . . . . . . . . . . . . . . 17-44

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Abstracts accepted for oral presentation main session

MDV3100

The 4 winning abstracts are presented on Saturday at 12.00 during the main session in Auditorium 1. For detailed programme see live screens or http://live.prosca.org

1 Primary, secondary, and quality-of-life endpoint results from the Phase 3 AFFIRM study of MDV3100, an androgen receptor signaling inhibitor Sternberg CN1, Scher HI2, Fizazi K3, Saad F4, Taplin ME5, Miller K6, Mulders PFA7, Chi KN8, Armstrong AJ9, Hirmand M10, Selby S11, de Bono JS12, for the AFFIRM Investigators. 1 Department of Medical Oncology, San Camillo Forlanini Hospital, Rome, Italy; 2Sidney Kimmel Center for Urologic and Prostate Cancers, Memorial Sloan-Kettering Cancer Center, New York, NY, United States; 3Department of Cancer Medicine, University of Paris Sud, Villejuif, France; 4University of Montreal Hospital Center, University of Montreal, Montreal, QC, Canada; 5Genitourinary Cancer Treatment Center, DanaFarber Cancer Institute, Boston, MA, United States; 6Department of Urology, Charité - Universitätsmedizin Berlin, Berlin, Germany; 7Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands; 8Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, British Columbia, Canada; 9 Department of Medicine, Duke University, Durham, NC, United States; 10Clinical Development, Medivation, Inc., San Francisco, CA, United States; 11Department of Biometrics, Medivation, Inc., San Francisco, CA, United States; 12Drug Development Unit, Institute of Cancer Research, London, United Kingdom

Placebo

HR (95% P-value CI) <0.0001

25.1%+3.8% 2.9%+1.0%

0.631 (0.529, 0.752) 0.404 (0.350, 0.466) 0.248 (0.204, 0.303) -

54.0%

1.5%

-

<0.0001

43.3%

17.8%

-

<0.0001

OS, median

18.4 months 13.6 months

rPFS, median

8.3 months

2.9 months

TTPP, median

8.3 months

3.0 months

PR+CR PSA response QoL response

<0.0001

<0.0001

<0.0001

The most common MDV3100 adverse events with incidences higher than placebo were fatigue (34% vs 29%), diarrhea (21% vs 18%), and hot flush (20% vs 10%). Grade >3 events of interest were cardiac disorders (0.9% MDV3100 vs 2% placebo), fatigue (6% MDV3100 vs 7% placebo), seizure (0.6% MDV3100 vs 0% placebo), and LFT abnormalities (0.4% MDV3100 vs 0.8% placebo). Conclusions: MDV3100, a novel ARSI, is generally well-tolerated and significantly prolongs OS, slows disease progression, and improves QoL in men with mCRPC post-docetaxel.

Background: MDV3100, a novel androgen receptor (AR) signaling inhibitor (ARSI), inhibits: 1) binding of androgens to AR, 2) AR nuclear translocation, and 3) association of AR with DNA. MDV3100 was active in a phase 1-2 trial enrolling pre- and post-docetaxel castration-resistant prostate cancer (CRPC) patients. The AFFIRM trial evaluated whether MDV3100 could provide benefit to men with post-docetaxel metastatic CRPC (mCRPC).

2 Radium-223 chloride (Ra-223), a first-in-class alphaemitter: product profile and clinical experience in patients with castration-resistant prostate cancer (CRPC) and bone metastases Nilsson S1, Parker C2, Biggin C3, Staudacher K3, Aksnes AK3, Zou J4, Bruland ØS5. 1 Radiumhemmet, Karolinska University Hospital, Stockholm, Sweden; 2Radiotherapy, The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom; 3Algeta ASA, Oslo, Norway; 4Bayer HealthCare Pharmaceuticals, Montville, NJ, United States; 5 Oncology, Norwegian Radium Hospital, University of Oslo, Oslo, Norway

Methods: In this double-blind, multinational phase 3 study, mCRPC patients who had received 1-2 lines of therapy, including prior docetaxel-based chemotherapy were randomized 2:1 to MDV3100 160 mg/day or placebo. Treatment with corticosteroids was not required but allowed. Patient randomization was stratified by baseline ECOG and mean brief pain inventory score. The primary endpoint was overall survival (OS). Other efficacy endpoints included radiographic progression-free survival (rPFS), time to PSA progression (TTPP), soft tissue objective response (PR+CR), PSA response (>50% decrease), and quality-of-life (QoL) response (>10 point improvement in FACT-P global score).

Introduction: Ra-223 is a first-in-class alpha-emitter with a potent, targeted, antitumor effect on bone metastases and a favorable safety profile. High-energy alpha-radiation induces double-strand DNA breaks, causing highly localized cytotoxicity in metastatic cancer cells, sparing other healthy tissue and bone marrow. Product profile and clinical experience from phase I, II, and III studies are described. Methods: Radiation properties of Ra-223 allow for its safe use. Two open-label phase I trials (n=37) and 3 double-blind phase II trials (n=255) assessed Ra-223 dosimetry, safety, and efficacy. Single intravenous doses ranged from 5 to 250 kBq/kg b.w.; repeated dosage regimens varied. Clinical efficacy and safety were assessed in a multinational, randomized, double-blind phase III trial (ALSYMPCA) in 921 CRPC patients with bone metastases receiving 6 injections of Ra-223 50 kBq/kg b.w. every 4 weeks plus best standard of care (BSC).

Results: 800 patients were randomized to MDV3100 and 399 to placebo with respective median treatment durations of 8.3 and 3.0 months. The treatment groups were well-balanced with a significant proportion of patients having >20 bone lesions (37.8% MDV3100 vs 37.8% placebo) or visceral liver/lung lesions (24.5% MDV3100 vs 20.6% placebo). Efficacy results are presented (Table).

Results: The 11.4-day physical half-life of Ra-223 facilitated its preparation, distribution, and administration with minimal shielding requirements. The ultra-short penetration of alphaparticles permits easy handling of Ra-223 and repeated injections. Treatment was delivered on an outpatient basis with 1


minimal radiation protection restrictions after treatment. As there is a small component of gamma-radiation with Ra-223 decay, standard contamination monitoring equipment can be used.

in the E-PLND and in 8 (10.8%) patients in the SE-PLND group. Cumulative 3-year PFS rate was 64.6±10.1% for patients in the S-PLND group, 84.4±7.7% in the E-PLND group and 81.49±9.9% in the SE-PLND group (p=0.035). More extended PLND with removing >20 LN was associated with significantly increasing PFS rates. Comparing cumulative 38-month PFS in subgroup of patients with ≤10 and >20 LN removed, PFS rates were 36.9% and 76.5% respectively (p=0.003).

In the phase II placebo-controlled study in 64 patients receiving BSC plus either Ra-223 or placebo, median survival increased by 4.5 months (P=0.017), serum bone alkaline phosphatase decreased significantly, and time to prostate-specific antigen progression was significantly prolonged with Ra-223. These findings are consistent with the clinical benefit reported in the interim analysis of 809 patients in the ALSYMPCA trial (median overall survival: 14.0 months for Ra-223 vs 11.2 months for placebo [2-sided P=0.00185; HR=0.695; 95% CI: 0.552, 0.875]).

Conclusions: E-PLND and SE-PLND are more accurate for LN staging in PC patients. S-PLND is associated with worse survival and should not be performed in cases of intermediate and high risk PC. Extensive E-PLND and SE-PLND with removing >20 LN could be recommended in this group of patients to achieve better PFS.

Ra-223 had a favorable safety profile across these trials. In ALSYMPCA, there was a low incidence of myelosuppression with Ra-223 (grade 3/4 neutropenia: 1.8% vs 0.8% in Ra-223 and placebo groups, respectively).

4

Conclusions: Ra-223 shows a survival benefit and a favorable safety profile in CRPC patients with bone metastases. Ra-223 is easy to use, and few radiation restrictions are required.

Results of pathohistological examination in clinically high-risk prostate cancer patients undergoing radical prostatectomy Musch M1, Roggenbuck U1, Plümmer J2, Klevecka V2, Kröpfl D2. 1Institute of Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany; 2Department of Urology, Paediatric Urology and Urological Oncology, Kliniken Essen-Mitte, Essen, Germany

3 Extension of lymph node dissection can increase progressionfree survival in patients with intermediate and high risk prostate cancer

Objectives: We analyzed the results of pathohistological examination in patients with clinically high-risk prostate cancer (PCA) following radical prostatectomy to determine the proportion of patients eventually presenting overall favorable tumor characteristics (OFTC) (i.e. pT2a-c and Gleason score ≤7a and pN0).

Andrianov AN, Alekseev BY, Nyushko KM, Vorobyev NV. Urology, Moscow Hertzen Oncology Institute, Moscow, Russian Federation

Methods: Between 01/06/1997 and 31/10/2011 2346 patients with biopsy detected PCA underwent radical prostatectomy in our institution. According to D’Amico criteria 1767 patients presented low- (n=962) or intermediate-risk (n=805), and 579 high-risk PCA. The pathohistological findings of the prostatectomy specimens were compared between low-/ intermediate-risk versus high-risk patients, and between patients with different high-risk factor constellations.

Introduction & Objectives: Recent clinical data have established that standard pelvic lymph node dissection (S-PLND) in prostate cancer (PC) patients is less accurate in assessing lymph node (LN) metastases than extended (E-PLND). Several studies have demonstrated that E-PLND could enhance survival, although this question is on the debate because of absence of data of randomized studies. The aim of the study was to evaluate biochemical progression-free survival (PFS) in intermediate and high risk PC patients who had undergone radical prostatectomy (RPE) and PLND.

Results: High-risk PCA patients showed significantly more nonorgan-confined PCA (74.8% vs. 36.6%; p<0.0001), prostatectomy Gleason scores ≥7b (53.0% vs. 13.8%; p<0.0001), lymph node metastases (28.7% vs. 4.9%; p<0.0001), and positive surgical margins (50.2% vs. 27.3%; p<0.0001) when compared to low-/ intermediate-risk PCA patients. Accordingly, high-risk patients were less likely to harbor OFTC (17.3% vs. 58.2%; p<0.0001). Conversely, that means, however, that nearly every 5th patient assumed to be at high risk of disease progression following radical prostatectomy indeed has favorable and most likely curable PCA. Especially the subgroup of patients with PSA >20 ng/ml or cT2c-3 tumor as sole high-risk factor showed a considerable proportion of OFTC in 30.2% and 26.1% of cases, respectively. Contrary, patients with biopsy Gleason scores 8-10 as sole high-risk factor were associated with OFTC in only 8.6% of cases. Thus, the latter patients had a likewise low rate of OFTC as had patients with two (3.7-8.0%) or three high-risk factors (3.4%).

Materials & Methods: Retrospective analysis of a database from 595 patients after RPE and PLND since 2006 till 2011 in our institution was performed. 288 consecutive patients with intermediate and high risk PC (PSA >10 ng/ml, clinical stage ≥T2b, biopsy Gleason score ≥7, percentage of positive biopsy cores ≥50%) were included for analysis. According to anatomical regions of PLND performed, patients were divided into 3 groups: S-PLND was performed in 39 (13.5%) patients; E-PLND – in 137 (47.6%) and super extended PLND (SE-PLND) – in 112 (38.9%) patients. LN metastases were verified in 2 (5.1%), 26 (18.9%) and 38 (33.9%) patients respectively (p=0.003). Patients with LN metastases were excluded from the further survival analysis. Mean number of LN removed was 13.6±6.9 (4-31); 23.3±7.2 (12-56) and 29.1±7.9 (15-52) respectively (p<0.0001); mean PSA level was 11.1±5.6 ng/ml; 13.7±9.3 ng/ml and 16.4±10.6 ng/ ml respectively (p=0.04); mean percentage of positive biopsy cores was 43.4±27.5%; 47.2±23.9% and 55.2±27.3% respectively (p=0.05). Biopsy Gleason score was significantly more favorable in the S-PLND group of patients (p=0.0002). Biochemical recurrence was assessed as elevation of PSA >0.2 ng/ml on 3 consecutive measurements.

Conclusions: Nearly every 5th patient assumed to be clinically at high risk of PCA progression following radical prostatectomy indeed had OFTC. Particularly patients with PSA >20 ng/ml or cT2c-3 tumor as sole high-risk factor were misclassified.

Results: Median follow up time was 25 months (3-72 months). During this period biochemical recurrences were observed in 10 (27%) patients in the S-PLND group, in 13 (11.7%) patients 2


Abstracts accepted for oral presentation poster session

Minor postoperative complications Urinary tract infection

N=140 (4%)

Re-cystogram (extravasation)

N=110 (3.1%)

Retention after catheter removal

N=46 (1.31%)

Abdominal pain

N=32 (1%)

Fever

N=20 (0.6%)

Solder pain

N=18 (0.6%)

Constipation

N=17 (0.6%)

Perivesical hematoma

N=15 (0.5%)

5

Asymptomatic lymphocele

N=12 (0.4%)

Scrotal edema

N=10 (0.3%)

Intraoperative and postoperative complications encountered in patients undergoing robotic-assisted laparoscopic radical prostatectomy. An analysis of 3500 consecutive cases

Bladder coagel evacuation

N=9 (0.3%)

Allergy

N=9 (0.3%)

Bladder tenismus

N=9 (0.3%)

Arrhythmia

N=8 (0.2%)

Scrotal hematoma

N=6 (0.2%)

Penis edema

N=6 (0.2%)

Port site infection

N=6 (0.2%)

Acute epididymitis

N=6 (0.2%)

Subcutaneous emphysema

N=6 (0.2%)

Materials & Methods: The records of N=3500 men who underwent RALP from February 2006 to February 2012 were retrospectively reviewed. All patients were assessed for intraoperative as well as postoperative complications. Postoperative complications and re-interventions encountered up to 30 days postoperatively stratified by the Clavien classification and were characterized as minor (Clavien’s grade I–IIIa) and major postoperative complications (Clavien’s grade IIIb-IVa). Hemorrhage was defined as greater than 500 ml blood loss during the operation. Further parameters analyzed included: age, body mass index (BMI), prostate size, PSA values, biopsy Gleason score, lymph node dissection, and pathologic stage.

Hypotension

N=5 (0.1%)

Conjunctivitis

N=5 (0.1%)

Results: The intraoperative complications as well as minor and major postoperative complications are listed in the Tables. The median age of the patients was 64.2 years, median BMI was 26.6 kg/m2, median prostate weight was 41.3 gr. and median PSA value was 10.1 ng/ml. The Gleason biopsy score was Gleason <7 in 65% of cases, Gleason 7 in 34.6% and Gleason >7 in 9.4% of cases. Lymph node dissection was performed in 75.6% of cases. An organconfined disease was noted in 75.2% of cases and extraprostatic extension in 24.8%. The overall intraoperative complication rate was 4.9%, the overall minor postoperative complication rate was 16.1% and the overall major postoperative complication rate was 1.8%.

6

Conclusions: RALP is not free of complications. Nevertheless in experienced hands it can be considered as a safe surgical procedure with very low morbidity and mortality.

10 years experience: permanent prostate implant (PPI) and iodine 125 (I125) seeds

Moderated poster sessions will take place in Auditorium 3 and in meeting room 4 at the Riverside wing during the lunch breaks on Thursday and Friday, For detailed programme see live screens or http://live.prosca.org

Labanaris AP, Zugor V, Wagner C, Witt JH. Urology, Prostate Center Northwest, St. Antonius-Hospital, Gronau, Germany Objectives: To assess the intraoperative and postoperative complications encountered in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP) by analysing 3500 consecutive cases.

Major postoperative complications

N=65 (1.85%)

Hemorrhage

N=44 (1.4%)

Technical problems of the system

N=10 (0.3%)

Tearing of the anastomosis suture

N=10 (0.3%)

Small intestine injury

N=8 (0.2%)

Rectum injury

N=7 (0.2%)

Bladder perforation

N=7 (0.2%)

Large intestine injury

N=5 (0.1%)

Tearing of the anastomosis

N=5 (0.1%)

Defect robot arm

N=5 (0.1%)

Ureter injury

N=1 (0.03%)

Obturator nerve injury

N=1 (0.03%)

N=46 (1.31%) N=18 (0.51%) N=7 (0.2%)

Abscess Port site hernia (0.2%) Windowing of lymphocele Dehiscence of the fascia with closure Nephrostomy

N=4 (0.1%) N=6 (0.2%) N=4 (0.1%) N=4 (0.1%) N=2 (0.05%)

Secondary rupture of the anastomosis

N=18 (0.51%)

Acute renal failure

N=3 (0.1%)

Adult respiratory distress syndrome

N=2 (0.05%)

Stroke

N=2 (0.05%)

Myocardial Infarct

N=2 (0.05%)

Cardiac arrest

N=1 (0.03%)

Burette R1, Bourgois N1, Corbusier A 2, Germeau F2, Hamal M1,3, Audia S1,3, Van Leer P2. 1 Radiotherapy, CHIREC, Brussels, Belgium; 2Urology, CHIREC, Brussels, Belgium; 3 Physics, CHIREC, Brussels, Belgium

Intraoperative complications Anastomosis insufficiency

Re-operations (Overall) Hematoma Intestine lesions

Purpose: Since 2000, we prospectively record our experience with I125 seeds PPI Mt Sinaï Real-Time° method proctoring as these were available in Europe. The aim of this study is to report the clinical results, benefit and side effects, the progresses made in the technology of various types of I125 seeds retrospectively compared still using Real-Time° method. Dose constraints aimed at increasing V100p D90p and reducing V150p D30u. Better CTV coverage and OAR shielding were to enhance disease control and decrease urinary and sexual dysfunction. Materials & Methods: From September 2000, 512 low-risk and intermediate-risks patients were treated by PPI in various institutions. 408 home patients were followed and 391 (95.8%) 3


were evaluable for bFFF survival (PSA <1 ng/ml). For some patients, QoL through IPSS score, QLQ-C30, CTAC AE were retrospectively analyzed at 1 year. Dosimetrical optimized data were correlated with clinical evolution. ABS-ESTRO recommendations were matched pre and post operatively by a US-CT scan at 1 month, some cases at 3-6 months. Migration of seeds was tracked by seed finder fusion software at the same time in order to quantify contributions to dose constrains with these different seeds.

Coli was isolated in 19/22 cases. No organism was isolated in 3/22 cases. 58% of isolates were ciprofloxacin resistant, 36% gentamicin resistant and 10% augmentin resistant. No isolates were meropenem resistant. No ESBL activity was identified. Augmentin and gentamicin would have covered 90% of E.Coli identified. Statistical analysis noted a marginally significant increase in sepsis rates over time. The significance of this is unclear. Discussion: Only E. Coli was identified as the cause of sepsis. Isolates were often but not always ciprofloxacin resistant. One in 3 isolates were resistant to gentamicin. Screening for ciprofloxacin resistance in rectal flora may therefore reduce some of the septic episodes but not all. It is still unclear after analysing 6 years of biopsy data whether the sepsis rate is increasing. This reflects the relatively rare nature of the event. No obvious underlying risk factors were identified.

Results: Improvement of V100p from a mean of 95% to more than 98% confirmed better post planning dose coverage of prostate CTV volume significantly due to more peripheral implantation of seeds. All the patients had a minimum D90p of more than 155 Gy with a mean of 175.3 Gy. Reduction of V150p from a mean of 65% to 52 % as D30u from a mean 195 Gy to less than 175 Gy (11%) was also correlated with additional effect of more peripheral positioning and reduction of seeds migrations in the central area.

Conclusions: Ciprofloxacin prophylaxis remains an appropriate regime for prostate biopsy. Evidence of an increasing rate over time of sepsis post TRUS guided prostate biopsy may have been identified. An empirical antibiotic choice of gentamicin and augmentin would have covered 18/19 and meropenem all identified E.Coli causes of septicaemia.

Rectal wall sparing was confirmed by V100r systematically inferior to 1.30 cc with a mean of 0.80 cc and was never a clinical problem. Contribution of new coated seeds to migration reduction is under investigation on quality of implant compared to historical technique. With a mean follow-up of 86.4 months, 8 patients died and only 2 from PCa (2.05%). 26 biological recurrences (6.65%) were analysed out of which 20 were GS VII with a bFFF of 93.35%. Recurrences were mainly localized in lymphatic nodes combined or not with metastasis. 7 patients experienced secondary cancers; 20 cardiovascular diseases.

8 A decade of high intensity focused ultrasound in prostate cancer, long-term oncologic results: a single centre experience

Conclusions: In this retrospective 10-years study, we can confirm, like other teams, that PPI in PCa is a highly effective treatment. Technology enhancements in seeds development and positioning is giving a clear geometrical and technical clinical impact to patient’s disease control and reduction of side effects. PPI is a good option in selected indications for favorable- or intermediate-risk prostate cancers associated with maintenance of a good urinary and erectile function.

Holz S, Limani K, Peltier A, Hawaux E, van Velthoven R. Urology, Institut Jules Bordet, Bruxelles, Belgium Introduction: The management of localized prostate cancer is evolving and controversial. Established treatment options include radical prostatectomy, radiation therapy and active surveillance. These treatments may induce complications or emphasize patient’s anxiety; therefore minimally-invasive alternative treatments are emerging. High intensity focused ultrasound (HIFU) is an emerging alternative to established standard of care, especially in heavily comorbid and elderly patients.

7 Septicaemia after transrectal biopsy of the prostate: a 6-year analysis of 2400 biopsies

Methods: We retrospectively evaluated all patients treated with global HIFU as primary curative therapy for prostate cancer in our institution, including those who have received neo-adjuvant hormone therapy. From September 2001 to December 2010 a total of 100 patients were treated with global HIFU. We excluded patients with follow-up inferior to 1 year (4 patients) and patients with incomplete oncologic data (5 patients). 91 patients were included for statistical analysis. Evaluated end points were; overall, cancer-specific and metastasis-free survival as well as biochemical recurrence-free survival using Astro Phoenix definition (PSA nadir + 2.0 ng/mL) and Stuttgart definition (PSA nadir + 1.2 ng/mL).

Holmes MA, Bary P, Smit-Archer L, Devcich G, Leyland J. Urology, Waikato Hospital, Hamilton, New Zealand Introduction & Objectives: All patients who underwent a transrectal ultrasound guided (TRUS) prostate biopsy between 2006 and 2011 under local anaesthetic were reviewed to assess the annual sepsis rate, causative organisms, antibiotic sensitivities, identify any obvious possible pre-existing risk factors and confirm an appropriate empirical antibiotic regime for post TRUS prostate septicaemia.

Results: Median age was 75 years (range: 61-87). Gleason biopsy distribution was: 66% less than 7, 24% of 7 and 10% higher than 7. Mean and median PSA were: 11.32 +/- 9.94 ng/mL and 8.37 respectively. T-stage: 51% T1, 45% T2, 4% T3. D’Amico risk stratification: 34% low, 46% intermediate and 20% high. Median actuarial follow-up was 7.25 years. At 5 and 10 years the estimated median survival was: overall 89%-66%, cancer-specific 96%-84%, metastasis-free 85%-65%, biochemical recurrencefree, Phoenix: 53%-34% and Stuttgart: 52%-29%. Statistically significant univariate prognostic factors for biochemical recurrence were: D’Amico high risk (p<0.05), pre-HIFU PSA (p<0.0001) and PSA at nadir (p<0.0001).

Patients & Methods: All hospital admissions for urosepsis occur at 1 large regional hospital. Draining secondary hospitals share a common database. A single private lab is the sole provider of pathology services to the region. 12 core prostate biopsies, without an enema, are performed under a standard ciprofloxacin prophylaxis regime. Admissions were identified by 3 mechanisms including an individual review of each patient’s pathology and hospital data around the time of their biopsy. Interim results for 2007-2010 have been previously published. Results: 2513 patients underwent a TRUS of the prostate. 2337 patients had a TRUS guided biopsy. 22 patients were admitted with urosepsis (0.94%). Sepsis rates were 0.3% in 2006 and 2007, 1.1% in 2008, 1.2% in 2009, 0.8% in 2010 and 1.8% in 2011. E. 4


Discussion: HIFU remains a controversial treatment for prostate cancer. In our series, high-risk patients performed very poorly. Candidates for HIFU should be very carefully selected. PSA at nadir seems to be a valid prognostic factor for biochemical recurrence.

Introduction: Achieving clear margins in robotic prostatectomy is expected to improve oncological outcomes. We looked at the impact of focal (fPSM: single and <5mm) and extensive positive margins (ePSM: multiple or ≥5mm) and attempted to identify predictive factors. Patients & Methods: Prospective data collection enabled the identification of an intermediate risk group (any Gleason 7 or PSA 10-20 or pT2b or T2c) for analysis. Low risk category patients (Gleason ≤6 & PSA <10 & T2a) were excluded as all had clear margins and successful outcome. Mean follow up was 14.72 months (6-40). End points were defined as surgical success (PSA ≤0.1); surgical failure (PSA >0.1) and adjuvant radiotherapy. We compared the PSM group to 49 case-matched patients with negative surgical margins (NSM).

9 Positive surgical margin rates in patients undergoing bilateral intrafacial nerve sparing robot-assisted laparoscopic radical prostatectomy Labanaris AP, Zugor V, Wagner C, Habibzada J, Witt JH. Urology, Prostate Center Northwest, St. Antonius-Hospital, Gronau, Germany

Results: 44 patients had positive surgical margins (PSM). There was no significant difference in PSA (p=0.9997) and Gleason score (p=0.9960) in the PSM and NSM groups.

Objectives: Although the past years robot-assisted laparoscopic radical prostatectomy (RALP) has become profoundly popular, especially due to the ability to preserve the neurovascular bundles, some urologists remain sceptic regarding the lack of tactile sensation and subsequently a possible increase of positive surgical margins (PSM). The objective of this study is to evaluate the PSM rates in patients undergoing bilateral intrafacial nerve sparing (BINS) RALP prostatectomy.

Surgical failure was seen in 4% of NSM and 18% of all PSM (p=0.04). However, on sub-group analysis of PSM the surgical failure rate was 8% of fPSM (p=0.49) and 22% of ePSM (p=0.022). There was a significant difference in cancer volume between NSM and all PSM (p=0.0002), fPSM (p=0.0225) and ePSM (p<0.0001). There was also a significant difference in prostate size between NSM and fPSM (p=0.0409).

Materials & Methods: The records of N=621 men who underwent BINS RALP from February 2006 to August 2011 were retrospectively reviewed. None of the patients had undergone any form of adjuvant therapy that would have influenced the surgical margin status such as previous hormonal therapy, external radiation, brachytherapy and HIFU therapy. Additionally all stage T0 cancer patients were excluded from the study. The parameters analysed included: age, prostate specific antigen (PSA), prostate size, clinical stage, preoperative Gleason score, pathologic stage, postoperative Gleason score, percent of tumor, overall PSM rates and PSM rates according to pathologic stage. BINS was performed in patients with a PSA level <10 ng/ml and/or Gleason score <7 and/or in cases of only one positive core biopsy of Gleason 7 and/or in clinical T1c-T2a tumors.

Conclusions: In the intermediate risk group there was no significant outcome difference in patients with fPSM and NSM. The only important factor predicting PSM was cancer volume confirming the need for careful preoperative case selection.

11 Influence of nerve sparing surgery (NS) on (post)operative outcome, quality of life, oncological and functional results following robot assisted laparoscopic radical prostatectomy (RALP)

Results: The median age of the patients was 61.3 years old (range 39-75 years), the median PSA was 6.1 ng/ml (range 0.3-10 ng/ml), the median prostate size was 39.3 gr. (range 10-130 gr.) and the clinical stage was T1c in N=550 patients (88.5%) and T2a in N=71 patients (11.5%). The preoperative Gleason score was Gleason <7 in N=495 patients (79.7%) and Gleason 7 in N=156 patients (20.3%). The overall PSM rate was 4.5% (N=28 patients). PSM were noted in 3.2% of all T2 cases (19 of 577 T2 patients). PSM were evident in N=1 patient with a T2a tumor (0.15%), in N=2 patients with a T2b tumor (0.3%) and in N=16 patients with a T2c tumor (2.7%). PSM were noted in 22.7% of all T3 cases (10 of 44 T3 patients). N=9 exhibited PSM with a T3a tumor (20.4%) and N=1 patient PSM with a T3b tumor (2.27%). No stage T4 cases were evident.

Collette ERP1, Rambaran SS1, Kliffen M2, Engel RP1, Klaver OS1. 1Urology, Maasstad Hospital, Rotterdam, Netherlands; 2Pathology, Maasstad Hospital, Rotterdam, Netherlands Introduction: Analysis on influence and safety of NS on (post)operative outcome, quality of life (QoL), oncological and functional results 1 year after RALP. Materials & Methods: Prospective data analysis of 416 patients (pts) who underwent bilateral NS RALP (BilNS) (n=227) vs. unilateral NS RALP (UniNS) (n=113) vs. non nerve sparing RALP (NonNS) (n=76) between January 2009 and March 2011. Evaluated parameters: complications, positive surgical margins, PSA recurrence, QoL, continence and potency after 1 year. Continence and potency were measured by validated questionnaires (ICIQ-SF-UI and SHIM-IIEF-5).

Conclusions: Our findings suggest that patients eligible for bilateral intrafacial nerve sparing robot-assisted laparoscopic radical prostatectomy exhibit an excellent surgical margin status. In cases were the pathologic examination reveals an extracapsular extension the surgical margin status is compromised.

Results: Table 1 shows pt characteristics. No significant difference in number of complications between BilNS vs. UniNS vs. NonNS was seen (8 vs. 6 vs. 11%; p=0,56). Percentage positive surgical margins was not significantly different (16 vs. 15 vs. 18%; p=0,82; n=416), also within the pT2 group (13 vs. 10 vs. 8%; p=0,59; n=303). After BilNS PSA recurrence was significantly less compared to UniNS en NonNS (9 vs. 14 vs. 20%; p=0,04; n=397). Recovery of potency in preoperative potent pts was significantly superior after BilNS vs. UniNS and NonNS (61 vs. 12 vs. 6%; p<0,01; n=232). Recovery of continence was not significantly different (90 vs. 84 vs. 85%; p=0,28; n=366) as well as QoL (90 vs. 83 vs. 80%; p=0,07; n=385). In multivariate analysis BilNS was

10 Positive surgical margins in robotic prostatectomy: are they important and are they predictable? Brett A, Khan Y, Corbishley C, Issa R, Perry M, Anderson C. Urology, St George’s Hospital, London, United Kingdom 5


the best predictor of potency (p<0,01; n=340; HR=20,58; 4,5293,67 95% C.I.). No significant association was found between NS and continence or oncological outcome. BilNS was the best predictor of QoL (p<0,01; n=371; HR=4,17; 1,69-10,24 95% C.I.).

positive node status hormonal treatment. After a median follow up period of 11 months (range 3-31 months) none of the patients exhibited biochemical progression. Conclusions: Our findings suggest that the clinical stage of these patients does not reflect their pathologic stage. Patients should be informed that there is a great risk of exhibiting more aggressive tumors as preoperatively thought.

Conclusions: NS seems oncological safe; no significantly increased risk for positive surgical margins, PSA recurrence or complications was demonstrated in our series. BilNS is significantly associated with beter potency outcome, our cohort showed no significant difference regarding continence. In multivariate analysis significant difference in QoL was demonstrated, in favor of BilNS.

13 Surgical outcome of robot-assisted radical prostatectomy after a training program in a high-volume robotic centre Lumen N1, De Troyer B1, Fonteyne V2, Decaestecker K 1, De Meerleer G2, Oosterlinck W 1, Ost P2, Van Praet C1, Mottrie A3. 1Urology, Ghent University Hospital, Ghent, Belgium; 2 Radiotherapy, Ghent University Hospital, Ghent, Belgium; 3Urology, OLV Clinic, Aalst, Belgium Objectives: Robot-assisted radical prostatectomy (RARP) is an excellent technique in the treatment of prostate cancer but requires substantial surgical skills. A training program that allows the robot-surgeon to obtain these skills can overcome the problem of a learning curve. This report aims to evaluate the value of such a training program.

12 Clinicopathological characteristics and oncological outcomes of patients undergoing robot-assisted laparoscopic radical prostatectomy for prostate cancer after previous treatment with 5-alpha-reductase inhibitors for benign prostatic hyperplasia

Materials & Methods: Before starting RARP, a young urologist followed a 6-month training program at a high-volume robotic centre. The surgical outcome of the first 50 RARPs are evaluated and compared with a cohort of 50 open radical prostatectomies (ORP) performed by an experienced senior urologist during the same period. An independent t-test was performed for continuous variables and a chi-square test for categorical variables. Values were presented as mean (± standard deviation). Tumor stage and grade were similar in both groups. Nervesparing (uni- or bilateral) was significantly more performed with RARP. Follow-up duration was significantly longer in ORP.

Labanaris AP, Zugor V, Wagner C, Witt JH. Urology, Prostate Center Northwest, St. Antonius-Hospital, Gronau, Germany Objectives: 5-alpha-reductase inhibitors (5ARI) are a well accepted treatment for men with benign prostatic hyperplasia (BPH). Nevertheless a cohort of these patients will exhibit prostate cancer (PCa) at some point in their life. The aim of this study is to evaluate the clinicopathological characteristics and oncological outcomes of patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP) for PCa after previous treatment with 5ARI for BPH.

Results: Operation time was similar in both groups. Hospital stay was on average almost 1 day shorter with RARP. Catheterization duration was significantly shorter (8,6 days (± 6,9) vs. 15,2 (± 5,2); p<0.0001) and decline in Hb was significantly less in RARP (2,10 g/dl (± 1,09) vs. 4,03 (± 1,17); p<0.0001). Complication rate was not significantly different among groups but tended to be more severe in ORP. Positive surgical margin rate was 6% and 24% for respectively RARP and ORP (p=0.022). At 12 months, urinary continence was 81 and 82,9% for respectively RARP and ORP (p=1).

Materials & Methods: The records of N=36 men who underwent RALP from February 2006 to June 2011 were retrospectively reviewed. All patients previous to PCa detection have had previous treatment with 5ARI for BPH for at least 1 year. The parameters analyzed included: age, PSA values, prostate size, clinical stage, biopsy Gleason score, pathologic stage, Gleason score of prostate specimen, percentage of PCa found in the prostate specimen, positive margin status (PSM), lymph node status and biochemical progression in the follow up period, defined as PSA ≥0.2 mg/dl after nadir or never reached nadir.

Conclusions: These data indicate that a training program in a high-volume robotic centre can reduce the learning curve. RARP was associated with significantly less positive surgical margins, shorter catheterization duration and less blood loss compared to ORP.

Results: The average time of previous treatment with 5ARI for BPH was 36.4 months (range 12-120 months). The median age of the patients was 63.7 years old, the median PSA was 9.3 mg/ dl and the median prostate size 44.1 ml. The clinical stage was T1c for 52.7% of patients, T2a for 25%, T2b for 19.4% and T2c for 2.7%. The Gleason biopsy score was Gleason <7 in 52.7% of cases, Gleason 7 in 41.6% and Gleason >7 in 5.5%. The Gleason score of the prostate specimen was upgraded in 30.5% of cases. A Gleason <7 pattern was evident in 44.4% of cases, Gleason 7 in 19.4% and Gleason >7 in 36.1%. The pathologic stage was T0 in 8.3% of cases, T2 in 72.2%, T3 in 16.6% and T4 in 8.3%. The percentage of PCa found in the prostate specimen was 14.9% and PSM were encountered in 11.1% of patients. Lymph nodes were removed in 77.7% of cases and were positive in 8.3%. All patients with PSM and T3-T4 PCa underwent radiation after RALP and all with

14 Limited versus extended pelvic lymph node dissection in prostate cancer patients Maes H1, Van Praet C1, Ost P2, Villeirs G3, De Meerleer G2, Fonteyne V2, Lumen N1. 1 Urology, University Hospital Ghent, Ghent, Belgium; 2Radiotherapy, Ghent University Hospital, Ghent, Belgium; 3Radiology, Ghent University Hospital, Ghent, Belgium Objectives: Pelvic lymph node dissection (PLND) is currently the most reliable method for staging prostate cancer patients for lymph node metastases. Patients opting for primary external beam radiotherapy undergo a prior staging PLND at our centre 6


based on the risk of lymph node involvement as calculated with Roach’s formula. There is evidence that the increase in lymph nodes removed increases staging accuracy. The aim of this study is to compare the number of lymph nodes removed by limited PLND, removing only the nodes from the obturator fossa, versus extended PLND which comprises removal of at least the nodes from the obturator fossa and along internal and external iliac artery. Complications of both techniques are also compared.

an age and sex matched control cohort (Figure – broken line). The curve for patients with 0<BSI<=1 was closer to the BSI=0 curve than the corresponding BSI>1 curve, indicating that the tumor burden is important and not only the presence of metastases. In a multivariate survival analysis BSI was associated with survival (Hazard Ratio, 1.25; P<0.001). The Concordance index increased from 0.66 to 0.73 when adding BSI to a model containing clinical stage, PSA and Gleason score.

Materials & Methods: In this retrospective analysis, 102 patients had a PLND between 2006 and 2011 prior to primary external beam radiotherapy. Postoperative radiographic imaging with CT and MRI performed for radiotherapy planning was used to detect lymphocoeles. We compared limited (n=26) vs. extended (n=76) PLND with regards to retrieval of lymph nodes using student t-test and complications using Fisher’s exact test. Values were expressed as mean (± standard deviation). Except for 4 laparoscopic cases, all limited PLNDs were performed open, and 65 of 76 extended PLNDs were performed laparoscopically.

Conclusions: These data show that BSI can be used as a complement to PSA to stratify high risk prostate cancer patients at the time of diagnosis. BSI may play a role for the decision when to start hormonal therapy in advanced asymptomatic prostate cancer patients. The risk or expected median survival time based also on BSI analysis may be of value, for example, to advice patients with a strong wish to avoid treatment-related side-effects.

Results: With extended PLND a mean of 16,4 (± 7,8) lymph nodes were removed vs. 9,3 (± 4,3) with limited PLND (p<0.0001). Mean operation time was longer for the extended group (130 (± 38) vs. 89 (± 51) minutes; p=0.007) but mean hospital stay was shorter (4 (± 2,2) vs. 5,8 (± 2,0) days; p=0.0004). Perioperative and postoperative complications were similar for extended vs. limited PLND (5,2% vs. 2,7%; p=1 and 27,6% vs. 34,6%; p=0.66 respectively). Symptomatic lymphocoeles were observed in 7,9% after extended PLND vs. 15,4% after limited PLND (p=0.27), whereas radiographic lymphocoeles were seen in 56,6% vs. 50,0% respectively (p=0.72). Conclusions: In our series laparoscopic extended pelvic lymph node dissection allows for retrieval of almost twice the amount of lymph nodes, thus increasing staging accuracy, with a very limited increase in peri- and postoperative complications and radiographic lymphocoeles. It is a safe and effective technique to stage prostate cancer patients for lymph node involvement.

16 Trifecta rates and surgical margins; results and learning curve after robot assisted laparoscopic radical prostatectomy (RALP) Collette ERP1, Rambaran SS1, Kliffen M2, Engel RP1, Klaver OS1. 1Urology, Maasstad Hospital, Rotterdam, Netherlands; 2Pathology, Maasstad Hospital, Rotterdam, Netherlands

15

Introduction: Analysis of results and learning curve of trifecta rates and surgical margins; 1 year after RALP.

Risk stratification at the time of diagnosis based on bone scan index

Materials & Methods: Prospective data analysis of 416 patients (pts) who underwent RALP between January 2009 and March 2011. PSA rise (PSA ≥ 0,2) was used as surrogate endpoint for progression. Continence and potency were measured by validated questionnaires (ICIQ-SF-UI and SHIM-IIEF-5). All operations were performed by 1 surgeon. Pts were classified in chronological cohorts of 50 pts. Trifecta was defined as no PSA recurrence, continent and potent.

Kaboteh R , Damber JE , Gjertsson P , Höglund P , Lomsky M , Ohlsson M , Edenbrandt L1. 1Dept. of Molecular and Clinical Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden; 2Dept. of Urology, Institute of Clinical Sciences, Gothenburg University/Sahlgrenska University Hospital, Gothenburg, Sweden; 3 Competence Centre for Clinical Research, Lund University Hospital, Lund, Sweden; 4 Dept. of Theoretical Physics, Lund University Hospital, Lund, Sweden 1

2

1

3

1

4

Purpose: Bone scan index (BSI) is a method of expressing the tumor burden in bone as a percent of the total skeletal mass. BSI has been proposed as a response biomarker in castrationresistant metastatic prostate cancer. The purpose of this study was to explore BSI as a prognostic biomarker in a group of high risk prostate cancer patients at the time of diagnosis.

Results: Total cases: 416. Mean age: 64,6 years. Overall positive surgical margin rate was 16% (67/416 pts); in the pT2 group 12% (35/303) and in the pT3 group 28% (32/113). After 1 year 12% (48/397) of pts experienced no PSA recurrence. 86% (332/385) of pts experienced good quality of life. Of all preoperative potent pts, 61% (83/136) remained potent after bilateral nerve sparing surgery. After 1 year 87% (320/366) of pts were continent. Trifecta was reached in 59% (81/138) of all pts. Figure 1 shows percentage of negative surgical margins per series of 50 pts. Negative surgical margin rate in the pT2 group was 76%, 79%, 80%, 91%, 100%, 97%, 90%, 92% for respectively patient 1-50, 51-100, 101-150, 151-200, 201-250, 251-300, 301-350 en 351-400. Combination of “no PSA recurrence” and continence was 72%, 78%, 67%, 83%, 71%, 83%, 73%, 81%. Trifecta was reached in 60%, 56%, 53%, 50%, 58%, 84%, 58%, 50% of pts. The number of negative surgical margins of pts in the pT2 group shows a rising trend, which stabilizes after 150 procedures.

Patients & Methods: This retrospective study was based on 183 consecutive prostate cancer patients, who had undergone wholebody bone scans at the time of diagnosis and who were classified as high risk patients, i.e. at least one of the following criteria were fulfilled: T stage (T2c/T3/T4) or Gleason score (8-10) or PSA >20 ng/mL. BSI was calculated using an automated method. Results: The 5-year probability of survival for all patients was 54% and when this group was subdivided into the groups BSI=0, 0<BSI<=1 and BSI>1, the corresponding 5-year probabilities of survival were 79%, 64%, and 12%, respectively. The Kaplan-Meier curves for patients with BSI=0 and 0<BSI<=1 were close to that of 7


Conclusions: RALP is a safe and feasible intervention with acceptable learning curve. After approx. 150 procedures negative surgical margins rise above 90% in the pT2 group. Regarding trifecta or PSA recurrence in combination with continence, our cohort of the first 400 procedures established no clear trend.

Conclusions: We assessed LNI in patients which underwent LPLND because of prostate cancer. In the low risk group none had LNI, in the intermediate risk group 13 (8%) patients had LNI and in the high risk group 59 (30.7%) patients had LNI.

18 Robot-assisted laparoscopic radical prostatectomy in patients with PSA levels ≥50 ng/ml. Surgical and oncologic outcomes Labanaris AP, Zugor V, Wagner C, Addali M, Witt JH. Urology, Prostate Center Northwest, St. Antonius-Hospital, Gronau, Germany Objectives: To assess the surgical and oncologic outcomes in patients with preoperative PSA levels ≥50 ng/ml undergoing robot-assisted laparoscopic radical prostatectomy (RALP) for prostate cancer (PCa). Materials & Methods: The records of N=36 men who underwent RALP from February 2006 to July 2011 were retrospectively reviewed. All patients had preoperative PSA levels ≥50 ng/ml. The parameters analyzed included: age, prostate size, PSA values, biopsy Gleason score, clinical stage, pathologic stage, Gleason score of specimen, lymph node status, positive surgical margins (PSM), percentage of PCa found in the specimen, blood loss, skin-to-skin operative time, intraoperative complications, minor and major complications, disease-specific mortality as well as biochemical progression in the follow up period, defined as PSA ≥0.2 mg/dl after nadir or never reached nadir.

17 Lymph node involvement after laparoscopic pelvic lymph node dissection: a retrospective analysis of 391 cases van Dooren VPM, Fossion LMCL. Urology, Maxima Medisch Centrum, Veldhoven, Netherlands Introduction: Despite current use of MRI for lymph node staging, pelvic lymph node dissection (PLND) is still the gold standard to stage patients with prostate cancer. The EAU guidelines define three risk groups of lymph node involvement (LNI): the low risk group is stage cT1-cT2a, has a Gleason score ≤ 6 and PSA < 10 ng/ ml; the intermediate risk group is stage cT2b-cT2c, has a Gleason score 7 and PSA 10-20 ng/ml; the high risk group is stage cT3a and above, has a Gleason score 8-10 and a PSA > 20 ng/ml.

Results: The median age of the patients was 63.6 years old, the median PSA was 86.1 mg/dl (range 50-220 mg/dl) and the median prostate size 42.1 ml. The clinical stage was thought to be confined in 77.7% of cases and locally extended in 22.3%. The Gleason biopsy score was Gleason <7 in 19.4% of patients, Gleason 7 in 41.6% and Gleason >7 in 38.9%. Intraoperative complications were encountered in N=5 patients (13.8%), N=3 bilateral ureter stent insertion and N=2 rectum injury. Minor postoperative complications were encountered in 25% of cases and major in 5.5%. The median operative time was 154 min and median blood loss 155 ml. The pathologic stage was T2 for 16.6% of patients, T3 for 41.6% and T4 for 41.6%. A Gleason <7 pattern was no longer evident, a Gleason 7 was evident in 41.6% of patients and a Gleason >7 in 58.3%. The percentage of PCa found in the prostate specimen was 63.6% and PSM were encountered in 41.6% cases. Lymph nodes were removed in all cases and were positive in 27.7% patients. N=30 patients (83.3%) underwent adjuvant therapy, with N=18 cases (60%) undergoing radiation therapy and N=12 (40%) hormonal treatment. After a median follow up of 23.6 months (range 3–52 months) no disease-specific mortality was evident but N=15 patients (41.6%) exhibited biochemical progression.

Methods: We analyzed 391 patients (325 (83.1%) in center one and 66 (16.9%) in center two) who underwent a laparoscopic pelvic lymph node dissection (LPLND) from January 2000 until March 2012 in two general hospitals located in the Netherlands. The LPLNDs were done according the current standard LND template and were performed by three urologists. 206 (52.7%) patients received an endoscopic extraperitoneal radical prostatectomy (EERPE) in combination with a LPLND. 33 (8.4%) patients were treated with brachytherapy, 111 (28.4%) patients with external beam radiation therapy (EBRT), 40 (10.2%) patients with hormonal therapy and one (0.3%) patient with high-intensity focused ultrasound (HIFU). Clinical stage, preoperative PSA, Gleason score and positive biopsy cores were assessed. Lymph node samples were assessed by two pathology centers. Center one assessed 325 lymph node samples and center two assessed 66 lymph nodes. We divided the groups according to the risk groups stated in the EAU guidelines for prostate cancer.

Conclusions: Our findings suggest that RALP can be performed in this cohort of patients. Nevertheless, patients should be informed of the suboptimal oncologic outcomes as well as that it is only one part of a multimodality therapy needed.

Results: Mean age was 65 years. Mean lymph node count was 11 LN. 72 (18.4%) patients out of the 391 patients had lymph node involvement (LNI). LNI was seen in 8 (6.3%) patients with clinical stage cT1-cT2a and LNI was seen in 64 (24,3%) patients with clinical stage ≥ cT2b. 34 (17%) patients with LNI had Gleason score < 6 and 38 (19.9%) patients with LNI had Gleason score > 6. LNI was seen in 11 (8.5%) patients with PSA < 10 and in 61 (23.4%) patients with PSA ≥ 10. None of the patients in the EAU low risk group had LNI. In the intermediate risk group 13 (8%) patients had LNI, in the high risk group 59 (30.7%) patients had LNI.

8


19 The National Cancer Institute (NCI) Early Detection Research Network (EDRN) urinary PCA3 validation trial Wei JT 1, Sanda MG2, Thompson I3, Partin A4, Feng Z5, Sokoll L6, Groskopf J7, Brown E5, Lotan Y8, Kibel AS9, Busby E10, Bidair M11, Lin D12, Taneja S13, Viterbo R14, Kagan J15, Srivastava S15. 1Urology, University of Michigan , Ann Arbor, MI, United States; 2 Surgery, Beth Israel Deaconess Medical Center, Boston, MA, United States; 3Urology, University of Texas Health Science Center, San Antonio, San Antonio, TX, United States; 4Urology, Johns Hopkins Medical Institution, Baltimore, MD, United States; 5 Biostatistics and Biomathematics, Fred Hutchinson Cancer Research Center, Seattle, WA, United States; 6Pathology, Johns Hopkins Medical Institution, Baltimore, MD, United States; 7Gen-Probe Incorporated, San Diego, CA, United States; 8Urology, University of Texas Southwestern Medical Center, Dallas, TX, United States; 9Surgery, University of Washington St. Louis, St. Louis, MO, United Kingdom; 10Urology, University of Alabama at Birmingham, Birmingham, AL, United States; 11San Diego Clinical Trials, San Diego, CA, United States; 12Urology, University of Washington Medical Center, Seattle, WA, United States; 13Urology, NYU Langone Medical Center, New York, NY, United States; 14Surgical oncology, Fox Chase Cancer Center, Philadelphia, PA, United States; 15Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, United States Introduction & Objectives: Widespread use of PSA screening has raised concerns of overdiagnosis of low-risk and underdiagnosis of high-grade cancer. This is primarily due to the low sensitivity and specificity of PSA. PCA3, a non-coding large chain ribonucleic acid, is significantly overexpressed in cancer tissue and quantitatively measured by a novel urinary assay. The objective of this NCI EDRN trial was to conduct a comprehensive, independent validation of the PROGENSATM PCA3 Assay for the detection of prostate cancer. Methods: A prospective, PROBE-compliant NCI validation trial was undertaken at 11 clinical sites to evaluate PCA3â&#x20AC;&#x2122;s positive predictive value (PPV, PCA3 score > 60) in the initial biopsy setting and negative predictive value (NPV, PCA3 score < 20) in the repeat biopsy setting. PCA3 was obtained prior to biopsy but following an attentive DRE. We hypothesized that PPV for an initial prostate biopsy to be at least 55% and that NPV for a repeat biopsy to be at least 75%.The accuracy of PCA3 in detecting any prostate cancer and secondarily, high-grade cancer (Gleason sum > 7), was compared to PCPT risk calculator through ROC curve analysis. Results: 880 eligible men (mean age 62 years) were enrolled; 305 had a prior negative prostate biopsy. 99% had an informative PCA3 test. For the detection of any cancer, PPV was 80% (95% CI: 0.72-0.86) in the initial biopsy group while NPV was 88% (95% CI: 0.81-0.93) in the repeat biopsy group. PCA3 performance was superior to PCPT risk estimation in both the initial (upper figure, p<0.0001) and repeat biopsy setting (lower, p=0.001) and improved upon the detection of any cancer (p<0.006) and highgrade cancer (p<0.02) when combined with the PCPT risk model.

20 Correlation between biopsy Gleason score on prostate biopsy and on radical prostatectomy specimen: is there an improvement since the 2005 International Society of Urological Pathology Consensus Conference?

Conclusions: Independent validation of PCA3 demonstrated a high PPV in the initial biopsy setting and a high NPV in the repeat biopsy setting. Given the significant improvements in risk estimation over PCPT, PCA3 is expected to greatly enhance clinical decision making.

Dâ&#x20AC;&#x2122;Hondt F 1, Fonteyne V2, Villeirs G3, De Meerleer G2, Rottey S4, Oosterlinck W 1, Verbaeys A1, De Groote R1, Van Praet C1, Ost P2, De Visschere PJ3, Praet M5, Lumen N1. 1 Urology, University Hospital, Ghent, Belgium; 2Radiotherapy, University Hospital, Ghent, Belgium; 3Radiology, University Hospital, Ghent, Belgium; 4Oncology, University Hospital, Ghent, Belgium; 5Anatomopathology, University Hospital, Ghent, Belgium Introduction & Objectives: Histopathology obtained from prostate biopsy is a key step in the diagnosis of prostate cancer. The Gleason score is universally accepted as the preferred grading system for prostate cancer in histopathology obtained from prostate biopsy as well as from radical prostatectomy (RP). The biopsy Gleason score (b-GS) is a very important and independent 9


prognostic factor, used in several pre-operative nomograms and risk group stratifications, finally affecting the therapeutic decision making. A poor correlation between b-GS and radical prostatectomy Gleason score (RP-GS) has been reported. The Gleason grading system underwent its first major revision in 2005 at an International Society of Urological Pathology (ISUP) Consensus Conference. Has this revision led to a better correlation between b-GS and RP-GS since its introduction?

a doubling time PSA ≤ 0.2 ng/ml/year. Preliminary results of prospective studies show the feasibility and acceptance of these criteria by patients. However, details are to be made in terms of selection criteria and rigor in study’s methodology. Conclusions: The value of active surveillance as an alternative to immediate curative treatment has been demonstrated by the results of the PRIAS study. However, the variability of short-term results of prospective clinical studies should prompt caution and not to provide such monitoring as a standard, but rather an option as part of clinical research protocols.

Materials & Methods: This is a retrospective analysis (January 1997-August 2011) of 287 patients in which pathological data of both prostate biopsy and RP were available. Until 2006, the original Gleason score was used for grading the prostate biopsy and the RP specimen. Starting from 2006, the 2005 ISUP Gleason score was used. Due to this change in scoring system, patients were divided in two groups: those who underwent RP before 2006 (group 1; n=132) and starting from 2006 (group 2; n=155). The correlation between the b-GS and RP-GS was evaluated using Pearson’s correlation coefficient. The difference in correlation coefficient between group 1 and 2 was evaluated using Fisher’s Z test. The number of upgrading (higher RP-GS compared to b-GS) was also calculated and the difference between group 1 and 2 was evaluated with the χ2-test.

22 PCA3 surpasses best clinical judgment in selecting men requiring a repeat prostate biopsy: application of a RAND decision model to the REDUCE trial placebo cohort Tombal B1, Andriole GL2, Smets L3, Stoevelaar H3. 1Urology, UCL, Brussels, Belgium; 2 Urology, Barnes-Jewish Hospital, Washington University School of Medicine, St. Louis, MO, United States; 3Ismar Healthcare NV, Lier, Belgium

Results: For the whole study population, the correlation coefficient between b-GS and RP-GS was 0.447. The correlation coefficient in group 1 and 2 was 0.383 and 0.415 respectively. The improvement in correlation for group 2 compared to group 1 was not significant (p=0.75). Upgrading of the Gleason score was observed in 107 out of 287 patients (37.3%). In group 2, there was significantly less upgrading compared to group 1 (resp. 29 versus 46.9%, p=0.0026).

Introduction & Objectives: Overall, 10 to 35% of men with an elevated PSA and a negative initial biopsy (Bx) have prostate cancer (PCa) on systematic repeat Bx (rBx). Awareness of these data results in an increasing rate of rBx, with the consequence of increased risk of both minor and more serious complications (including septicaemia and hospitalization in 4.1%). Therefore, there is an urgent need to better individualize the decision for rBx to reduce the number of rBx while not underdiagnosing aggressive PCa. We developed a model using the RAND Appropriateness Method (RAM) to simulate best clinical judgment and incorporated PCA3 to select patients for rBx. PCA3 has been shown to predict the probability that a rBx will be positive and may be indicative of PCa significance.

Conclusions: After introduction of the 2005 ISUP Gleason score, there was no significant improvement of correlation between the b-GS and RP-GS. However, upgrading of Gleason score was significantly reduced after this introduction.

Methods: We have tested our RAM on a subgroup of the placebo cohort of the REDUCE study for which PROGENSATM PCA3 Scores were available. These men had a baseline PSA between 2.5 and 10 ng/mL, a prior negative Bx, and planned 2-year and 4-year rBx. For each scenario (without and with PCA3), the number of rBx and the number of missed high-grade (Gleason sum ≥ 7) cancers were assessed.

21 Inventory of the PRIAS study criteria for the low-risk prostate cancer active surveillance Khalil F, Iken A, Benslimane L, Faik M. Urology A, IBN SINA Hospital, Rabat, Morocco

Results: Data from 1024 subjects were available for analysis. Using their best clinical judgment (RAM), incorporating PSA, DRE, number of previous negative Bx, prostate volume and life expectancy, the expert panel ruled-out 26% of study-mandated rBx while missing 14 high-grade PCa (Table). PCA3 largely surpassed best clinical judgment by ruling-out 52% while missing only 7 high-grade PCa. The most efficient scenario was obtained by incorporating PCA3 results in the RAM model, leading to a 64% reduction in the number of biopsies while missing only 8 high-grade PCa.

Introduction: The value of active surveillance in localized prostate cancer or at low risk of progression as an alternative to immediate curative treatment has now been demonstrated. The optimization criteria for selecting patients for this monitoring is the subject of the study PRIAS (Prostate Cancer Research International: Active Surveillance). Other studies have followed and the results are variable. The aim of our study is to make an inventory of those criteria in order to optimize the patients selection for better management of this category. Materials & Methods: In this paper, we compared the results of the PRIAS study published in 2006 which included 500 patients, and the results of prospective studies published up to 2011 from a bibliographic research on the Medline/PubMed database using the following keywords: PRIAS study, localized prostate cancer, active surveillance.

The sensitivity, specificity, PPV and NPV of the RAM model including PCA3 for Gleason sum ≥ 7 cancer were superior to the model without PCA3 and the model with PCA3 alone.

Results: After the publication of the PRIAS study in 2006, 4 prospective studies (Klotz, ERSPC, ProtecT, PIVOT) and a multitude of cohorts (CapSure, SURACAP) were published in the literature between 2007 and 2011. Discussion: The inclusion criteria of the PRIAS study were prostate cancer with a maximum of cT2, a PSA ≤ 10 ng/ml, a Gleason score ≤ 6 with no more than 2 positive biopsies, and

Scenario

rBx (n) Reduction (%)

Missed highgrade PCab (n)

REDUCE

1024

0

a

RAM without PCA3

757

26%

14

PCA3 alone

488

52%

7

RAMa with PCA3

368

64%

8

a: expert recommendations; b: out of 55 Gleason sum ≥ 7 cancers

10


Conclusions: In men with a first negative biopsy, PCA3 alone or in combination with clinical judgment surpasses best clinical judgment as a strategy to avoid rBx without compromising diagnosis of high-grade cancer.

clinically useful information to make more informed repeat biopsy decisions.

24 Evaluation of the PCA3 test in men with PSA between 2.5 and 10 ng/mL undergoing first prostate biopsy

23 PROGENSA PCA3 molecular urine assay pivotal U.S. clinical study confirms utility for predicting repeat biopsy outcome

Jelski J1, Speakman M1, Oliver T2, Cuzick J2, Ho L2, Terry B2, Pinney L2, Turner B3, Hines J4, Green J4, Barua J5, Ahmad A 2, Chinegwundoh F6, Ancheta J7, Lee A5, Akhter W8, Ali S3, McMeekin F 1, Segaran S1. 1Urology, Musgrove Park Hospital, Taunton, United Kingdom; 2Queen Mary University London, Wolfson Institute of Preventive Medicine, London, United Kingdom; 3Urology, Homerton Hospital, London, United Kingdom; 4 Urology, Whipps Cross Hospital, London, United Kingdom; 5Urology, BHR University Hospitals, Goodmayes, United Kingdom; 6Urology, Newham University Hospital & Barts and the London NHS Trust, London, United Kingdom; 7Urology, Barts and the London NHS trust, London, United Kingdom; 8Urology, Newham University Hospital, London, United Kingdom

Groskopf J1, Ward J2, Hertzman B3, Bailen J4, Franco N5, Williams T6, Koziol I7, Henderson RJ8, Efros M9, Bidair M10, Gittelman M11. 1Gen-Probe Incorporated, San Diego, CA, United States; 2Urology, MD Anderson Cancer Center, Houston, TX, United States; 3Tri-State Urological Services, Cincinnati, OH, United States; 4Metropolitan Urology, Jeffersonville, IN, United States; 5Specialists in Urology, Naples, FL, United States; 6Florida Urology Specialists, Sarasota, FL, United States; 7 Virginia Urology, Richmond, VA, United States; 8Regional Urology, Shreveport, Shreveport, LA, United States; 9AccuMed Research Associates, Garden City, NY, United States; 10San Diego Clinical Trials, San Diego, CA, United States; 11Urology, South Florida Medical Research, Aventura, FL, United States

Introduction: The value of PSA screening continues to be questioned due to both the over-diagnosis of indolent cancer and the number of false positive tests, leading to over-treatment. European and American studies have shown the clinical utility of PCA3 in predicting prostate biopsy outcome, but to date there has been no large study in the UK. Various ‘cut-off’ levels have been described for PCA3 each with their own merit. A cut-off of 35 provides the best balance between sensitivity and specificity; however in clinical practice a cut-off of 25 may provide higher sensitivity so that more cancers are identified. This abstract reports preliminary results from the evaluation of PCA3 testing in 6 UK centres in a cohort of men undergoing a first prostate biopsy.

Introduction & Objectives: The PROGENSATM PCA3 molecular urine assay has demonstrated utility to supplement existing methods for guiding repeat prostate biopsy (rBx) decisions. In this multi-center prospective pivotal clinical study, we evaluated its clinical performance in men undergoing rBx. Materials & Methods: Subjects were enrolled from 14 community-based urology clinics, group health organizations and academic institutions. The study population consisted of 466 men ≥ 50 years of age who had ≥ 1 prior negative prostate biopsy and were recommended for rBx. Urine samples were collected prior to biopsy, and PCA3 Scores determined using the PROGENSA PCA3 Assay. PCA3 Scores were correlated with rBx outcome. Multivariable logistic regression (LR) was performed with factors for PCA3 Score, age, race, serum PSA level, DRE result, family history and number of previous negative biopsies.

Patients & Methods: Patients with PSA between 2.5-10 ng/mL, scheduled for a first prostate biopsy were included from 6 UK centres. First catch urine samples were collected after digital rectal examination (3 strokes per lobe) and the PCA3 Score was determined using the PROGENSATM Assay, blind to outcome variables, and compared to PSA as a predictor of positive biopsy at PCA3 cut-offs of 35 and 25.

Results: Prostate cancer was diagnosed in 21.9% (102/466) of subjects. Men with PCA3 Scores < 25 were 4.6 times more likely to have a negative rBx than men with PCA3 Scores ≥ 25. At this cutoff, the NPV was 90% (Table); 8 high-grade (Gleason sum ≥ 7) cancers would have been missed whereas 50% of rBx would have been avoided. The PCA3 Score significantly increased the predictive accuracy of the LR model: at 90% sensitivity, addition of the PCA3 Score to the LR model increased specificity by 22.6 (90% CI: 9.0-33.1), PPV by 6.4 (2.8-9.6) and NPV by 7.1 (1.7-13.4) percentage points relative to the LR model without the PCA3 Score.

Results: 317 men have been enrolled; 245 are currently evaluable and 104 (42%) had cancer on biopsy. PCA3 levels increased with age (1.92 units/yr, P<0.0001). PCA3 was strongly predictive of positive biopsy (odds ratio [OR]=2.88 at 35 unit cut-off and OR=2.21 at 25 unit cut-off), more so than PSA value (AUC=0.687 vs 0.576, P=0.02). Age-specific PCA3 improved predictive power (OR=3.2 at 35 unit cut-off and OR=2.96 at 25 unit cut-off), but PCA3 Scores were only slightly higher in men with Gleason grade 7 vs 6 cancers (OR 1.49, ns).

Table: Performance characteristics of PCA3 at a cutoff of 25 (95% CI) Sensitivity

Specificity

NPV

PPV

Conclusions: Data confirms that PCA3 testing helps identify patients likely to have cancer, but these data were not predictive of Gleason grade. PCA3 can help in counselling patients whether to perform a first or subsequent biopsy and may help patient choice in early prostate cancer. Follow up is on-going to determine the value of PCA3 in predicting outcome particularly in those on active surveillance.

Odds ratio

77.5%

57.1%

90.0%

33.6%

4.6

(68.4-84.5)

(52.0-62.1)

(86.593.1)

(30.037.2)

(2.75-7.62)

Conclusions: The clinical utility of the PROGENSA PCA3 Assay for predicting rBx outcome was confirmed in a multi-center pivotal U.S. clinical study. Lower PCA3 Scores were associated with a decreased likelihood of a positive rBx. The NPV was 90% at a PCA3 Score cutoff of 25; at this cutoff only 8 high-grade cancers would have been missed whereas 50% of rBx could have been avoided. LR analysis confirmed that the PCA3 Score supplements serum PSA and other clinical information for more accurate prediction of repeat biopsy outcome. The PROGENSA PCA3 Assay provides clinicians and patients with independent, 11


25

26

Evaluation of the economic burden and impact on patients’ quality of life of metastatic castration resistant prostate cancer: implementation of an observational study in 6 European countries

How do residents perform on transrectal ultrasound guided prostate biopsy? Ramos R1, Neves T2, Rodrigues T2, Mota R2, Lopes F2, Monteiro H2. 1Urology, Instituto Português de Oncologia, Lisboa, Portugal; 2Urology, Centro Hospitalar Lisboa Ocidental, Lisboa, Portugal

Dass RN1, Hamberg P1, Spencer M1, Wheatley Price P1. 1HEMAR (Health Economics, Market Access and Reimbursement), Janssen EMEA, Beerse, Belgium; 2Department of Internal Medicine and Prostate Cancer Center, Sint Franciscus Gasthuis, Rotterdam, Netherlands

Introduction: Transrectal ultrasound guided biopsy remains the standard for the diagnosis of prostate cancer. Multiple variables have been suggested to affect cancer positivity rate including core fragment length and operator. Fragment length is recognized as a quality parameter. Reports on prostate biopsies performed by experienced operators have revealed an operator-dependent variable. The role for a learning curve is not yet clear.

Background: Information on costs related to the management of metastatic castration resistant prostate cancer (mCRPC) is limited. The development of robust cost-effectiveness models in patients with mCRPC requires to collect accurate data on medical resource use and expenditures, as well as patients’ quality of life (Qol).

Our aim is to assess prostate biopsy quality when performed by urology residents, evaluate whether a learning curve exists and attempt to identify causes for differences between operators.

Objectives: To present the design and implementation of a study, which aimed at evaluating direct and indirect costs, associated with mCRPC management and Qol at different disease stages.

Methods: Pathological reports from consecutive biopsies performed during 2011 by three urology residents with specific training were reviewed. Double sextant biopsies were performed with side firing probe and under local anesthesia. Repeat and saturation biopsies were excluded. Relevant patient and biopsy specimen data were collected. Pathological diagnosis was classified as cancer, high-grade prostatic intraepithelial neoplasia, prostatitis and normal. Regression analysis was used to evaluate whether a learning curve for fragment length or cancer positivity exists for two of the operators who started performing biopsies during 2011. SPSS 17.0 was used for statistical analysis.

Methods: The study was conducted in centres specialised in prostate cancer treatment in 6 countries: Belgium, France, Germany, Sweden, Netherlands, and United Kingdom. The study combined a retrospective chart review with a cross-sectional data collection at inclusion. Patients with a confirmed diagnosis of mCRPC and a documented disease progression were screened from the file system of participating sites. In Germany, the Association for Interest Group for Quality Assurance in the Work of Office-based Urooncologists (IQUO) database was also used to identify potential sites and to screen eligible patients.

Results: Ninety eight first time biopsies performed between January and December 2011 were included in the final analysis. Fragment length (mean 11.49 mm) was not significantly different between operators. Overall prostate cancer detection rate was 53.1% with statistically different detection rates between operators (p=0.027). Patient age, PSA, and positive findings on digital rectal examination and ultrasound were not statistically different between operators. Fragment core length was not associated with cancer detection rate nor any other pathological diagnosis. No learning curve was detected nor did the most experienced operator have longest fragment core length or cancer detection rate.

Screened patients were invited to participate in the study at the time of a regular follow-up visit. A total of 900 were expected. Medical resource use over the previous 2 years (or from diagnosis of mCRPC onwards if <2 years) were retrospectively collected in Case Report Forms (CRF) from patients’ medical charts by site staff or trained external clinical research technicians (CRT). Direct costs outside of health care, indirect costs (SF-HLQ) and Qol (FACT-P and EQ-5D) were directly collected from the patient at the inclusion visit.

Conclusions: There are significant differences in prostate cancer detection rates between operators. No learning curve for fragment length or cancer detection could be identified for the two younger residents. Causes for differences between operators performing biopsies on apparently similar patient population remain an unresolved issue worthy of further investigation.

Results: Regulatory submissions were initiated in January 2011. The first patient was included in May 2011. After a 10-month inclusion period, 47 sites from 6 countries were initiated and included from 2 to 42 patients. A total of 707 patients were included: 137 CRT visits were performed, 698 CRF and 687 patient questionnaires were collected. The main recruitment barrier was the lack of eligible patients owing to participation in clinical trials within the period of data collection.

27 Computer-aided (HistoScanning™) biopsies versus conventional TRUS-guided prostate biopsies: do targeted biopsy schemes improve the cancer detection rate?

Conclusions: The collection of a robust set of data from various sources was ensured through a progressive design, which combined a comprehensive retrospective 2-year chart review with a “current snapshot” via the completion of a dedicated questionnaire by the patient.

Hamann MF, Hamann C, Naumann CM, Juenemann KP. Department of Urology and pediatric Urology, University Hospital of Schleswig -Holstein, Campus Kiel, Kiel, Germany Introduction: To define potential improvement in prostate cancer detection by application of a computer-aided, targeted biopsy regimen (HistoScanning™).

12


Materials and Methods: We analysed 80 patients who underwent systematic transrectal, targeted transrectal and targeted perineal biopsies. Each of them was diagnosed preoperatively by HistoScanning™, defining a maximum of 3 suspicious areas. These areas were biopsied both transrectally and via the perineum with a maximum of 3 cores per location.

29 Adoption of a decision algorithm including PCA3 for repeat prostate biopsy may lead to considerable cost savings in France

Results: Overall we detected prostatitis in 30 patients (37.5%), premalignant lesions in 10 (12.5%) and prostate cancer in 28 (35%) patients of our study group. 78.6% of all cancers were detected transrectally using 14 cores by systematic biopsy. With a maximum of 9 targeted cores, 82.1% of all cancers were detected via the targeted perineal approach. 53.6% were detected using a maximum of 9 targeted cores via the targeted transrectal approach.

Malavaud B1, Cussenot O2, Mottet N3, Rozet F4, Ruffion A5, Smets L6, Stoevelaar H6. 1 Urology, CHU de Toulouse, Hôpital de Rangueil, Toulouse, France; 2Urology, CHU Hôpital Tenon (AP-HP), Paris, France; 3Urology, Clinique Mutualiste, St Etienne, France; 4Urology, Institut Montsouris, Paris, France; 5Urology, Hôpital Henry Gabrielle, Lyon, France; 6Ismar Healthcare NV, Lier, Belgium Introduction & Objectives: The PROGENSA PCA3 Score is predictive of first and repeat prostate biopsy (Bx) outcome. A recently conducted RAND Appropriateness Method (RAM) study from 12 European urologists reported that PCA3 Scores were instrumental in taking appropriate Bx decisions, mainly in men with ≥ 1 negative prior Bx. In this analysis, the RAM expert recommendations - without or without consideration of the PCA3 Score - were applied to a modern French cohort of biopsied men to determine the impact of the PCA3 Score on Bx decisions and associated costs.

Conclusions: The presented targeted biopsy scheme achieved an overall detection rate of 85% of PSA-relevant, pathological lesions within the prostate. Thus, the presented procedure shows an improved detection rate in comparison to standard systematic prostate biopsies, while reducing the number of cores. Furthermore, the perineal HistoScanning-aided approach seems to be superior to the transrectal approach with respect to the prostate cancer detection rate. The presented procedure might be a step towards reliable ultrasound-based tissue characterisation and towards fulfilling the requirements of novel therapeutic strategies.

Materials & Methods: The sample consisted of 808 French men who had Bx in 2010 (78% first, 22% repeat). For these men, the proportion for which Bx would have been inappropriate (i.e. could have been avoided) was calculated without and with knowledge of the PCA3 Score. In addition, we estimated the impact on the number of Bx and associated costs. Hypotheses for the cost calculations were 225,000 Bx/year (78% first, 22% repeat), average cost/Bx 800€, average cost for managing complications/ Bx: ranging from 0€ (scenario 1) to 100€ (scenario 2) to 280€ (scenario 3) and costs PCA3 Score 300€. Scenario 1 is unlikely as Bx results in hospitalization in 4.1%.

28 The active surveillance criteria for prostate cancer among urologists in UK Hawizy A1, Gujral SJ2, Kelkar A 2, Parker C3. 1Urology, Colchester General Hospital, Colchester, United Kingdom; 2Urology, King George Hospital, London, United Kingdom; 3Urology, The Royal Marsden Hospital, London, United Kingdom

Results: Complete profiles (based on life expectancy, DRE, PSA, prostate volume, number of prior negative Bx) were available for 698 men. In the model without PCA3, 2% of all Bx were considered inappropriate. Knowledge of PCA3 would have avoided another 7% of Bx. Repeat Bx would have been avoided in 5% without PCA3 and in 37% with PCA3. This would result in 18,345 fewer repeat Bx, which would be budget neutral in scenario 1 and save 5 million € in scenario 3 (Table).

Introduction: Active surveillance (AS) is a valid option for localised prostate cancer (PC) and should be offered to all patients who are suitable for radical treatment according to NICE guidelines. However, there is no uniform definition of criteria on selection and follow-up of these patients in published data. We carried out an online survey to all BAUS members to review their criteria on AS in PC. Methods: An online survey was sent to 1200 UK BAUS members to assess their criteria for selection, follow-up and intervention of patients who are on AS for PC.

Number of Bx First

Results: Eleven percent (134/1200) responded and completed the questionnaire. Regarding PSA limits, 61.2% of the urologists chose PSA ≤ 10 ng/ml and only 25.5% use PSA density. Gleason ≤ 6 (47.35%), clinical stage ≤ T1c (32.8%), number of positive cores ≤ 3 (34.4%) are other selection parameters. Only 55.6% will use core length and 51.5% will perform Magnetic Resonance Imaging as part of the disease staging while 38.6% do not perform any imaging. During the follow-up only 18.8% will review their patients every 3 months and 57.1% do not perform digital rectal examination. First repeat prostate biopsy is performed at 12 months by 44% of the urologists and 19% at 18 months. Increased Gleason score and PSA doubling time are the 2 main criteria that would trigger intervention (87.3% and 73% respectively).

Repeat

Total

Costs: million € Scenario Scenario Scenario 1* 2* 3*

Current practice

175,500 49,500

225,000 180.00

202.50

243.00

RAM + PCA3

175,500 31,155

206,655 180.17

200.84

238.04

Savings

0 (0%)

18,345 (8.2%)

1.66

4.96

18,345 (37%)

-0.17

* Average cost for complications per Bx: scenario 1: 0€, scenario 2: 100€, scenario 3: 280€

Conclusions: Adoption of RAM expert recommendations including PCA3 for repeat Bx decisions in clinical practice in France would reduce the number of repeat Bx and control costs.

Conclusions: There was no uniform or even majority agreement in most of the criteria used for selection, follow-up and repeat biopsy for PC patients on AS.

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30

31

Fractal geometry enables the objective grading of prostate cancer; Gleason 3+4 â&#x2030;  Gleason 4+3!

Safety of abiraterone acetate in patients with castration resistant prostate carcinoma and concomitant cardiac risk factors

Waliszewski P1,2, Tanase M3, Abu Eid R4, Klonowski W5, Pierzchalski M5, Stepien P5, Stepien RA5, Luedecke G6, Wagenlehner F6, Gattenloehner S7, Weidner W6. 1 Department of Urology, Andrology and Pediatric Urology, Justus-Liebig University, Giessen, Germany; 2Complexity Research Inc. , Poznan, Poland; 3Department of Computer Sciences, Politehnica University, Bucharest, Romania; 4Georgia Cancer Research Center, Health Sciences University, Augusta, GA, United States; 5Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences, Warsaw, Poland; 6Department of Urology, Andrology and Pediatric Urology, JustusLiebig University, Giessen, Germany; 7Department of Pathology, Justus-Liebig University, Giessen, Germany

Procopio G1, Verzoni E1, de Braud F 1, Salvioni R2, Stagni S2, Villa S3, Bedini N3, Valdagni R4. 1Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; 2 Urologic Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; 3 Radiation Oncology 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, 4 Prostate Cancer Program, Radiation Oncology 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy Introduction: Abiraterone acetate (AA) is an inhibitor of the extragonadal androgen biosynthesis that prolongs overall survival in castration resistant prostate cancer (CRPC) patients who have received a chemotherapy including docetaxel. The most common adverse events related to AA therapy were fluid retention, hypertension, hypokalemia and cardiac disorders. No safety data are available in patients with concomitant cardiac disease.

Background: Tumor grading is an important prognostic criterion for prostate cancer patients. Subjective scoring according to the Gleason system is influenced by intra- and interobserver variability in up to 80% of cases. There is a need for objective grading, which would eliminate over- or under-scoring and enable comparison of results between centers.

Methods: Metastatic CRPC patients were enrolled in this prospective study if they were also suffering from a concomitant controlled cardiovascular disease. AA 1000 mg per day and prednisone 5 mg bid were administered orally until grade 3-4 adverse events (AE) or disease progression. The primary endpoint was the safety profile while the secondary endpoints were progression-free survival and PSA response.

Methods : Fractal analysis, based upon self-similarity of geometric structures, enables characterizing complex patterns by a numerical value of fractal, i.e. non-integer dimension. We compared spatial distribution of cell nuclei in prostate tissues by calculating capacity, information and correlation dimension based on the Grassberger-Procaccia algorithm as well as Higuchi dimension. We also constructed a local structural correlation diagram by a novel Java-based image-transforming computer algorithm to show how some local blocks of patterns are correlated and to characterize the cell distribution by diagram size. Morphometric features of cells were investigated in 2-dimensional tissue slides after applying the colour deconvolution algorithm.

Results: From April to September 2011, 41 CRPC patients with concomitant cardiovascular disorders have been treated with AA. Main patients characteristics were: median age 71 years (range 5781 years); baseline mean PSA value 40 ng/ml (range 6.32-995 ng/ml); the most common sites of disease were bone(27 pts, 81%), lung (11 pts, 33%) and liver (5 pts, 15%). All patients were previously challenged with at least 2 lines of hormone therapy and 1 chemotherapy regimen including docetaxel. The most common pre-existing cardiac disorders were hypertension 22 (66%), arrhythmias 4 (12%), cardiac ischemia 3 (9%) and conduction irregularity 2 (4%). Additionally 9 patients (27%) had metabolic disorders including dislipidemy and hyperglycemia. AA was feasible without inducing grade 3-4 AE nor treatment modification. The most common grade 1-2 AE were asthenia (27%), hypertension (18%) and fluid retention (28%). After a median time of treatment of 4 months (range 2-7 months) no dose modifications due to toxicity were required. No efficacy data are still available.

Results: Fractal structure was found in all analyzed cases. We obtained the following values of capacity, information, correlation, and Higuchi dimension: 1.451 (018), 1.521 (014), 1.986 (004) n=18 for normal prostate; 1.469 (022), 1.530 (017), 1.972 (008) n=15, 1.417 (046) n=22, Gleason 3 pattern; 1.601 (019), 1.648 (015), 1.938 (011) n=18, 1.322 (044) n=32, Gleason 4; and 1.769 (011), 1.766 (010), 1.895 (010) n=10, 1.240 (097) n=2, Gleason 5, respectively. More random distribution of cell nuclei was associated with more expanding diagram. The mean values of the diagram size were 9.5, 30.3, 41.5, 48.6, respectively. The mean diagram size for Gleason score 3+4 was lower than for Gleason score 4+3. With regard to the morphometric cell analysis, sphericity, circularity, and solidity shape were found to be statistically different between cases with Gleason score 3, and those with a score of 4 and 5 (p<0.05). Based on the cellular morphology parameters, discriminant analysis with leave one out showed that 60% of Gleason score 3 and 4 cases, 63% of Gleason score 4 and 5 cases and 62% of Gleason score 3 and 5 cases could be correctly classified.

Conclusions: Treatment with AA was feasible and well tolerated also in patients suffering from cardiac comorbidities and risk factors for cardiovascular disease.

32 Radical laparoscopic prostatectomy for locally advanced disease Brandenburg JJI, Fossion LMCL. Urology, Maxima medisch Centrum, Veldhoven, Netherlands

Conclusions: This approach based upon fractal geometry allows accurate objective grading of prostate cancer and suggests the need for incorporating more objective criteria in the grading system.

Introduction: Surgical treatment for locally advanced prostate cancer is still controversial despite recent series in literature. The EAU guideline also mentions prostatectomy as an option in select cases. Methods: Between May 2006 and Febuary 2012 a total of 240 consecutive men underwent endoscopic extraperitoneal radical

14


prostatectomy (EERPE) with or without extended lymph node dissection depending on clinical staging and nomograms at our institution. We analysed the data of 75 patients with pT3 prostate cancer regarding the value of preoperative staging, complications and mid-term oncological follow-up.

AGE GROUPS 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85+ Total

Results: Mean age and initial PSA were 66 years (range 54-76) and 16.6 ng/dl (range 2.1-190). Clinical staging in the overall group: 80 cT1c, 126 cT2, 34 cT3. In 24 out of 34 cT3 tumours it involved a true pT3 (29% overstaging). MRI was performed in 45 cases. Sensitivity for lymph node metastases only 11%, specifity 86%. Mean operating time was 231 minutes (120-364), mean blood loss 596 mililiters (50-2000). Pathological staging in the overall group: 5 pTx, 149 pT2, 75 pT3, 1 pT4. Positive surgical margins (PSM) were found in 23 pT3a (52%) and 21 pT3b (68%). PSM in pT2 were 20%. Lymph node metastases were found in 12 patients: 4 pT3a (9%) and 8 pT3b (25%). Mean lymph node count was 12 (1-29). A total of 65% of patients experienced no complications. Most complications were Clavien 1-2, 4% Clavien 3b. Mean follow-up was 27 months (3-61). Non-detectable PSA levels (<0.1 ng/dl) were found in 46 patients (61%). In case of pT3a this was 75%, pT3b 41%. In 20 cases there was an indication for salvage radiotherapy, after which a non-detectable PSA was reached in 5 patients.

1999-2004 NUMBER INCIDENCE 1 0,09 0 0,00 3 0,25 9 0,67 14 1,08 45 2,96 88 4,24 182 6,58 176 5,13 141 3,27 53 2,01 692 26,28

NUMBER 0 1 2 18 56 102 148 229 248 155 63 1022

2005-2010 INCI% DENCE CHANGE 0,00 N.A 0,08 N.A 0,17 -47 1,34 100 4,34 301,8 6,71 126 7,13 68,1 8,29 25,9 7,23 40,9 4,19 28,1 2,39 18,9 41,87 569,3

*Per 100.000 person-years, age-adjusted using the world standard

Conclusions: Prediction of locally advanced prostate cancer is difficult with still a lot of overstaging. Postoperative complications and PSM are comparable to the literature. Oncological results seem promissing.

33

34

Prostate cancer epidemiology in a rural area of North Western Greece

The initial management of prostate cancer in France in 2010: results of a retrospective chart review of 808 men having prostate biopsy

Grivas N, Hastazeris K, Kafarakis V, Tsimaris I, Stavropoulos NE. Urology, General Hospital Hatzikosta, Ioannina, Greece Objectives: To collect prostate cancer epidemiology data from Epirus; a rural area of North Western Greece.

Malavaud B1, Bordier B1, Cussenot O2, Meesen B3, Mottet N4, Rozet F5, Ruffion A6, Stoevelaar H3. 1Urology, CHU de Toulouse, Hôpital de Rangeuil, Toulouse, France; 2 Urology, CHU Hôpital Tenon (AP-HP), Paris, France; 3Ismar Healthcare NV, Lier, Belgium; 4Urology, Clinique Mutualiste, St Etienne, France; 5Urology, Institut Montsouris, Paris, France; 6Urology, Hôpital Henry Gabrielle, Lyon, France

Methods: We reviewed data from 4 hospitals of 4.975 patients who were submitted to prostate biopsy in Epirus in the 12-year period 1999 to 2010. Two 6-year periods were compared (19992004 and 2004-2010). All cases of prostate cancer confirmed by biopsy were recorded and age-standardized incidence rates per 100.000 males were calculated. We also recorded the clinical stage of prostate cancer and correlated this with PSA and Gleason score.

Introduction & Objectives: In clinical practice it is often uncertain which men need a (repeat) prostate biopsy (Bx) and which men with prostate cancer (PCa) are suitable for active surveillance (AS) as guidelines are often not straightforward at the patient-specific level. There is also limited information on which men eventually have a Bx and on initial treatment choice. We aimed to make an inventory of the characteristics and initial treatment choice of men who underwent Bx in clinical practice in France.

Results: There were a total of 1.714 new cases of prostate cancer in Epirus during 1999-2010 and the mean total annual ageadjusted incidence was 34/100.000 men. The mean incidence during 1999-2004 was 26/100.000 while the mean incidence during 2005-2010 was 42/100.000 (Table and Figure). The mean age at diagnosis was 74 years old. The most common Gleason score was 6. The most common clinical stage was cT2. The median PSA at diagnosis was 10,83. There was a statistical significant difference between stage cT4 and all other stages regarding the PSA value (p=0,000). There was a positive correlation between Gleason score and PSA (p= 0,013).

Materials & Methods: This was a French multi-centre, retrospective chart review study including men who underwent Bx in 2010. Data on clinical variables were collected using an electronic data capture system. To avoid selection bias inclusion of patient cases took the order of ‘most recent case to less recent case’. Results: 808 men were included. 632 men (78%) had an initial Bx and 176 men (22%) ≥ 1 repeat Bx (Table). The mean age was 64 years and the mean (median) PSA was 11.6 (7.0) ng/mL. 23% of men were ≥ 70 years, 25% had a PSA > 10 ng/mL and 28% had a suspicious DRE (Table). 52% of men had a positive initial Bx and 26% a positive repeat Bx. In men with a positive biopsy a mean of 12 cores (range 1-42) was performed. 111 patients (34%) had low-risk PCa (NCCN classification: stage T1c-2a, PSA < 10 ng/mL and Gleason sum < 7), 195 (59%) were at intermediate/high risk of disease progression and in 7% this information was missing. 29% of patients had clinical stage ≥ T2b, 61% had > 20% of

Conclusions: There was an almost two-fold increase in incidence of prostate cancer in this rural area of North Western Greece. These results are in accordance with the incidence rise recorded in neighboring countries of South East Europe. However we should keep in mind the risk of overdiagnosis and the detection of low-risk cancers that would not have caused morbidity or death during a man’s lifetime anyway. Table: Age-adjusted incidence rates* of prostate cancer in Epirus, 1999-2004 and 2005-2010 15


positive cores and 52% had a Gleason sum ≥ 7. The most common treatment was radical therapy (radical prostatectomy or radiation therapy) in 54% of patients. Of those at low risk, 38% received AS and 40% radical therapy.

shown that HPV is frequently detected in prostate lesions and prostate cancer. HPV E7 monoclonal antibody should be further studied to understand if it could be useful together with ki67, to better define low grade non-aggressive tumours and the prognosis of prostate cancer. This first report showed that nuclear and cytoplasmic E7 positivity have different meanings. The first one is associated to low nuclear degree and the second one to highly replicative recurrent tumours.

Table: Distribution of clinical variables (n=808) Variable

Value

Percentage

Age (years)

< 70 ≥ 70

77 23

Life expectancy (years)

≥ 10 < 10

90 10

36

DRE

Normal Suspicious Unknown/not reported

59 28 13

Computer-aided ultrasonography-guided biopsy: accurate tool in prostate cancer detection

Previous biopsies

Not performed 1 negative biopsy ≥ 2 negative biopsies

78 14 8

De Coninck V 1, Braeckman J1, Autier P2, Michielsen D1. 1Urology, UZ Brussel, Jette, Belgium; 2Epidemiology, International Agency for Research on Cancer, Lyon, France

Prostate volume (cc)

< 30 30-60 > 60

14 66 20

Objectives: To evaluate the efficiency of computer-aided ultrasonography-guided biopsy for prostate cancer detection in men at high risk.

PSA (ng/mL)

<3 3-10 > 10

3 72 25

Methods: During a 6-months period, 41 men were referred for prostate biopsy under computer-aided ultrasonographic guidance. This imaging technique has been developed to detect or exclude prostate cancer with high accuracy. Men were selected on DRE suspicious for prostate cancer, PSA > 4.0 ng/mL or PSA velocity > 0.75 ng/mL/year, and suspicious computer-aided ultrasonographic examination. The number of random biopsy cores varied depending upon the prostate volume. Targeted biopsies were taken in case of computer-aided ultrasonographic area suspicious for malignancy. Directed biopsies were performed by extrapolating suspicious foci on computeraided ultrasonography to transrectal ultrasound images. The Pearson’s chi-squared test was used to determine the statistical significance for the comparison of data.

Conclusions: The French sample of men biopsied in clinical practice in 2010 was at a relatively high risk of having PCa. Radical therapy was the most common treatment choice. In men with low-risk PCa, radical therapy and AS were used most often and to the same extent.

35 HPV E7 monoclonal antibody may help to define better prognosis of prostate cancer Stanta G1, Barbazza R1, Roggero E2, Marchesin F 1, Pracella D1, Bonin S1. 1Medical Sciences, University of Trieste - Cattinara Hospital, Trieste, Italy; 2Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Switzerland

Results: Prostate cancer was found in 17 of 41 men (41%). In patients with cancer, computer-aided ultrasonography-guided biopsy was 4.5-fold more likely to detect cancer than random biopsy. Prostate cancer detection rate for random biopsy and directed biopsy was 13% and 58%, respectively. Computer-aided ultrasonography-guided biopsy significantly decreased the number of biopsy necessary (p-value < 0.0001).

Introduction: There is a lot of confusion about the persistence of HPV infection in the prostate. A new commercial monoclonal antibody against E7 can give us the chance to study prostate tumours by searching if this antibody can be useful in diagnosis and in predicting better prognosis.

Conclusions: We conclude that computer-aided ultrasonography can be used to direct biopsies in specific regions of the prostate with a high cancer detection rate.

Methods: In 39 surgical cases of prostate cancer with 10 years of follow-up, we have tested a new monoclonal antibody that can recognize HPV E7 protein. Its specificity was detected in prostate lesions at the IHC level with the pre-absorption of the antigen. After the DNA extraction HPV-L1 gene was detected, confirming the virus persisting genome. The positivity was compared with clinical, follow-up data and ki67 positivity.

37 Near-total gland ablation of locally confined low- and intermediate-risk prostate cancer using Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS)

Results: We have found a positivity for HPV E7 in 63% of prostate cancer cases and this positivity was both nuclear and cytoplasmic with any kind of possible association. We divided the cases according to the usual clinical parameters that showed how prostate capsule infiltration, Gleason grading and nuclear grading were related to recurrences. Recently it has been put into evidence that ki67 is the best marker of prognosis available for prostate carcinoma. We confirm this hypothesis because all the cases with a ki67 positivity over 10% recurred. We compared all this clinical and pathological data with the nuclear and cytoplasmic positivity for HPV E7. We observed that nuclear positivity was mostly associated to low nuclear degree (G1) tumours and that cytoplasmic positivity was related to high ki67 positivity.

Desai S, Patil A, Raina S. Radiology, Jaslok Hospital and Research Centre, Mumbai, India Introduction: In May 2010, the Jaslok Hospital and Research Centre, Mumbai, India has installed an ExAblate Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS) multiapplication platform (InSightec, Tirat Carmel, Israel) in the 1.5T GE (General Electric) MRI suite. The MRgFUS platform includes also an investigational ExAblate 2100 Device for Prostate which comprises an endorectal focused ultrasound transducer. Like in other applications, the HDTX MRI provides high resolution anatomical visualization for accurate definition of desired treatment margins, and real-time

Conclusions: This first study of HPV E7 detection, in a limited number of cases of prostate cancer with long follow-up, has 16


temperature monitoring allowing case-dependent adjustment and customization of the therapeutic dose during treatment, for maximal safety and effectiveness.

volumes were less than 40 cc and PSA levels were between 5 to 15 ng/ml before treatment. Cancerous foci were invisible on screening multifunctional MRI scans in all 5 patients. Neurovascular bundles were bilaterally preserved in the treatment of the 2 young patients, unilaterally preserved in treatment of 1 patient. These patients reported pre-treatment good erectile function.

Locally confined prostate cancer is frequently an indolent disease which is currently being frequently overtreated by various radical treatment modalities involving a significant complication rate and long-lasting morbidity. Due to the severity of therapeutic adverse events and morbidity from one hand and the frequent relatively low risk for disease progression, many patients are reluctant to undergo definitive treatments and instead they remain under active surveillance. However, active surveillance involves significant psychological and financial burden, as well as some risk for undetected cancer progression. Thus, focal or near-total gland ablation may offer to patients with low- and intermediate-risk prostate cancer a middle ground solution in which, the prostate tissue suspected to bear cancerous foci is ablated, while functional structures like rectum, urethral sphincters, bladder wall, and potentially the neurovascular bundles, are preserved.

Due to movements that occurred during treatment, the treatment of 1 of the elderly patients was interrupted before completion of ablating the prostate base. Due to the patientâ&#x20AC;&#x2122;s age the urologist deferred the decision regarding completing the treatment in a second session, to follow-up PSA results. No adverse events occurred during or after treatments. Since the urethra was included in these treatments, patients remained with the suprapubic catheter until they were able to urinate spontaneously without residual urinary volume seen on ultrasound examination. In all the patients the suprapubic catheters were removed between 3 to 5 weeks. No incontinence was reported.

Up to date, 5 near-total gland ablation MRgFUS treatments were performed in our hospital for low- and intermediate-risk prostate cancer patients, with proven locally confined disease.

At 6 weeks of follow-up, PSA levels dropped from baseline of 5 to 15 ng/ml to 1 to 3.8 ng/ml in all the 5 patients.

Materials & Methods: Treatments were performed in the Jaslok Hospital and Research Centre as part of an industrialsponsored, IRB-approved prospective single-arm phase I trial.

Conclusions: Near-total gland ablation using Magnetic Resonance Guided Focused Ultrasound seems like a potentially safe minimally-invasive therapeutic alternative for young potent or elderly patients with low- and intermediate-risk prostate cancer, for whom surgery, cryoablation or radiotherapy might be aggressive and mutilating, however more data need to be obtained.

In the study were included patients aged 50 years or older with low-risk or intermediate-risk organ-confined prostate cancer, diagnosed by 12-core TRUS-guided endorectal biopsy; up to Gleason score of 7=3+4 (not 4+3 and no 5 scores); PSA <15 ng/ dl and no contraindications to MRI; maximum prostate gland volume was not greater than 40 cc. Patients should also be eligible for epidural or general anesthesia and willing and able to give consent and attend all study visits as defined in the protocol. Patients with prostatic calcifications near the rectal wall, or with any previous therapeutic anal, rectal, or prostatic interventions, as well as patients with contraindications for anesthesia, were excluded.

Abstracts accepted for poster presentation

The primary endpoints of the protocol are treatment safety and initial effectiveness in terms of disease-free survival measured by post-treatment stable PSA nadir levels and negative biopsy results.

38 Pooled analysis of two protocols of intermittent hormonal therapy in advanced prostate cancer

Pre-treatment evaluation included medical history, physical examination, PSA level, CT scan, multifunctional MRI, and TRUS-guided prostate biopsies of 12 cores. The patientâ&#x20AC;&#x2122;s urological and sexual baseline functional status was assessed, using the Expanded Prostate Cancer Index Composite questionnaire (EPIC-AUASI-SF12, 2002).

Brausi M1, Gonçalves F2, Kliment J3, Queimadelos M4, Calais da Silva FE5, Robertson C6. 1Urology, S.Agostino Institute, Modena, Italy; 2Urology, Klinika LFUH, Bratislava, Slovakia; 3Urology, Jessenius school of Medicine, Martin, Slovakia; 4Urology, Policlinica LaRosaleda, S.Compostela, Spain; 5Urology, H.Desterro, Lisbon, Portugal; 6 Statistics, University of Strathclyde, Edibourg, United Kingdom

Treatments were conducted after a minimum duration of 6 weeks post-biopsy. Treatments were performed in the MR suite using the ExAblate 2100 Prostate system and the GE 1.5T HDXT MRI.

Background & Objectives: Few randomized studies have compared intermittent hormonal therapy with continuous therapy for the treatment of advanced prostate cancer. We present pooled results from two randomized trials, with similar protocols and identical data collection. The objective is to compare overall and cause specific survival in patients receiving intermittent therapy compared to those receiving continuous therapy.

Patients underwent pre-treatment bowel preparation to avoid fecal residue in the rectum during treatment. Treatments were performed under epidural anesthesia with conscious sedation, and with a suprapubic catheter constantly draining the bladder. Post-treatment follow-up includes, 1 week, and 1, 3 6, 9, 12, 18 and 24 months visits; periodic PSA levels measurements; posttherapeutic function assessments using the EPIC-AUASI-SF12 questionnaire; multifunctional MRI scans at 6 and 24 months of follow-up and repeated prostate biopsies at 24 months of followup or earlier, based on PSA rise.

Materials & Methods: In MAB 626 patients (aged 50-88, mean=73) were randomized; 314 to continuous therapy and 312 to intermittent therapy. In CAB 917 patients (aged 44-91, mean=72) have been randomized; 462 to intermittent therapy and 455 to continuous. The statistical analysis was through a pooled individual level meta analysis with interaction tests to assess the constancy of treatment comparisons across studies. Cox proportional hazard models are used to investigate the effect

Preliminary initial results: By now we treated under this study protocol 5 patients with low- and intermediate-risk prostate cancer. All the patients were in the age group 50 to 85 yrs. All prostate 17


of treatment (intermittent therapy compared to continuous) on time from randomization until death. In a prognostic factor analysis the effects of age, T category, metastatic status, Gleason score and PSA at randomization are investigated. Interaction tests are used to assess if the effects of these prognostic factors are the same in the two studies.

39 Rectal toxicity 7 years after high-dose radiation for prostate cancer: clinical and dosimetric predictors Rancati T 1, Fellin G2, Fiorino C3, Vavassori V4, Cagna E5, Mauro FA6, Gabriele P7, Valdagni R8. 1Prostate Cancer Program, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; 2Radiation Oncology, Ospedale Santa Chiara, Trento, Italy; 3 Medical Physics, Istituto Scientifico San Raffaele, Milan, Italy; 4Radiation Oncology, Humanitas - Gavazzeni, Bergamo, Italy; 5Radiation Oncology, Ospedale Sant’Anna, Como, Italy; 6Radiation Oncology, Ospedale Villa Maria Cecilia, Lugo di Romagna, Italy; 7Radiation Oncology, Institute for Cancer Research and Treatment, Candiolo, Italy; 8Prostate Cancer Program and Radiation Oncology 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

MAB patients received cyproterone acetate (CPA) 200 mg for 2 weeks and then monthly depot injections of a LhRH analogue plus 200 mg of CPA daily during induction. Patients randomized to the intermittent arm ceased treatment while those randomized to the continuous arm received 200 mg of CPA daily plus a LhRH analogue. Patients randomized to the intermittent, received when on treatment 300 mg CPA and the continuous arm the same reduction treatment. Results: The median time on study for patients in the MAB trial was 57 months and for the CAB study 54 months. There are a total of 4213 person years at risk on CAB; these are equally split between the two treatments arms, 3514 years for continuous and 3586 for intermittent. There are differences between the two studies in terms of the patients recruited. In MAB there are more older patients, more T4, more M1, more G3, more Gleason 8+, and more with higher PSA at randomization. PSA at randomization was a design issue and to be randomized on CAB, PSA had to be less than 4 ng/ml. A total of 474 patients are known to have died in the MAB study and 421 in the CAB study.

Purpose: To evaluate long-term prevalence of late rectal bleeding (lrb) and of late fecal incontinence (linc) after high-dose radiotherapy (RT) in prostate cancer patients (pts) accrued in a prospective trial (RT doses: 70-80Gy,1.8-2Gy/fr) and to model the relationship between lrb/linc and clinical/dosimetric factors. Materials & Methods: Self-reported questionnaires (qs) of 515 pts with a minimum follow up of 6 yrs (median 7 yrs) were analyzed with respect to lbr and linc. Correlation between pre-treatment morbidities, hormonal therapy, drug prescription, presence of diabetes or hypertension, abdominal surgery prior to RT, presence of acute toxicity, pelvic nodes and seminal vesicles irradiation, mean rectal dose, dosevolume histograms constraints (from V20Gy to V75Gy) and lrb/ linc was investigated by logistic analyses.

Overall survival There is no evidence that the effect of intermittent therapy on overall survival was different in the two studies, p=0,25 and pooling the data is appropriate. Survival in the CAB study is better than in the MAB, p<0,0001 with a hazard ratio (HR) of 0,64 (95% CI 0,56 to 0,72). This can probably be explained by a better selection of patients for inclusion in CAB – lower PSA and less metastatic. There are no differences in overall survival, adjusting for study as the death rate in CAB is lower than in MAB, p=0,077 with HR 0,98 (95% CI 0,86 to 1,12).

347/515 pts had at least 3 toxicity (tox) qs in the first 3 yrs after the end of RT. Correlation between the mean score of linc in the first 3 yrs and linc at 7 yrs was also investigated. Results: 32 G1, 2 G2 and 3 G3 lrb were registered. 50 G1, 3 G2 and 3 G3 linc were reported. Lrb was only correlated to V75Gy (continuous variable, p=0.02, OR=1.07).

Cause specific survival In MAB 51% of deaths were due to cancer and 28% due to CVD, with 21% other causes, while in CAB 36% of deaths were cancer deaths and 46% CVD and 19% other causes. In both studies there are fewer CVD deaths in the intermittent arm, HR 0,87 (95% CI 0,70 to 1,09), p=0,22. While in MAB, in particular, there are more cancer deaths in the intermittent arm, HR 1,29 (95% CI 0,00 to 1,65), p=0,054 but not in CAB, HR 0,98 (95% CI 0,71 to 1,34), p=0,90. Overall the hazard of death from other causes was lower in the intermittent arm HR 0,83 (95% CI 0,62 to 1,12), p=0,23. There is no statistical evidence of differential effects in the two studies with regard to CVD (p=0,58) and cancer deaths (p=0,16) and other causes (p=0,33).

The prevalence of lrb ≥1 at 7 yrs was significantly correlated with the incidence of G2-G3 lrb in the first 3 yrs after RT treatment: 42% in pts with G2-G3 lrb in the first 3 yrs vs 6% in non-lrb pts (p<0.0001). Linc was correlated to multiple variables. In multivariable analysis (overall p<0.0001, AUC=0.77) V40Gy (continuous variable, p=0.09, OR=1.015), use of antihypertensives (protective factors, p=0.005, OR=0.38), presence of abdominal surgery before RT (p=0.004, OR=4.7), presence of haemorrhoids (p=0.008, OR=2.6) and presence of G2-G3 acute incontinence (p=0.007, OR=4.4) resulted to be correlated to linc.

Prognostic factor

Linc at 7 yrs was also correlated to the mean incontinence scores in the first 3 yrs (p<0.0001): pts without linc at 7 yrs had a mean score of 0.1 during the first 3 yrs, while pts with G1 and with G2G3 linc at 7 yrs had a mean score of 0.5 and 0.78 during the first 3 yrs, respectively.

Metastatic status, high Gleason score, older age and higher PSA are all associated with poorer survival. There is no evidence that the effects of the prognostic factors varied over the two studies p=0,53. Adjusting for these the HR of death from any cause in CAB is 0,81 (95% CI 0,70 to 0,94), p<0,01. This is still significant so these prognostic factors do not explain all the differences in survival between MAB and CAB. Adjusting for the prognostic factors there is still no evidence of any difference between intermittent and continuous therapy with a HR of 0,99 (95% CI 0,87 to 1,14), p=0,99.

Conclusions: A fraction of pts is still experiencing rectal tox symptoms 7 yrs after RT: 7% lrb and 11% linc. Prevalence of tox at 7 yrs is significantly correlated to incidence in the first 3 yrs after RT, this is an indication of a chronicization of symptoms, with linc playing the major role. Mean score for incontinence during the first 36 mos after RT can be used as a surrogate endpoint for >6 yrs linc.

Conclusions: Intermittent therapy should be considered for use in routine practice since it is associated with no reduction in survival, no clinically meaningful impairment in quality of life, better sexual activity and considerable economic benefit to individual and community. 18


currently tPSA cut-off values have not been determined for each ethnic group and thus large randomised studies are needed in order to determine the appropriate PSA values to decide upon the necessity for prostate biopsy.

40 Histopathological characteristics and post mortem PSA values of elderly Greek males with non cancerous prostates. The preliminary results of an autopsy study

41

Stamatiou K 1, Pierris N1, Skolarikos A 2. 1Urology, Tzaneio Hospital, Pireas, Greece; 2 Urology, Sismanogleio Hospital, Athens, Greece

For preoperatively potent men, low free testosterone (FT) is a significant predictor of potency return versus total testosterone (TT) levels in robot-assisted radical prostatectomy (RARP)

Introduction: The introduction and common use of serum PSA (Prostate Specific Antigen) has been demonstrated a useful index for prostate cancer diagnosis but in the same time has increased the number of unnecessary prostate biopsies. In fact, PSA levels alone do not provide enough information to distinguish between benign prostate conditions and cancer. Age-specific reference ranges have been proposed to increase the specificity and positive predictive value of PSA testing for detecting early prostate cancer and thus to decrease the number of unnecessary prostate biopsies. Since benign prostatic hyperplasia (BPH) is a very common condition, the mean normal PSA per age group in a certain population should be dependent on the incidence and degree of BPH. Moreover, since significant differences in mean PSA by race were found, age-specific PSA values as described by Oesterling et al., are probably not suitable for all populations.

Ahlering T, Osann K, Chang A, Morales B, Skarecky D. Urology, University of California Medical Center, Orange, CA, United States Purpose: We examined testosterone (T) and FT levels following RARP to see if lowered levels correlated with postoperative recovery of sexual function. Methods: Prospective data was entered for men undergoing RARP by a single surgeon. Recent postoperative T levels (N=154) and SHBG were used to calculate FT (N=204). The study group included potent men of all ages (40-78 years) only with preoperative IIEF-5 scores of 22-25. Postoperative potency was defined as 2 affirmative answers to “erections adequate for penetration” and “were the erections satisfactory” using self administered validated questionnaires. Men with FT ≤5.1 (LowFT, N=43) were compared to men with FT ≥5.1 (NormalFT, N=161) and to men with TT.

Aim: The aim of the study is to investigate the histopathological characteristics of non cancerous prostates of elderly Greek males and to correlate them with post mortem PSA values. Materials & Methods: Data were obtained from 120 autopsy specimens of the prostate gland and sera of men aged above 60 and under 98 years of age, born and living in Greece, who died (between 8/2010 and 4/2011) of causes other than carcinoma of the prostate. Cases found with macroscopic foci of carcinoma, cases suspected of a history of prostate cancer and putrefacted cadavers were excluded from the study.

Results: Table 1 presents pertinent pre and postoperative findings. Patient group characteristics were very similar except for men with LowFT and TT <300 which were significantly older. The NormalFT group had a minimum 2-fold increased rate of recovery across the 2 year followup, p ≤.02. TT <300 and >300 were not significant in predicting potency return throughout 24 M, all p =NS.

The whole prostate and seminal vesicles were removed with accuracy. The specimens were weighted, and examined macroscopically. The surface of the 2 lobes was colored in different colors and fixed in acetic acid. A 10% solution of formalin was injected uniformly per cm3 into the gland and the specimen was then immersed in formalin solution allowed to fix for 3 days. Base and apex were also removed by transversal sections and the slices were cut at 4 mm intervals. Specimens were divided and step-sectioned at 4 mm intervals perpendicular to the long axis of the gland. Pieces were post fixed, re-sectioned, dehydrated, cleared in xylene, embedded in paraffin, and stained with haematoxilin–eosin stain. The microscopy slides were numbered, registered and examined by an expert pathologist.

Conclusions: Interestingly we did not find that TT <300 or LowFT predicted lower baseline characteristics. Men with LowFT in distinction to TT <300 levels had statistically diminished return of potency. This data suggests that independently of patient characteristics and surgical technique, LowFT likely contributes postoperative impotence a minimum 2 fold. TABLE 1 N Age Preoperative PSA AUA Bother IIEF-5 BMI Prostate weight Postoperative PDE-5 qD* (Mos.) Ave follow-up TT Potent 3 M 9M 15 M 24 M

Results: Histological BPH was the more common lesion of the prostate gland among our study population, however, medium prostates (25-50 cc) were more frequent than large prostates (>50 cc). More than half of the examined prostates had evidence of histological non specific prostatitis. Prostate atrophy was rare however was by far more frequent in the prostates of elderly men (age groups 80-89 and >90). The mean post mortem PSA value for the age group 70-79 was 3.324, the mean post mortem PSA value for the age group 80-89 was 3.73 and the mean post mortem PSA value for the age group >90 was 2.88. Conclusions: Our reduced sample does not stand any statistic analysis, but these observations highlight the fact that a given PSA value may have a different clinical meaning for patients of different races and nations. This is of outmost importance given that screening rates for prostate cancer by serum PSA testing appear to be higher in men older than 70 years and especially for the southern European countries where people enjoy one of the highest life expectancies worldwide. To our knowledge, 19

LowFT NormalFT pvalue 26 91 63.5 58.5 ≤.01

TT <300 51 61.4

TT >300 103 58.7

pvalue

5.8 8.4 1.5 23.8 27.3 53.2

5.1 8.1 1.4 24.2 27.0 52.2

.35 .97 .96 .11 .81 .78

5.8 7.6 1.4 23.9 27.9 52.9

5.8 8.1 1.4 24.1 26.9 51.2

.95 .63 .77 .32 .39 .56

7.8

7.1

.65

6.9

8.0

.46

26.7 254 (4%) (17%) (18%) (33%)

22.9 400 (24%) (46%) (55%) (73%)

.33 ≤.01 .024 .015 .003 .003

25.7 231 (11%) (27%) (27%) (47%)

22.6 453 (22%) (41%) (45%) (61%)

.30 ≤.01 .10 .13 .07 .21

.02


rebuilding to reverse the preprostatectomy anatomical structure. In this study, we retrospectively analyzed the affecting factors for the postoperative urinary continence recovery after RARP.

42 Incorporation and economic impact of robotic surgery within a community hospital and healthcare system

Materials & Methods: This study included consecutive 100 patients with prostate cancer treated with bilateral nerve-sparing radical prostatectomy between 2008 and 2011. All patients had preoperative functional and oncological data available, including age at surgery, body mass index, prostate specific antigen, and erectile and urinary function. Also, operative data consisted of nerve-sparing status, estimated blood loss (EBL), and operative duration. Median operative time and EBL were 191 minutes and 200 mL, respectively. Out of 100, nerve-sparing procedure was applied in 64 (64.0%) for unilateral and 20 (20.0%) for bilateral. Urinary continence was defined as wearing less than one pad, just for safety. Univariate and multivariate Cox regression models were applied to test the association between factors and urinary continence recovery after surgery.

Laungani RG. Urology, Piedmont Hospital, Atlanta, GA, United States Introduction & Objectives: Healthcare in the US is a topic of major debate and has come under relentless scrutiny as of recent. Robotic surgery, due to its decreased morbidity, may have a major cost saving impact to both hospitals and healthcare systems. Community hospitals have shown the largest growth in regard to purchase of robotic systems but have realized the pitfalls of robotic surgery including the expense related to purchase, maintenance, and training of physicians. We discovered important points for incorporation of robotic surgery within a community hospital which translate into a significant reduction in costs for the hospital system as well as decreased charges for the healthcare system.

Results: At a mean postoperative followup of 12.5 months (range 3 to 32) 97 patients (97.0%) had recovered urinary continence. Overall urinary continence recovery rate at 1, 3, 6 and 12 month post RARP was 50.0, 83.0, 94.0, and 98.0%, respectively. On univariate analysis patient age and the nervesparing status were significantly associated with urinary continence recovery, p=0.048 and p=0.020, respectively. On multivariate Cox regression analysis, the nerve-sparing procedure, including unilateral and bilateral, was demonstrated to be the only independent predictor of urinary continence recovery after RARP.

Methods: A retrospective review of radical prostatectomy cases from 2004 to 2009 was conducted. This represented the time period before and after the adoption of robotics into the hospital system. Data related to hospital costs, charges per case, patient hospital stay and number of cases was reviewed. Results: With the introduction of robotics into the hospital system in 2006 we noticed an initial increase in cost and charges per case; $16,495 for open radical prostatectomy vs $25,593 for robotic prostatectomy. Cost and charges significantly decreased after 2 years and continued to decrease to below that for open radical prostatectomy; $14,481 for robotic prostatectomy in 2009. Average savings per case was $2911 with mean annual savings of $262,000. Case volume significantly increased from 39 open radical prostatectomies in 2004 to 269 robotic prostatectomies in 2009. Patient length of stay (days) decreased significantly from 2.72 to 1.08. This equates to 460 patient days saved for robotic radical prostatectomy compared to open radical prostatectomy. Urologists who are fellowship trained in robotics translate into a large case volume experience with no separate training or learning curve required. Increased case volume resulted in decreased costs and charges per patient after a period of 2 years compared to that of open radical prostatectomy.

Conclusions: Nerve-sparing procedure might affect the pelvic vascular as well as synthetic nerve function, which may affect the condition of external urinary sphincter, leading to early urinary continence recovery.

Conclusions: In the US, a large percentage of robotic growth has occurred in the community hospital setting. Investment in a robotic surgical system can be a daunting and expensive task for a community hospital, but we have found that over a period of 1-2 years benefits can extend to a community hospital and healthcare system in the form of overall decreased costs, decreased charges, more efficient care and excellent patient outcomes.

44 43

Detection, localization and exclusion of high grade prostate cancer with multiparametric MRI: correlation with radical prostatectomy histopathology

Nerve-sparing impacts on early recovery of postoperative urinary continence in patients treated with total urinary reconstruction on robot-assisted radical prostatectomy

De Visschere PJ1, De Potter A 2, Villeirs G1. 1Radiology, Ghent University Hospital, Ghent, Belgium; 2Pathology, Ghent University Hospital, Ghent, Belgium

Shiroki R , Maruyama T , Kusaka M , Fukami N , Fukaya K , Ishise H , Sasaki H , Hoshinaga K 2. 1Urology, Fujita Health University School of Medicine, Nagoya, Aichi, Japan; 2Urology, Fujita Health University, Nagoya, Aichi, Japan 1

2

2

2

2

2

2

Purpose: To determine the value of multiparametric MRI (mpMRI) for the detection, localization and exclusion of high grade prostate cancer (Gleason 4+3 or higher) in patients with elevated serum PSA.

Introduction & Objectives: The association between surgical procedure and urinary continence recovery after robot-assisted radical prostatectomy (RARP) remains controversial. Our RARP procedure consisted of ultradissection of bladder neck without opening the endopelvic fascia and total urinary reconstruction, comprising posterior (Rocco stitch), anterior, and lateral

Materials & Methods: 29 patients (mean age 62 years, range 52-71) with mean PSA of 12.2 ng/ml (range 4.8-36.0 ng/ml) underwent mpMRI followed by radical prostatectomy (within mean 54 days, range 2-194 days). mpMRI was performed on a 20


Conclusions: Hemi-salvage HIFU is efficient in patients with unilateral radio-recurrent PCa with a preserved Qol. It may offer comparable cancer control to whole gland treatment.

1.5T scanner with endorectal coil and included T2-weighted imaging, diffusion-weighted imaging and spectroscopic imaging. The peripheral zone was divided into 18 segments, and MRI findings were correlated to whole mount histopathology. Results: In total 522 segments were histopathologically evaluated. No tumor was found in 356 segments, low grade prostate cancer (Gleason 3+4 or lower) in 130 segments and high grade prostate cancer (Gleason 4+3 or higher) in 36 segments. Sensitivity, specificity and accuracy of mpMRI for the detection and localization of segments with high grade prostate cancer were 77.8%, 84.6% and 84.1% respectively. The negative predictive value for excluding high grade cancer was 98.1%.

46 The choice of active surveillance from the patients’ perspective Bellardita L1, Magnani T 1, Marenghi C1, Catania S1, Rancati T 1, Salvioni R2, Valdagni R3. 1 Prostate Cancer Program, Fondazione IRCCS Istituto Nazionale dei Tumori Milano, Milano, Italy; 2Urology, Fondazione IRCCS Istituto Nazionale dei Tumori Milano, Milano, Italy; 3Prostate Cancer Program, Radiation Oncology 1, Fondazione IRCCS Istituto Nazionale dei Tumori Milano, Milano, Italy

Conclusions: mpMRI in a subset of patients with elevated PSA with radical prostatectomy correlation (i.e. excluding nonsurgical indications) allows detection and localization of high grade prostate cancer, but has a higher value in the exclusion of high grade prostate cancer.

Introduction: Active surveillance (AS) for the management of low risk prostate cancer is benefiting from an emerging consensus from medical professionals. It is still debated whether the choice of such an option could be positively accepted by patients given the emotional burden brought about by the word “cancer”. The aim of this study is to report patients’ motivations and perceived advantages/disadvantages when electing AS.

45 Hemi-salvage HIFU in patients with radiorecurrent prostate cancer

Methods: Between September 2007 and March 2012, 167 patients enrolled in AS were administered self-report questionnaires, including a structured interview aimed to collect patients’ personal history, and to investigate the reasons for choosing AS. We report here results related to the following questions: 1. Why did you choose AS? (Patients could select more than one option) 2. Is there anyone who influenced your choice? If yes, who? 3. What are the advantages of AS? 4. What are the disadvantages of AS?

Baco E1, Crouzet S2, Rud E3, Rouviere O4, Chapelon JY5, Berge V 1, Gelet A6. 1Urology, Oslo University Hospital, Aker, Oslo, Norway; 2Hospices Civils de Lyon, Urology and Transplantation3, E. Herriot Hospital, Lyon, France; 3Radiology, Oslo University Hospital, Aker, Oslo, Norway; 4Radiology, Hospices Civils de Lyon, E. Herriot Hospital, Lyon, France; 5INSERM, Lab. TAU Inserm, Unit 1032, Université de Lyon4, Lyon, France; 6 Hospices Civils de Lyon, Urology and Transplantation3, E. Herriot Hospital, Lyon, FranceLyon, France Introduction: One third of patients treated with external beam radiation therapy (EBRT) for localized prostate cancer (PCa) experience local recurrence. Salvage treatment options include prostatectomy, cryoablation, and high intensity focused ultrasound (HIFU). Whole gland treatment in these patients offers acceptable cancer control, but carries a risk of severe urinary incontinence and reduction of QoL. In patients with unilateral local relapse, focal HIFU is feasible. The aim of this prospective study was to evaluate the effect of Hemi HIFU in patients with unilateral recurrence after EBRT.

Results: Patients’ mean age was 67. Patients answered to question 1 as follows: a) I trusted what the physicians told me 75%, b) I trust this Cancer Center 62%, c) I am comforted and satisfied by participating in a protocol 25%, d) I trusted what other people told me 10%, e) To avoid side effects of the therapies and maintain my quality of life 66%, f) I do not trust active therapies 3%, g) I found scientific papers about AS 14%, h) Medical checks are frequent 33%, i) It is a reversible option 48%. Influence on the choice of AS (question 2) was reported as follows: a) General practitioner 2%, b) Cancer Center 22%, c) Family 4%, d) Other physicians 18%, e) Other 10%. On the other hand, 44% of the patients reported that no one had influenced their choice. Advantages of choosing AS were reported as: frequent checks 24%, avoiding surgery 41%, avoiding side effects of the therapies 18%, maintaining QoL 9%, reversibility of choice 6%, clinical research 2%. Disadvantages of choosing AS were: frequent checks 4%, recurrence of biopsy 3%, anxiety 12%, fear for disease progression 22%, distance from Cancer Center 2%, none 57%. Only one patient reported medical checks as scarce and thus as a disadvantage.

Materials & Methods: Between 2009 and 2011, 43 patients were prospectively included in 2 centers. Inclusion criteria were positive MRI and biopsy in 1 lobe diagnosing unilateral cancer after EBRT (41 pts) and after brachytherapy (2 pts). Median age was 69 years (51-78), pre-HIFU PSA was 5.19 ng/mL (3.476.91) and Gleason score was 7 (≤7: 28, ≥8: 10, ND 7). Mean follow-up was 12 months. HIFU treatment was performed with Ablatherm®. Results: The mean PSA nadir was 0.77 (0.51-1.04). Control biopsies (in 12 pts with rising PSA) were negative in 75% (n=9) and positive in 25% (n=3): in the treated lobe: 2, in the contralateral lobe: 1.

Conclusions: Patients in our study cohort emphasized the importance of trust toward clinicians that proposed AS alongside self-motivation. One of the implications for clinical practice of these data is the emphasis that should be given to doctor-patient relationship given the complex decision making and uncertainty underlying AS.

Disease progression ocurred in 10 pts (23%): local recurrence: 3 pts, metastasis: 4 pts and rising PSA without local recurrence or proven metastasis in 3 pts. Five patients received androgen deprivation and 1 redo-HIFU. Severe incontinence occurred in 7% (n=3). The mean ICS score before/after treatment were score A: 0.51±0.27 / 2.30±0.59 and score B: 0.37±0.18 / 1.9±0.46. No significant change of EORTC-C 30 QoL and IPSS scores were observed: QLC30 35.07±8.57 VS 34.56±9.98; IPSS: 7.07±5.77 VS 8.84±5.72. The IIEF5 score decreased from 11.89±8.64 to 7.66±6.62.

21


A Bayer HealthCare-supported symposium during the 2012 Global Congress on Prostate Cancer

CRPC with bone metastases:

survival benefit with new-generation therapies

Friday 29 June 2012 17.45â&#x20AC;&#x201C;18.45 The Egg, Brussels, Belgium Auditorium 1 Bayer Pharma AG 13342 Berlin, Germany www.bayerpharma.com

G.SM.ON.06.2012.0417


CRPC with bone metastases: survival benefit with new-generation therapies | A Bayer HealthCare-supported symposium during the 2012 Global Congress on Prostate Cancer

CRPC with bone metastases:

survival benefit with new-generation therapies

program Welcome and Introduction Karim Fizazi, Institut Gustave Roussy, France

Approved Treatment Options Metastatic CRPC Axel Heidenreich, RWTH University Aachen, Germany

Targeting Metastases: Unmet Needs Neal Shore, Carolina Urologic Research Centre, USA

Recent Data and Ongoing Trials in Metastatic CRPC Chris Parker, The Royal Marsden NHS Foundation Trust, UK

Questions and Answers Conclusion and Summary

17.45–17.55 17.55–18.10 18.10–18.25 18.25–18.40 18.40–18.45

All faculty

Friday 29 June 2012 17.45–18.45 The Egg, Brussels, Belgium Auditorium 1

G.SM.ON.06.2012.0417


ng cr ui ti Re

Radium-223 Dichloride in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases—Expanded Access Program1

Expanded Access Program Trial Design • Population: Patients diagnosed with castrate-resistant (hormone-refractory) prostate cancer and bone metastases

Expanded Access Program for Radium-223 Dichloride TREATMENT PHASE

FOLLOW-UP PHASE

6 injections at 4-week intervals

Assessments every 6 months until end of program

Radium-223 Dichloride* 50 kBq/kg

M0

M6

M12

M18

M24

MONTHS *Plus best standard of care.

Purpose • To provide Radium-223 Dichloride to CRPC/HRPC patients diagnosed with bone metastases • To collect short- and long-term safety data on Radium-223 Dichloride

Inclusion Criteria†:

Exclusion Criteria†:

• Age≥18 years • Histologically or cytologically confirmed prostate cancer • Patients diagnosed with progressive bone predominant metastatic CRPC/HRPC with at least 2 skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph-node-only metastasis is allowed) • Progressive disease is defined either by: – The appearance of new bone lesions. If progression is based on new lesion(s) on bone scan only without an increase in PSA, PSA values from 3 assessments within the last 6 months must be provided; OR – In the absence of new bone lesions by 2 consecutive increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥5 ng/mL • Life expectancy ≥6 months • ECOG PS of 0 to 2 • Adequate hematological, liver, and renal function – ANC ≥1.5 x109/L – Platelet count ≥100 x109/L – Hemoglobin ≥10.0 g/dL (100 g/L; 6.2 mmol/L) – Total bilirubin level ≤1.5 x institutional ULN – AST and ALT ≤2.5 x ULN – Creatinine ≤1.5 x ULN – Albumin >25 g/L

• Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up • Eligible for first course of docetaxel (ie, patients who are fit enough, willing, and who are located where treatment with docetaxel is available) • Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted) • Received previous radiotherapy to >25% of bone marrow, including hemibody radiation • Received systemic therapy with radionuclides (eg, strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 chloride) for the treatment of bony metastases • Other malignancy treated within the last 3 years (except nonmelanoma skin cancer or low-grade superficial bladder cancer) • Visceral metastases as assessed by abdominal or pelvic CT (or other imaging modality) • Presence of brain metastases • Lymphadenopathy exceeding 6 cm in short-axis diameter • Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis • Imminent or history of spinal cord compression based on clinical findings and/or MRI • Any other serious illness or medical condition, such as but not limited to: – Any infection ≥NCI-CTCAE version 4.03 Grade 2 – Cardiac failure NYHA III or IV – Crohn’s disease or ulcerative colitis – Bone marrow dysplasia • Fecal incontinence

Radium-223 Dichloride is an investigational agent and is not approved by the US Food and Drug Administration, the European Medicines Agency, or other health authorities. Additional criteria apply.

Reference: 1. Bayer HealthCare Clinical Study Protocol BAY 88-8223/16216. Version 1.0; January 25, 2012. Abbreviation: CRPC=castration-resistant prostate cancer; HRPC=hormone-refractory prostate cancer; EBRT=external beam radiation therapy; PSA=prostate-specific antigen; ECOG PS=Eastern Cooperative Oncology Group Performance Status; ANC=absolute neutrophil count; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; AEs=adverse events; CT=computed tomography; MRI=magnetic resonance imaging; NCI-CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; NYHA=New York Heart Association

Bayer Pharma AG 13342 Berlin, Germany www.bayerpharma.com

G.SM.ON.06.2012.0419

04/12


Radium-223 Dichloride: an innovative, bone-targeted anti-tumor agent

Targets to bone1,2 • Radium-223 has calcium-mimicking properties, and hence: – It is a natural bone seeker – It targets areas of new bone formation in and around metastases – It is incorporated into the bony matrix

A highly localized effect1,2 • Alpha-particles have a very short track length of <100 µm (2-10 cell diameters) • Hence, damage to surrounding healthy tissue is minimized • By contrast, beta-particles produce low-energy radiation and a track length of several millimeters—leading to a higher likelihood of irradiating normal cells

Cancer cells

Osteoblasts

Radium-223 Dichloride

Osteoclasts

Highly localized cell-killing effect of Radium-223 Dichloride

Radium-223 Dichloride is an investigational agent and is not approved by the US Food and Drug Administration, the European Medicines Agency, or other health authorities. References: 1. Henriksen G, Breistøl K, Bruland ØS, Fodstad Ø, Larsen RH. Significant antitumor effect from bone-seeking, α-particle-emitting 223Ra demonstrated in an experimental skeletal metastases model. Cancer Res. 2002;62(11):3120-3125. 2. Nilsson S, Larsen RH, Fosså SD, et al. First clinical experience with α-emitting radium-223 in the treatment of skeletal metastases. Clin Cancer Res. 2005;11(12):4451-4459.

Bayer Pharma AG 13342 Berlin, Germany www.bayerpharma.com G.SM.ON.06.2012.0419

9/11


47

48

Predictors of upgrading/upsizing after 1-year re-biopsy in men participating in a prospective active surveillance program

Transperineal sector biopsies: their role in active surveillance Chang RTM, Popert R, Vyas L, Kinsella J, Challacombe B, Cahill D. Urology, Guy’s Hospital, London, United Kingdom

Nicolai N1, Alvisi MF2, Rancati T2, Colecchia M3, Salvioni R1, Villa S4, Bedini N , Biasoni D1, Marenghi C2, Avuzzi B 4, Paolini B3, Magnani T2, Catania S2, Valdagni R2,4. 1Urology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; 2Prostate Cancer Program, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; 3 Anatomopathology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; 4 Radiation Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Introduction & Objectives: Many men with low risk prostate cancer on transrectal biopsy appear suitable for active surveillance (AS). Under staging and grading at diagnosis can result in delayed treatment and risk of poorer oncological outcomes. In most AS series about 30% men have active treatment at a median of 2 years for presumed disease progression/choice but this may represent disease mischaracterised at initial biopsy. So it is essential to accurately stratify patients before surveillance. We have routinely offered transperineal sector prostate biopsies (TPSB), using 24-32 cores, to all patients considering AS.

Introduction: Since 2005, we have been proposing active surveillance (AS) in selected low-risk prostate cancer (PCa) pts. AS protocols include repeat biopsy at pre-defined follow-up intervals. We here consider the outcome of the first re-biopsy (1 yr after AS beginning) and analyse its possible correlation with diagnosis variables.

Materials & Methods: 350 patients with apparent low to intermediate risk prostate cancer after transrectal prostate biopsy (TRUS Bx) underwent TPSB.

Methods: Age, iPSA, PSA density, number of positive cores, % of positive cores, max and average core length containing cancer, number of negative cores at diagnosis, total number of cores at diagnosis, total number of cores at 1-yr re-biopsy, prostate volume, DRE were considered as factors potentially influencing upgrading (UPG)/upsizing (UPS). GPS was not considered (all pts had GPS=3+3).

Results: Median age 64 yrs (38-84). Median PSA 7.2 ug/l (0.1458). 190 had Gleason 3+3, 115 had Gleason 3+4 and 45 >3+4 disease. 145 (41%) patients elected for definitive treatment, in 112 because there was an upgrade or higher disease volume compared with the original TRUS Bx. 33 patients chose definitive treatment rather than continued AS. 205 (59%) patients entered our AS programme, in 25 follow up data is incomplete leaving 180 for analysis. 61 have had repeat TPSB within our protocol and at a median follow up at 2 years in 56/61 (92%) the Gleason score and volume of disease was unchanged. Only 5/180, 2.8%, have had treatment for disease progression and additionally 4/180 (2.2%) have chosen active intervention over continued surveillance, despite no evidence of progression.

Three separate endpoints were considered: (1) UPS OR UPG; (2) UPG and (3) UPS. Multivariable logistic regression (MVLR) was used to analyse correlations between variables and endpoints at first re-biopsy. Results: Statistical analysis was performed on 255 pts with complete records (1 yr min follow-up). 40% of pts had a negative 1-yr biopsy (0 positive cores), 45 pts had UPS/UPG after re-biopsy, switching to radical treatment.

Conclusions: TRUS biopsies under-estimate Gleason grade or cancer volume compared with TPSB. In our cohort of AS patients only 2.8%, at a median follow up of 2 years, have transferred to definitive treatment for disease progression. TPSB provides the best method to exclude higher risk disease from AS programmes.

MVLR resulted in a 2-variable model for endpoint “UPS OR UPG” (p=0.02, AUC=0.63): number of negative cores >5 (OR=0.43, p=0.19) and prostate volume >60cc (OR=0.27, p=0.04). When UPG (27 pts) was considered separately a 3-variable model was determined (p=0.018, AUC=0.71): age >60yrs (OR=3.4, p=0.12), PSA density (continuous variable, OR=1.04, p=0.16) and prostate volume >60cc (OR=0.17, p=0.1).

49 Impact of body mass index on the operative course and complications of robot assisted laparoscopic prostatectomy (RALP)

Taking UPS (18 pts) as the endpoint, MLVR resulted in a 5-variable model (p=0.03, AUC=0.73) including: DRE (T2a vs T1c, OR=3.03, p=0.16), number of negative cores >5 (OR=0.32, p=0.30), total number of cores at 1-yr re-biopsy (discrete variable, OR=1.14, p=0.18), age >60yrs (OR=0.48, p=0.23) and max core length containing cancer >10% (OR=3.4, p=0.03).

Rambaran SS1, Kliffen M2, van den Ouden D1, de Lange DCD1, Engel RP1, Klaver OS1. 1 Urology, Maasstad ziekenhuis, Rotterdam, Netherlands; 2Pathology, Maasstad ziekenhuis, Rotterdam, Netherlands

Conclusions: UPS is strongly related to “volume” variables, and, as a consequence, may be strongly affected by sampling. UPG is more related to PSA density. It is noteworthy as age has an opposite effect on the two endpoints (protective for UPS and risk factor for UPG) and that max core length containing cancer is highly predictive of UPS.

Objectives: To determine if obesity is associated with prolonged surgery or more complications during and after surgery and different oncological and functional outcomes in patients undergoing RALP. Patients & Methods: We evaluated 425 patients who underwent RALP between January 2009 and March 2011, performed in our hospital by the same surgical team. Patients had a mean BMI of 26,7 kg/m2 (15,5 - 42). Patients were categorized as normal weight (BMI <25 kg/m2, n=81), overweight (BMI 25 - 29,9 kg/ m2, n=254) and obese (BMI ≥30 kg/m2, n=90). Intraoperative parameters evaluated were console time and estimated blood loss. Postoperative parameters evaluated were pathological T-stadium, positive surgical margin status (PSM), postoperative Gleason score, biochemical recurrence (BCR), prostate volume, postoperative complications, length of hospital stay, continence

Such analysis may generate the hypothesis that two different populations of PCa pts are subjected to drop-off from AS protocols. Biological and clinical implications deserve further studies. Supported by Fond Monzino

26


Conclusions: A significant percentage of patients eligible for active surveillance showed a pathological aggressive profile. The selection of eligible patients should be careful while awaiting the results of clinical trials and new diagnostic tools that enable better understanding of tumor aggressiveness.

rate and potency rate. PSA progression (PSA ≥0.2) was used as a surrogate endpoint of progression. Functional outcome was measured using the ICIQ and the use of pads and the SHIM. Only preoperative potent patients who underwent bilateral nerve sparing were included in the analysis of potency outcomes. Results: Overweight and obese patients had longer mean operative times (132 and 144,7 vs. 122,3 min, resp; p<0,01). Mean estimated blood loss was not significant between groups (320,4 and 392 vs. 259 cc, resp; p=0,871). Overweight and obese patients were not significantly associated with an increased pathological T-stage (T2a 15,4%, T2a 16,7% vs. T2a 17,3%; T2c 54,3%, T2c 62,2% vs. T2c 49,4%; T3a 16,1%, T3a 10% vs. T3a 19,8%; T3b 12,6%, T3b 11,1% vs. T3b 12,3%, resp; p=0,0847), PSM (54/254 (21,3%), 21/90 (23,3%) vs. 18/81 (22,2%), resp; p=0,376), postoperative Gleason score (p=0,946), BCR (43/243 (17,7%), 18/103 (17,5%) vs. 8/79 (10,1%), resp; p=0,264), prostate volume (54,1 and 62,2 vs. 49,3 g, resp; p=0,204) and postoperative complications (17/254 (7%), 8/90 (8,9%) vs. 8/81 patients (9,9%), resp; p=0,10) compared to normal weight patients. Length of hospital stay was significantly longer in overweight and obese patients (3,5 and 3,8 vs. 3,3 days, resp; p<0,01) compared to normal weight patients. Return of continence at 1 year was not significantly different between groups; 38/41 (92,7%), 115/119 (96,6%) vs. 23/26 (88,5%) resp; p=0.384. Potency rate was significantly better in the normal weight group, compared to the overweight and obese patients; 15/21 (71,4%), 17/30 (56,7%) and 5/10 (50%) resp; p<0,01.

51 Extended pelvic lymph node dissection can enhance survival in prostate cancer patients with minimal lymph node invasion Alekseev BY, Nyushko KM, Andrianov AN, Vorobyev NV. Urology, Moscow Hertzen Oncology Institute, Moscow, Russian Federation Aim & Objectives: To assess biochemical recurrent-free survival (RFS) in intermediate and high risk prostate cancer (PC) patients after radical prostatectomy (RPE) with extended pelvic lymph node dissection (E-PLND) in subject to number of lymph node (LN) metastases revealed. Materials & Methods: Retrospective analysis of a database from 595 patients after RPE and PLND since 2006 till 2011 in our institution was performed. 262 consecutive PC patients with intermediate and high risk, who had undergone RPE with E-PLND, were included in the study. Patients with extensive LN metastases who received adjuvant hormonal treatment were excluded from the analysis. Mean patient’s age was 67.8±6.47 (46-77) years; mean PSA level 14.8±10.7 (1.5-79.0) ng/ml. Mean number of LN removed was 24.96±7.6 (15-52). Morphological stage pT2a-T2c was verified in 146 (55.7%) patients, pT3a-T4 – in 116 (44.3%). pN0 was found in 199 (76.0%); 1 or 2 LN metastases were found in 34 (12.9%); > 2 – in 29 (11.1%) patients. Morphological Gleason score 2-4 was in 3 (1.1%) patients, 5-6 – in 129 (49.2%), 7 – in 100 (38.2%), 8-10 – in 24 (9.2%) patients. In 6 (2.3%) patients Gleason score was not assessed. Median follow-up (FU) time was 21.4±15.4 (6-73) months.

Conclusions: RALP is a safe and effective procedure regardless of BMI. There is a slight increase in operative time and length of hospital stay compared to patients with normal weight, whereas pathological T-stage, PSM, postoperative Gleason score, BCR, complications rates, estimated blood loss and return of continence were not significantly different. Normal weight patients have a better potency rate compared to overweight and obese patients. Further long-term follow up with more patients is required to verify this initial observation.

Results: During FU period recurrences were observed in 74 (28.2%) patients. Recurrences were diagnosed in 33 (16.6%), 17 (50%) and 24 (82.6%) patients with pN0, with 1-2 LN metastases and with > 2 metastases respectively (p<0.05). Cumulative 2-year RFS was 85.4±3%; 44.96±10.7% and 22.6±8.5% in groups respectively (p<0.0001). Morphological stage, Gleason score and PSA level correlated with probability of PSA relapse after operation (p<0.0001).

50 Pathologic findings in patients undergoing radical prostatectomy in candidates for active surveillance Calleja-Escudero J, Calvo-Gonzalez R, Valsero-Herguedas E, Pascual-Fernandez A, Bedate-Nuñez M, Pesquera-Ortega L, Cortiñas-González JR. Urology, University Clinic Hospital, Valladolid, Spain

Conclusions: RFS significantly differed in groups of patients with no metastases, 1-2 metastases and > 2 metastases revealed. 2-year RFS rate in patients with 1-2 LN metastases was 45%, thus this patients could be candidates for delayed hormonal treatment.

Objectives: The number of patients with prostate cancer and low tumor burden has led to consider active surveillance as an option for treatment. This strategy aims to reduce the overtreatment, although the selection of these patients is challenging. We analyzed the clinical and pathological findings of radical prostatectomies performed in patient candidates for active surveillance according to NCCN criteria.

52 Prostate-specific antigen nadir and time to prostatespecific antigen nadir following maximal androgen blockade independently predict the prognosis in patients with metastatic prostate cancer

Methods: Between 2004 and 2011 we performed 324 radical prostatectomies from which 36 (11%) met the NCCN criteria for active surveillance, which are PSA <10 ng/ml, T1c, PSA density <0.15 ng/ml/g, Gleason score ≤6 and <3 positive prostate biopsy cores and ≤50% cancer in each core. We analyzed the correlation of histological data.

Kim SJ, Hong SY, Cho DS, Kim S, Ahn HS. Urology, Ajou University School of Medicine, Suwon, Republic of Korea

Results: The mean age was 62 years and the mean PSA was 5.45 ng/ml. 21 patients had a previous biopsy and 18 affected a single core. Radical prostatectomy Gleason score was 7 in 19 (52.7%) patients and in 1 no tumor was found. In 24 cases (66.6%) the tumor involvement was greater than in the biopsy in terms of bilateral.

Objectives: The aim of this study was to evaluate the influence of prostate-specific antigen (PSA) kinetics following maximal androgen blockade (MAB) on the disease progression and cancerspecific survival in patients with metastatic, hormone sensitive prostate cancer. 27


Methods: One hundred thirty-one patients with metastatic, hormone sensitive prostate cancer treated with MAB (combination of LHRH agonists or bilateral orchiectomy and antiandrogen) at our institution were included in this study. The median age of the patients at MAB initiation was 72 years (range, 49-92 years). Patients’ characteristics, PSA at MAB initiation, PSA nadir, TTN (time to PSA nadir), and PSA decline were analyzed by using univariate and multivariate analysis.

negative margins (61% vs 90% at 5 years, p<0.0005). Higher Gleason score was also significantly associated with shorter time to BCR (2-year BCRFS = 97% for Gleason ≤ 6, 81% for Gleason 7, and 43% for Gleason ≥ 8, p<0.0005). In multivariate analysis, pathologic stage, positive margin status, and Gleason score were independently associated with time to BCR after adjusting for age and pre-operative PSA. Hazard ratios (HRs) were 3.3 (95% CI: 1.7 - 6.4) and 4.8 (95% CI: 2.3 - 10.0) for stage 3A and 3B relative to stage 2. HRs with increasing Gleason score were 4.1 (95% CI: 1.7 - 10.3) for Gleason 7 and 11.4 (95% CI: 4.3 - 30.3) for Gleason ≥ 8 relative to Gleason ≤ 6. PSM was associated with a smaller increase in HR of 1.7 (95% CI: 1.1 - 2.9) after adjusting for all other factors.

Results: With a median follow-up of 30 months (range, 7-133 months), 97 patients (74.0%) showed disease progression and 65 patients (49.6%) died. Prostate cancer-specific deaths were 59 cases (45.0%). On univariate analysis, PSA at MAB initiation, PSA nadir, TTN, and PSA decline were significant predictors of progression-free survival. And PSA nadir, TTN, and PSA decline were significant predictors of cancer-specific survival. On multivariate analysis, higher PSA nadir (≥0.2 ng/ml) and shorter TTN (<8 months) were independent predictors of shorter progression-free and cancer-specific survivals. In the combined analysis of PSA nadir and TTN, patients with higher PSA nadir and shorter TTN had the worst progression-free survival (hazard ratio 14.098, p<0.001) and cancer-specific survival (hazard ratio 14.050, p<0.001) compared to those with lower PSA nadir and longer TTN.

Conclusions: Our data demonstrate the independent role of stage, PSM and Gleason score for biochemical recurrence. Gleason score ≥ 8 is the strongest predictor for biochemical recurrence. Pathologic stage 3 and Gleason 7 were also associated with a 3- to 4-fold increased risk for BCR. PSM contributed an additional small increase in risk for BCR after adjusting for other factors. TABLE 1

Conclusions: Our results suggest that the higher PSA nadir level and shorter TTN following MAB are associated with the higher risk of disease progression and poor survival in patients with metastatic, hormone sensitive prostate cancer. Furthermore, these two variables have synergistic effect on the outcome.

Hazard ratio*

Lower 95% CI

Upper 95% CI

Pathological stage pT2

1.0

pT3A

3.3

1.7

6.4

pT3B

4.8

2.3

10.0

Gleason score

53 Predictors for biochemical recurrence in robot assisted radical prostatectomy

≤6

1.0

=7

4.1

1.7

10.3

≥8

11.4

4.3

30.3

1.1

2.9

Surgical margin

Ahlering T, Lusch A, Osann K, Liss M, Skarecky D. Urology, University of California Irvine, Orange, CA, United States Objectives: Positive surgical margins (PSM) in men undergoing radical prostatectomy are an independent predictor for biochemical recurrence (BCR). We analyzed the incidence, associated factors and time to BCR of patients with prostate cancer and PSM in our first 435 robotic assisted radical prostatectomies.

Negative

1.0

Positive

1.7

54 Survival, Continence and Potency (SCP) outcomes 5-years after robot-assisted radical prostatectomy

Materials & Methods: The study cohort consisted of 435 consecutive patients undergoing RARP between June 2002 and August 2006. All surgeries were performed by a single surgeon (TA). Pre-operative PSA, positive margin status, pathological Gleason grade, pathological stage were identified. Three patients were lost to follow-up and 4 others (2 pT0 and 2 pT4) were excluded from analyses. Results included 428 patients with pathological stage 2 (n=311), 3A (n=92) or 3B (n=25). No patient had secondary therapy until documented BCR. BCR was defined as a serum prostate specific antigen level ≥ 0.2ng/ml with a confirmatory value or the date of any treatment intervention: hormonal, radiation or chemotherapy. BCR-free survival (BCRFS) was investigated using Kaplan-Meier methods and Cox Proportional Hazards Regression.

Ficarra V, Suardi N, Borghesi M, Bardelli I, De Naeyer G, Schatteman P, Carpentier P, Mottrie A. Urology, O.L.V. Robotic Surgery Institute and Urologic Clinic, Aalst, Belgium Objectives: To evaluate the oncological and functional outcomes 5-years after robot-assisted radical prostatectomy (RARP) using the new system Survival, Continence and Potency (SCP). Materials: Between 2003 and 2005, 184 consecutive patients with OC PCa received a RARP in our department. All patients were evaluated after a minimum follow-up of 5-year. Biochemical disease-free survival, continence and potency results were classified according to SCP system recently proposed in literature by Ficarra et al. In details, the S category is subdivided into three different groups: (1) patients treated with adjuvant therapies (Sx), (2) patients without PSA recurrence (S0), and (3) patients with PSA > 0.2 ng/ml (S1). The C category is subdivided into (1) patients not using a pad (C0), (2) patients using one pad for security (C1), and (3) patients using > 1 pad (C2). Cx category is used for patients who were not evaluable because of preoperative incontinence. P category is subdivided into (1) patients not evaluable (Px), (2) patients potent (SHIM > 17) without any aids (P0), and (3) patients potent (SHIM > 17) with erectile aids (P1) or patients impotent (SHIM < 17) (P2).

Results: The mean age ± standard deviation (SD) was 61.4 years ± 7.1. Sixty-seven patients (16%) experienced a BCR. Median time to recurrence was 18 months (range 0.5 months - 8.2 years). Median follow-up for those who did not have a BCR was 5.4 years (range 1 month - 9.1 years). 272 (63%) had ≥ 5 years follow-up; 391 (91%) had ≥ 2 years follow-up, 4 patients (1%) were lost to follow-up post surgery. BCRFS at 5 years was 94% for stage 2, 64% for stage 3A and 51% for stage 3B (log rank test, p<0.0005). Patients with PSM had lower BCRFS compared to those with

28


Results: All cases (185 pts) Sx= 24 (13%) S0= 143 (78%) S1= 16 (9%) Cx= 0 C0= 146 (79.2%) C1= 20 (10.9%) C2= 17 (9.3%)

Excluded Sx – Cx – Px (94 cases) S0= 88 (93.6%) S1= 6 (6.4%)

Px Patients Sx Excluded Sx Patients (65 cases) (24 cases) S0= 55 (84.6%) S1= 10 (15.4%)

C0= 82 (87.2%) C1= 8 (8.5%) C2= 4 (4.3%)

C0= 45 (70%) C1= 10 (15%) C2= 10 (15%)

Px= 73 (39.9%) P0= 48 (51%) P0= 52 (28.4%) P1= 34 (36%) P1= 41 (22.9%) P2= 12 (13%) P2= 17 (9.3%)

Our results suggest that BV and PS measurements, reflect angiogenesis and that perfusion CT with 64-row scanner is a feasible technique for assessing prostate cancer vascularization.

C0= 19 (79%) C1= 2 (8%) C2= 3 (13%)

Px= 8 (33%) P0= 4 (17%) P1= 7 (29%) P2= 5 (21%)

Conclusions: Our series shows the longest available follow-up in patients treated with RARP. Oncological and functional outcomes are very good also after a follow-up longer than 5 years.

56 High-intensity focused ultrasonography for treatment of localized prostate cancer: a mid-term follow-up

55

Siegel FP1, Ferber A 2, Egner T2, Schoen G2, Trojan L1, Schiefelbein F2, Heinrich E1. 1 Urology, UMM (University Medical Centre Mannheim), Mannheim, Germany; 2Urology, Missionsaerztliche Klinik, Wuerzburg, Germany

Prostate cancer angiogenesis: a preliminary experience with 64-row multidetector CT (MDCT) perfusion - do quantitative measurements distinguish tumor?

Objectives: To report on the mid-term functional and oncological outcomes, from 1 institution, of high-intensity focused ultrasound (HIFU) in the treatment of localized prostate cancer.

Pastore AL, Palleschi G, Petrozza V, Di Cristofano C, Rengo M, Osimani M, Laghi A, Carbone A. Sapienza University of Rome, Faculty of Pharmacy and Medicine, Department of medico-surgical Sciences and Biotechnologies, Urology Unit, Latina, Italy

Patients & Methods: A total of 151 patients with histology proven localized prostate cancer have been treated using the Ablatherm device. The mean follow-up including 96 patients was 36.4 months (range 12 to 55). Mean age was 73.8 years (range 51 to 89). According to D’Amico risk stratification 53.1% had a low, 37.5% an intermediate and 9.4% a high risk prostatic carcinoma. Biochemical failure was defined according to the Phoenix definition (PSA nadir + 2 ng/ml). Follow-up included PSA measurement, IPSS, DRE, post voiding residual urine, maximum urinary flow rate, TRUS and transrectal biopsy in case of biochemical failure or suspicious digital rectal examination.

Aim: To prospectively test the relationships between quantitative CT perfusion parameters and immunohistochemical microvascular density (MVD), considered as a gold standard marker of angiogenesis, in prostate cancer. Materials & Methods: The used study protocol conformed to the guidelines of the Declaration of Helsinki and each patient provided written consent in accordance with the requirements of our institutional review board. Between July 2009 and April 2010, twenty-one consecutive men (mean age, 59.7 years; age range, 48-71 years) were enrolled. All patients were examined with 64-row MDCT scanner for dynamic CT perfusion imaging, before prostatectomy surgery. Perfusion data sets were analyzed by the software (Prostate protocol, Perfusion 4.0). Values for each of the four perfusion CT parameters (blood volume (BV), blood flow (BF), mean transit time (MTT), permeability surfacearea product measurements (PS)) were recorded and correlated with MVD and mean vascular area (MVA) calculated from macrosection-correspondent areas.

Results: The median PSA nadir after HIFU therapy was 0.63 ng/ml (range 0 to 9.94). Median PSA at follow-up examination was 0.84 ng/ml. Biochemical failure was recognized in 23.9% of patients (low risk: 15.6%, intermediate risk: 31%, high risk 44.4%). Sextant biopsies in case of biochemical failure revealed 39.1% local recurrence. 34.8% developed metastatic disease and 26.1% of PSA elevations were without detectable reason. Intraoperative no major complications were noted. Three patients developed epididymitis and further 3 patients had mild abdominal pain after cystostomy removement. 15.8% underwent transurethral resection after HIFU because of bladder outlet obstruction. Two (2.1%) patients developed relapsing bladder neck sclerosis. Mean IPSS improved significantly from 10.25 to 8.6 (p=0.02). Six percent of patients reported stress incontinence using 1 pad during daytime, but no severe stress incontinence (grade 2 to 3) was observed. Better or unchanged quality of life was indicated by 77%.

Results: ANOVA analysis revealed more noticeable significant differences in BV, MTT and PS perfusion parameters (P<0.01). Two-tailed Spearman rank correlation analysis showed highest correlation level between BV and PS measurements of prostate cancer squares (respectively 0,618 and 0,614), while MTT was inversely correlated (-0,475). BV and PS showed highest area under the curve (AUC) value in ROC analysis (0,769 and 0,708). Discussion & Conclusions: This complex study design was fitted to investigate if CT was also a feasible technique in prostate cancer, and how CT perfusion parameters changed on the basis of vascularization of malignant or benign prostate lesions. Results were encouraging and, above all, statistically significant. In particular, we found there were significant differences in mean values of BV, MTT and PS parameters between benign lesions and malignant lesions as confirmed by other authors.

Conclusions: Our results confirm efficacy and low invasiveness of HIFU in the treatment of localized prostate cancer. Patients with low risk carcinomas are likely to be most suitable for efficient HIFU treatment.

29


Results: In 67% (180) of the cases, the biopsy showed a Gleason <7, in 31% (85) Gleason 7, and in 2% (5) Gleason >7. Of the prostatectomy specimens, 62% (162) were Gleason 7, 4% (10) Gleason >7, and in 8 no tumor was found. Comparing the Gleason biopsy with radical prostatectomy there was concordance in 56,5% (148). Laterality was concordant in 53% (139). Both Gleason and laterality was consistent only in 36% (94) of cases.

57 Treatment of primary tumor in patients with metastatic prostate cancer: an unanswered question Taylor D1, Collette L2, Berthold D1. 1Medical Oncology, CHUV, Lausanne, Switzerland; 2 Statistics, EORTC, Brussels, Belgium

Conclusions: Prostate biopsy underestimates the prostatectomy Gleason score in 36% (97) of the evaluated patients and overvalues it in 3% (8) of men.

Aim: Treatment of metastatic prostate cancer at diagnosis is androgen deprivation therapy (ADT). In that scenario, the treatment of the primary tumor in the absence of local symptoms is unnecessary as the main therapeutic goal is to temporarily control incurable disease with minimal toxicity.

59

Several trials have shown that increasing local control with combined radiotherapy (RT) and ADT in locally advanced prostate cancer has a favorable impact on survival. Our hypothesis is that the treatment of the primary tumor is important for the control of distant metastasis and therefore could improve outcome also in metastatic patients.

Early response in alkaline phosphatase as an independent predictive factor for disease progression in castration-resistant prostate cancer patients with post-chemotherapy PSA elevation Hong SJ, Han KS. Urology, Department of Urology, Yonsei University College of Medicine, Seoul, Republic of Korea

Methods: EORTC 22863 randomized study investigated the role of 3-year ADT combined with external pelvic RT vs. RT alone for locally advanced prostate cancer. Its data was recomputed in order to determine events according to time. The type of first recurrence, locoregional, distant or both were analysed.

Introduction & Objectives: Prostate-specific antigen (PSA) changes during the early phase of chemotherapy are known to be inaccurate surrogates for outcome in castration-resistant prostate cancer (CRPC). We investigated the potential value of serum markers related to skeletal metastasis as differentiating and/or surrogate biomarkers in CRPC patients.

Results: With a median follow-up of 10 years, in the group of patients treated with RT alone (n=208), 26 (12.5%) had as a first event a locoregional recurrence, 63 (30.3%) had distant recurrence and 14 (6.7%) experienced both. In the group treated with RT followed by 3 years of hormonal therapy (n=207), 9 (4.3%) had locoregional recurrence, 34 (16.4%) had distant recurrence and 1 (0.5%) had recurrence in both sites. Distant recurrence was in both groups the most important site for relapse.

Materials & Methods: We retrospectively reviewed 83 patients with CRPC who received chemotherapy from 2002 to 2008. Baseline levels and serial changes of serum PSA, alkaline phosphatase (ALP) and calcium were assessed. Pre-treatment clinical data and follow-up serum markers were also evaluated. We analyzed the relationship between serum markers and PSA flare and outcomes.

Interpretation: This data shows that androgen suppression reduces both local and distant recurrences when added to RT in locally advanced prostate cancer. We hypothesize that 3 years of ADT may not eradicate distant micro-metastatic lesions and thus cannot fully account for long-term disease control. We suggest that increased local control and therefore irradiation of the primary tumor could reduce the occurrence of macro-metastatic disease and therefore be beneficial on outcome. Factors from the primary tumor could induce a stimulus to dormant micro-metastasis and hence contribute to the development of distant lesions and poor outcome. This hypothesis can only be confirmed or rejected in a randomized trial for men with newly diagnosed metastatic prostate cancer.

Results: Of 61 patients, PSA initially increased in 33 patients (54.1%) and PSA flare occurred in 14 (22.9%). Of the 14 patients with PSA flare, the initial ALP increased in 2 (14.3%) and the initial calcium level increased in 5 (35.7%). In contrast, of the 19 patients with PSA progression, the initial ALP increased in 16 (84.2%) and calcium increased in 9 (47.4%). Multivariate analysis showed that only an initial change in ALP was associated with the occurrence of PSA flare. In addition, outcome analyses revealed that an initial increase in ALP and PSA were independently associated with disease progression, but only an initial change in ALP was a significant predictor for progression in patients with an initial increase in PSA. Conclusions: The early response in ALP level after chemotherapy is a differentiating marker between PSA flare and PSA progression and is an independent predictive marker for progression-free survival in CRPC patients with post-chemotherapy PSA elevation.

58 Correlation between the biopsy gleason and radical prostatectomy specimen

60

Calleja-Escudero J, Calvo-Gonzalez R, Valsero-Herguedas E, Pascual-Fernandez A, Bedate-Nuñez M, Pesquera-Ortega L, Cortiñas-González JR. Urology, University Clinic Hospital, Valladolid, Spain

Diagnosis of anterior prostate cancer using MRI/TRUS real time soft image fusion

Objectives: The Gleason score in prostate biopsy cores is important in decision making for prostate cancer. We evaluated the correlation between Gleason score on biopsy and prostatectomy specimen.

Baco E1, Rud E2, Svindland A3, Eggesbø HB 4. 1Urology, Oslo University Hospital, Aker, Oslo, Norway; 2Radiology, Oslo University Hospital, Aker, Oslo, Norway; 3Pathology, Oslo University Hospital, Radiumhospitalet, Oslo, Norway; 4Radiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway

Methods: We evaluated 324 prostates diagnosed with prostate adenocarcinoma from which 270 were valid for the study. The mean patient age was 61,3 years with an average ultrasound volume of 51,6 cc and PSA 9,34 (3,5-26) ng/ml. In 183 patients without previous biopsies and 4 with an average of 3 previous biopsies, digital rectal examination was normal in 54% of the cases.

Background: Anterior prostate cancers are rarely palpable and difficult to sample when using traditional transrectal ultrasound (TRUS) biopsies. Accurate targeted biopsies can be performed when using magnetic resonance imaging (MRI) and 3D TRUS 30


real time soft image fusion. The aim of the study was to evaluate the accuracy of MRI/TRUS guided biopsies in the detection of anterior prostate cancer.

seen in 75, 36 and 5 patients respectively. This left 69 patients (37.3%) that had no evidence of invasive malignancy in which 48 patients had entirely benign histology (26%). Anterior cancers were found in 38 patients (32.8%) and 17 patients (15.3%) had cancer completely confined to the anterior sectors only. Following the transperineal sector biopsies, 30 patients commenced active surveillance, 39 with low risk disease had dynamic brachytherapy, 30 had radical robotic prostatectomy and the remaining 17 patients had either hormones and/or external beam radiotherapy. 4 patients had retention of urine and 3 patients had haematuria requiring overnight stay. No urosepsis or urinary tract infections requiring antibiotics were observed.

Materials & Methods: Between 2010 and 2012, 358 patients with elevated prostate specific antigen (PSA) underwent MRI/ TRUS guided biopsies. 90/358 (25%) pts with MRI suspicious anterior cancer were included in the study. Biopsy patient groups were: initial biopsy 5 pts, 1st -10th re-biopsy 63 pts (mean previous negative biopsy procedures 2.6), re-biopsy due to active surveillance 19 pts, and PSA recurrence after radiotherapy 3 pts. Mean age, PSA and prostate volume were 65 years, 17.0 ng/ml and 42 ml. MRI: 1.5T Avanto (Siemens, Erlangen) and body array coil. Sequences: ax3D T2w, and DWI b2000 and b50/1000 were used for apparent diffusion coefficient (ADC). Ultrasound: 3D Accuvix V10 (Medison®, Korea), navigation system: Urostation (Koelis®, Grenoble, France). Minimum one biopsy was obtained from each MRI target using 18G Tru Core ®II (Angiothech, USA). One sample T- test was used for statistics.

Conclusions: Primary transperineal sector biopsies are safe, offer high cancer detection rates and aid treatment stratification.

Results: 74/90 (82%) pts had positive targeted biopsies with Gleason score 6 (n=25), 7 (n=34), 8 (n=14) and 9 (n=1), and mean tumour volume 3.2 ml (95% CI 1.6-4.8). ADC values for positive targeted biopsies were 78 x10-5mm2/s (95% CI 74-82) and for negative targeted biopsies 97 x10-5 mm2/s (95% CI 90-104), p<0.001. The mean number of positive targeted biopsies pr. patient was 2.7, and the mean length of cancer pr. biopsy was 5.5 mm.

62 Hospitalization itself decreases the serum prostate-specific antigen values compared to the outpatient values in patients with benign prostatic diseases Kim SJ, Yoon IS, Shin TY, Cho DS, Kim S, Choi JB, Ahn HS, Kim YS. Urology, Ajou University School of Medicine, Suwon, Republic of Korea

Conclusions: MRI/TRUS real time fusion biopsy technique is accurate in diagnosing anterior prostate cancer.

Objectives: There have been a few reports about the discrepancy between outpatient and inpatient serum prostatespecific antigen (PSA) values in the same man, addressing that the lack of activity associated with bed rest during hospitalization might decrease the serum PSA values. This study was performed to investigate whether the hospitalization itself may influence the serum PSA values.

61 Transperineal biopsies of the prostate as a primary modality for histological diagnosis

Methods: Transrectal ultrasound-guided prostate biopsies were performed for detecting prostate cancer in 2,017 patients between February 2001 and April 2011 at our institution. Among them, 416 patients were hospitalized for prostate biopsies and the serum PSA values were checked at outpatient department (OPD) within 1 month before admission and also just after admission, and the results of the prostate biopsies revealed no evidence of cancer. We retrospectively reviewed the data of the 416 patients and compared the serum PSA values checked at preadmission OPD and during hospitalization.

Chang RTM1, Popert R1, Vyas L1, Morris E1, Tsui M1, Yamamoto H1, Duasko S1, Meiers I2, Chandra A3, Challacombe B1, Cahill D1. 1Urology, Guy’s Hospital, London, United Kingdom; 2Pathology, Bostwick Laboratories, London, United Kingdom; 3Pathology, Guy’s Hospital, London, London, United Kingdom Introduction: Screening studies indicate that in patients undergoing primary transrectal sextant biopsies, 25% are positive for cancer. This figure increases to 45% in extended biopsy protocols, but there may still be under sampling of the anterior peripheral zone of the prostate. We evaluated transperineal sector biopsies (TPSB) of the prostate as a primary modality for gaining histological diagnosis within an asymptomatic cohort of patients who had undergone PSA testing as part of a company routine health screening assessment.

Results: Among a total of 416 patients, the interval between the 2 PSA measurements was 22.2 days (range, 3-30 days) and the prostate size measured by transrectal ultrasonography was 53.63 cc (range, 12.8-197.9 cc). Among a total of 416 patients, mean serum PSA levels checked during hospitalization were significantly lower than those checked at OPD (6.69 ng/ml vs. 8.01 ng/ml, p<0.001). When stratified according to age, the presence or absence of chronic prostatitis in biopsy pathology, serum PSA levels, and prostate size, the serum PSA levels checked during hospitalization were significantly lower than those checked at OPD in all subgroups, except in cases with age 20-39 years and PSA level less than 4 ng/ml, which showed no significant differences.

Patients & Methods: A total of 185 patients referred following a routine general health screening assessment were included in the study. The median age was 59 yrs and the median PSA was 6.10 ng/mL (range 0.7 - 182 ng/mL). The transperineal sector biopsies involved taking a total of 24 - 38 cores that were peripherally directed, were done as a daycase procedure under general anaesthetic without the need for catheterisation. We set out to evaluate the cancer detection rate, characteristics and location of cancers, clinical progress and complications.

Conclusions: Hospitalization itself decreases the serum PSA values compared to those checked at OPD in patient with benign prostatic diseases. Therefore, the serum PSA values should be checked on an OPD basis for the serial monitoring of PSA levels.

Results: 137 (74%) patients had abnormal histology comprising of acinar small cell proliferation (ASAP) (%), high grade prostatic intraepithelial neoplasia (HGPIN) (%) or adenocarcinoma. 116 patients (62.7%) had adenocarcinoma. Of these patients Gleason sums of 6, 7 and greater than 7 were 31


Materials & Methods: 94 pts were selected for analysis according to preoperative criteria of insignificant PCa. Mean age of patients was 62.3±6.4 (47-74) years. PSA level ranged from 1.1 to 10 ng/ml (mean – 6.8±2.2). Median percent of positive cores was 18.9±10.1% (7.7-33.3%). Clinical stage T1b was diagnosed in 6 (5.3%) pts, T1c – in 59 (52.7%) pts, T2a – in 47 (42.0%) pts.

63 Efficacy and tolerability of 3- and 6-month depot formulations of leuprorelin acetate for advanced prostate cancer in daily clinical practice: pooled data from 2 non-interventional studies

Results: The pathological stage pT0N0 was determined in 8 (7.1%) pts. After postoperative morphology 10 (8.9%) pts demonstrated upgrade of GS, upgrade of stage from localized to extracapsular and metastatic (pN+) disease was determined in 12 (10.0%) pts and 3 (2.7%) pts. Bilateral tumor extent was revealed in 63 (56.3%) pts. Clinical stage (p=0.9), number of biopsy cores (p=0.8), PSA level (p=0.5), body mass index (p=0.3), prostate volume (p=0.2) and biopsy GS (p=0.2) didn’t significantly correlate with probability of pathological upgrade of PCa.

Ohlmann CH1, Gross-Langenhoff M2, Tunn UW3. 1Department of Urology, Saarland University, Homburg/Saar, Germany; 2Medical Department, Astellas Pharma GmbH, Munich, Germany; 3Urological Department, Urological Clinic Fachartzentrum Klinikum Offenbach, Offenbach/Main, Germany Introduction & Objectives: Androgen-deprivation therapy is the current standard therapy for advanced prostate cancer (PCa). This therapy often consists of injections of luteinising-hormonereleasing-hormone (LHRH) agonists. The LHRH agonist leuprorelin acetate (LA) is available in several formulations, including 1-, 3- and 6-month biodegradable polymer matrix depot formulations (Eligard®), which have been shown to reduce testosterone and PSA levels in several clinical trials (Crawford ED et al. J Urol 2006;175:533-6/Perez-Marrero R et al. Clin Ther 2002;24:1902-14/Chu FM et al. J Urol 2002;168:1199-203). The current study aimed at monitoring efficacy and tolerability of these formulations in PCa patients seen in daily clinical practice.

Conclusions: The clinical criteria of low volume and low grade PCa are useful for selection of pts for ablative therapy because the rate of stage and grade upgrade after RPE was in our study only 23.3%. On the contrary these parameters are not suitable for prediction of only one lobe involvement (upgrade to bilateral extent was 69.6%) and can’t to be used in planning of unilateral ablative therapy.

Methods: Two prospective, open-label, non-interventional studies were conducted in Germany. 1,906 advanced PCa patients starting treatment with either the 3-month (22.5 mg) or the 6-month (45 mg) LA depot formulation (Eligard®) were followed during 12 months by 662 office-based urologists. Primary efficacy parameters total serum testosterone and PSA were measured at baseline and every 3 (for 22.5 mg dose) or 6 (for 45 mg dose) months until 12 months after treatment initiation. Physicians were also asked to rate ease of use and local tolerability of the treatment.

65 Prostate cancer gene 3 (PCA3) in postoperative prognosis after radical prostatectomy – initial experience Belej K, Kaplan O, Kohler O, Kocarek J, Chmelik F. Urology, Central Military Hospital, Prague, Czech Republic Introduction & Objectives: Current prognostic factors in prostate cancer (PC) patients before radical prostatectomy are not precise and they usually change in the majority of patients after surgery. There is a big afford to find new prognosticators which can predict results of procedure. More reliable parameters will allow proper use of all technical alternatives available – uni/bilateral nerve-sparing, bladder neck-sparing etc. Role of prostate cancer gene 3 (PCA3) was evaluated in a pilot prospective study.

Results: Median testosterone levels were reduced by 90% from 88.8 ng/dl to 8.9 ng/dl 12 months after treatment start. Testosterone reduction below the castration level was achieved both in treatment-naïve patients and in patients pretreated with LHRH agonists. Median serum PSA levels were reduced by 96% from 12.2 ng/ml to 0.5 ng/ml 12 months after treatment start. About 2/3rd of physicians found handling of the prefilled syringe (very) convenient, while >90% rated local tolerability as good or excellent. Adverse events (AEs) occurred in 8.8% of patients, with injection site pain and hot flushes being the most common ones.

Methods: Robotic-assisted extra-peritoneoscopic radical prostatectomy (RARP) was performed in consecutive patients with histologically proven PC. Patients indicated for surgery had T1-T3 (non-bulky) cancer and were eligible for general anesthesia with no other restriction according to other factors. Common prognostic factors (T stage, Gleason score (GS), PSA, number of positive cores, laterality, prostate volume) were evaluated. Commercial kit for PCA3 detection in urine (ProgensaTM, Gen-Probe Inc., USA) was added as new factor and its level in first catch urine after digital rectal examination of the prostate was displayed as PCA3 score (PCA3 mRNA and PSA mRNA ratio x 1000).

Conclusions: These data confirm that the 3- and 6-month LA depot formulations reduce testosterone and PSA levels to a similar extent in daily clinical practice as in clinical trials, both in treatment-naïve and in pretreated patients. This study also confirms the good tolerability of the 3- and 6-month LA depot formulations. The majority of physicians found handling of the prefilled syringe in routine clinical practice (very) convenient.

64

Results: In 76 patients with average age of 64 years (46-72 years) and average PSA level of 5.8 ng/ml (2.1-21.7 ng/ml), 51 of 75 (68 %) patients had localized PC (pT2) and 64 of 75 (85 %) men had GS ≤ 7. One patient had pT0 finding. PCA3 in urine was detectable in all but one patient (3rd in order) and no inconclusive result was found in evaluable men. PCA3 score didn´t correlate with prostate volume, serum PSA level and number of positive cores (p > 0.05). Significant correlation between pathological T stage (pT) and PCA3 was found. Other patholological factors (GS, laterality) were independent of PCA3 score.

Preoperative prognostic factors fail to predict one lobe involvement in patients with clinically insignificant prostate cancer Andrianov AN, Nyushko KM, Vorobyev NV, Alekseev BY. Urology, Moscow Hertzen Oncology Institute, Moscow, Russian Federation Objectives: The aim of the study was to assess pathological outcomes after radical prostatectomy (RPE) in pts with unilateral low volume and low grade PCa and evaluate prognostic significance of preoperative clinical parameters regarding postoperative tumor stage and grade. 32


Conclusions: Based on this pilot study PCA3 score can predict pT stage after radical prostatectomy and no other available factors were correlated with PCA3 level in urine. These preliminary results must be confirmed by larger study and multivariate analysis which can evaluate role of PCA3 more precisely.

67 Incidental carcinoma of the prostate (IPCa) in Kosovo Cuni Xh1, Haxhiu I1, Yusuf T 1, Cuni H1, Haxhiu A1, Xhani M2, Tartari F2, Bezhani E2. 1 Urology, University Hospital, Pristina, Kosovo; 2Urology, University Clinical Centre Mother Teresa, Tirana, Albania

Project was supported by Tomas Bata Foundation.

Introduction & Objectives: To determine the occurrence of incidental carcinoma of the prostate (IPCa), in a group of patients surgically treated (TURP and open adenoma enucleation) for BPE in Kosovo. Information on IPCa in Kosovo is lacking. The present investigation is first in Kosovo who was carried out to enlighten IPCa among the operated patients diagnosed by BPE in a 5-years cohort study.

66 Nurse practitioner-led telephone follow-up service for stable prostate cancer: patient satisfaction Turner B1, Tanabalan C1, Pati J1, Nargund V 1, Wells P2. 1Urology, Homerton University Hospital, London, United Kingdom; 2Clinical Oncology, Homerton University Hospital, London, United Kingdom

Materials & Methods: This is hospital-based cohort study conducted in Jan 2005-Dec 2010. The study comprised a retrospective analysis of 2430 patients. The preoperative variables analyzed were DRE, serum PSA value, and patient age. Preoperatively all 2430 patients involved in this study had a serum PSA value < or = 4.0 ng/mL without suspicious DRE and age > 50 years.

Introduction & Objectives: The telephone follow-up service is based on the premise that PSA measurement can be used as a surrogate for outpatient attendance with the core of the service being an approved and comprehensive protocol in which any break will trigger a medical referral. The telephone follow-up service has served to reduce the number of patients coming to the hospital for appointments. This has led to an increased clinic capacity and reduced waiting times, thus ensuring urgent care is available for patients who need it.

Results: Out of 2430 cases operated for BPE, 130 (5.3%) of all patients appeared to have IPCa. In all these cases the histological findings reported adenocarcinomas, grade I-III, Gleason score 2-6 and 7-10. 103 patients were diagnosed with a T1a tumour and 37 patients with a T1b tumour of prostate. Prostate adenocarcinoma identified by Gleason score: (G2-G6) were 65% (n = 90) of cases, and (G7-G10) were 35% (n = 40) of cases. The other 2300 patients had postoperatively a histopathological result of benign hyperplasia. The mean age among patients with IPCa was 73.9 ± 9.2 years, versus 69.0 ± 3.4 years among patients with BPE. The advanced age (P = 0.004) was statistically related to the findings of the surgical specimen analysis.

This report aims to address patients’ experience of a nurse-led, protocol-driven telephone follow-up service that was set up for men with ‘stable’ prostate cancer, to ensure that patient satisfaction and quality of care have been maintained. Materials & Methods: Questionnaires and stamped addressed envelopes were sent to all patients registered under the telephone follow-up service. The survey was voluntary and anonymous and patients were given 4 weeks to return the completed questionnaire. The questionnaire consists of 10 closed-ended questions and 1 open-ended question.

Discussion: The value of 5.3 % of patients with incidental prostate cancer can be explained by the population structure of Kosovo characterized as youngest population in Europe, where 60% of the population belongs to the age group of 25-35 years. From the present study we can conclude that the older the age of the patient with BPE is followed by greater possibility for IPCa. Incidental PCa may appear even in patients with normal preoperative serum PSA (value < or = 4.0 ng/mL), with no suspicious DRE and age >50 years.

Results: In total, 40 questionnaires were sent out, 29 were returned, yielding a response rate of 73%. Overall, the respondents reported high satisfaction with the telephone follow-up service (90% were either satisfied or very satisfied). In terms of the consultations themselves, the majority of patients found the length of the conversations to be ‘just right’ (93%) with a lesser majority expressing that the calls were always at times convenient to them (78%) and that they were always called when they were told they would be called (74%). Patients felt that the information given to them over the phone was always easy enough to understand (89%) and the majority felt that they always had the opportunity to ask questions during the conversations (81%). When asked whether they would prefer telephone follow-up or hospital follow-up, 79% of the respondents reported that they would prefer telephone followup, citing convenience, time and privacy as the reasons for their preference. 21% of patients would prefer hospital follow-up, reporting ease of understanding, not liking the telephone and preference for face to face contact.

68 Multidisciplinary, multiprofessional management of prostate cancer patients: is it really feasible? Magnani T 1, Salvioni R2, Villa S3, Bellardita L1, Nicolai N2, Procopio G4, Avuzzi B1, Bedini N3, Biasoni D2, Donegani S1, Rancati T 1, Marenghi C1, Stagni S2, Verzoni E4, Zaffaroni N5, Valdagni R1,3. 1Prostate Cancer Program, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; 2Urologic Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; 3Radiation Oncology 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; 4Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; 5Molecular Pharmacology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy Cancer patients are better managed in a multidisciplinary (MD) setting. It should be more so with prostate cancer (PC), which, depending on the risk class, has multiple therapeutic and observational options.

Conclusions: The telephone follow-up service relieves pressure on the Outpatient Department, increases capacity, reduces waiting times and brings care closer to home. This report also demonstrates that in general, patients perceive the service as a valuable addition to their care and report high levels of satisfaction with the service. It is worth noting, however, that a small number of patients reported a preference for hospital-based follow-up. It is recommended that patient preference is regularly assessed.

Our PC Programme was established in 2004 as a translational, MD and multiprofessional project. First steps: 1) to build a MD team with urologists, radiation 33


oncologists, medical oncologists, psychologists, palliative care experts, uropathologists and radiologists; 2) to share and adopt diagnostic and therapeutic guidelines; 3) to start a MD clinic (March 2005) organized in:

or death was delayed >7 months for degarelix vs leuprolide. In those with metastatic disease, there was better control of serum alkaline phosphatase with degarelix vs leuprolide (p=0.014), indicating that degarelix prolongs control of skeletal metastases. Improvements in quality of life global health status scores were also significant for degarelix vs leuprolide.

Friday clinic: urologist, radiation oncologist and psychologist (medical oncologist on demand) examine PC patients synchronously:

Effect on gonadotrophin-releasing hormone (GnRH) receptors: Differential effects of GnRH agonists and antagonists on the pituitary are well established (see below). Differential effects on peripheral GnRH receptors may also impact on clinical outcome.

Monday: case discussion (CC) to share the decisions taken on the MD cases, evaluate adherence to guidelines, perform quality checks on the MD working, discuss problematic cases on observation and complex cases seen monodisciplinarily.

Testosterone control: In CS21, degarelix led to an immediate, profound testosterone suppression, which was maintained during CS21A. In contrast, leuprolide caused an initial testosterone surge and subsequent microsurges. The importance of long-term testosterone suppression is increasingly recognised, eg high testosterone levels correlate with increased mortality risk in metastatic disease.

The MD team became multiprofessional by including professionals (project manager, secretary, data manager, nurse). From March 2005 to March 2012, 2760 MD clinics were performed. The organizational model was modified to better performance and service. Considering the high % of low-risk PC patients referring to the MD clinic of our Institution (61% in 2009) and included in active surveillance protocols (342 patients in Feb 2012), resources have been increased to better manage this sub-population and reduce the % of lost to follow up (2%).

Follicle-stimulating hormone (FSH) control: There was immediate and sustained FSH suppression in the degarelix group in CS21 and CS21A. With leuprolide, there was an initial increase in FSH and suppression, once achieved, was not maintained on the long term. After crossover from leuprolide, FSH decreased to levels seen with continuous degarelix. Interestingly, FSH stimulates growth of hormone-refractory PCa cell lines and in man, FSH levels are significantly higher in those with more advanced disease.

The low % of advanced and metastatic PC patients (5% in 2011) induced to organize the MD lists according to the risk class with the medical oncologist on demand. The efficacy of our MD clinic is demonstrated in the drug therapies prescribed outside our Institution and terminated by the MD team (11%). The efficacy of the CC is demonstrated in the % of indications formulated in the MD clinics and changed in the following CC (6%) as a result of quality checks of our own performance.

Conclusions: Degarelix improves PCa control vs leuprolide. This reflects differential effects on GnRH receptors and in turn, testosterone, FSH and PSA, all of which have prognostic significance in PCa.

The MD approach is proving successful. Strategies are agreed on, complex cases managed multidisciplinarily, responsibility on critical issues is shared and the psychologistsâ&#x20AC;&#x2122; insights help to consider the role of education-related and cultural factors in patientsâ&#x20AC;&#x2122; decisions. The CC discussion is fundamental to learn the MD working, create a shared MD know how and approach the patient as a subject of care rather than a disease to cure.

70 Transperineal sector biopsies (TPSB): the technique and morbidity Popert R, Chang RTM, Vyas L, Kinsella J, Cahill D. Urology, Guyâ&#x20AC;&#x2122;s Hospital, London, United Kingdom

Special thanks to Fond. ProADAMO and Fond. Monzino for their support

Introduction & Objectives: Transperineal (TP) mapping biopsies taking 40 - 90 cores are associated with urinary retention in 10 - 17% and are labour intensive. We report on a simplified transperineal sector biopsy (TPSB) protocol which we have incorporated into our active surveillance (AS) programme. We describe our technique and report our complication rates.

69 What are the mechanisms underlying the improved prostate cancer (PCa) control with degarelix compared to leuprolide?

Materials & Methods: The protocol was developed from our real time peripherally loaded brachytherapy technique. The prostate is divided into 6 - 8 sectors; right and left sides are subdivided into anterior, mid gland and posterior sectors with additional basal biopsies for glands larger than 30cc. Geographical 3D interpretation can be facilitated by placing individual cores from each sector on to sponges with the cores laid from medial to lateral (a - d). The most medial core (a) is inked at the basal end, allowing the pathologist to report on the medial to lateral and apico - basal distribution of the tumour (see diagram).

Van Poppel H1, Damber J-E2, Persson B-E3. 1Department of Urology, University Hospital Gasthuisberg, Leuven, Belgium; 2Department of Urology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; 3Ferring Pharmaceuticals, St-Prex, Switzerland Introduction: Degarelix and leuprolide were compared in a 1-year, randomised PCa study (CS21). In CS21A (long-term extension), leuprolide patients were crossed over to degarelix. Tumour control was more effective with degarelix vs leuprolide in these studies (see Van Poppel & Klotz, Int J Urol 2012, in press); here, we assess differences in their pharmacological profiles that could account for clinical differences.

Results: 775 patients with known or suspected have undergone TPSB. 205 patients have entered our AS programme, 247 patients have required active intervention, the remainder were benign and have been discharged to their primary physician. Complications include retention in 2% and haematuria requiring admission in 1%. Urosepsis requiring admission has not occurred although in 1% urine infections occurred, associated with bladder outflow obstruction.

Cancer control: In CS21, degarelix reduced prostate-specific antigen (PSA) significantly faster than leuprolide and led to a 34% improvement in PSA progression-free survival (PFS). After crossover from leuprolide to degarelix, PSA PFS improved from 0.2 to 0.08 events/year (p=0.003; 27.5-month follow-up). In patients with baseline PSA >20 ng/mL, time to progression 34


Conclusions: TPSB are safe with a better complication profile than more extended protocols. It allows more confident risk stratification of patients, particularly with regard to suitability for AS and the planning of active intervention. The 3D geographical information obtained can be used to optimise nerve sparing techniques in radical prostatectomy, provide preferential loading in brachytherapy and targeted treatments in focal therapy.

clinical situation permits, would minimise the risk of BRONJ by reducing anti-angiogenic effects of bisphosphonate. Long-term surveillance and maintenance of good oral and dental hygiene by dental practitioners or community dental services are paramount because the half life of bisphosphonate is up to 10 years as it is absorbed into hydroxyapatite within the jaw bones.

72 SOCS3-proteins seem to identify a subset of prostate cancer with more aggressive behavior. Immunohistochemical analysis in a cohort of patients affected by prostate cancer: preliminary result

71 Reducing the risks of bisphosphonate-related osteonecrosis of the jaw among metastatic cancer patients requiring IV bisphosphonates

Calarco AC1, Recupero SM1, Pinto F 1, Totaro A1, Pierconti F2, Martini M2, Bassi PF 1. 1 Urology, Catholic University School of Medicine “A. Gemelli” Hospital, Rome, Italy; 2 Pathology, Catholic University School of Medicine “A. Gemelli” Hospital, Rome, Italy

Tanabalan C1, Turner B1, Ali S1, Pati J1, Wells P2, Cheng L3, Ali E3, Nargund V4. 1Urology, Homerton University Hospital, London, United Kingdom; 2Clinical Oncology, Homerton University Hospital, London, United Kingdom; 3Maxillofacial Surgery, Homerton University Hospital, London, United Kingdom; 4Urology, Homerton University Hospital, London, United Kingdom

Background: Chronic inflammation may play a role in prostate carcinogenesis. Molecular alterations of the Suppressor of Cytokine Signaling (SOCS)-3 can contribute to explain the pleiotropic role of interleukin (IL)-6 in this type of cancer. Recently, the methylation of the SOCS3-gene was demonstrated to cause the non-expression of the protein, thereby highlighting its involvement in the pathogenesis of prostate cancer (PC) and enabling identification of a subset of aggressive tumors. We evaluated the expression of the SOCS3-protein in patients (pt) with bioptically-diagnosed PC by immunohistochemical analysis, something which is easier to perform, cheaper and more reproducible compared to the DNA analysis.

Introduction: Bone metastases are a common feature of advanced cancer and are associated with morbidity and mortality and are of particular concern in prostate and breast cancer due to the prevalence of these diseases. In addition to the immeasurable effect to the patient, skeletal-related events (SRE) are costly to health services in terms of patient encounters, resources utilization and cost. Each SRE is estimated to cost an average of £2000. Bisphosphonates have been used effectively for osteoporosis, some cancers and multiple myeloma by inhibiting bone turnover and osteoclastic function. The management of the rare but serious side effect bisphosphonate-related osteonecrosis of the jaw (BRONJ) is less well documented due to the lack of consensus or guidelines.

Methods: We analyzed the protein expression of SOCS3 by immunohistochemistry in 44 pt. Slides were incubated with monoclonal antibody SOCS3 (1E4, 1.5 μg/ml; Abnova,Taiwan). The SOCS3 staining intensity was evaluated by 2 pathologists (FP and LML) in 3 different ways: positive (+), negative (-) and weak (+/-). Colonic mucosa was used as positive control. 36/44 patients underwent radical prostatectomy (RP).

All patients with metastatic prostate and breast cancer requiring IV bisphosphonates are managed in our uro-oncology nurse practitioner-led bone support clinic.

Results: Biopsy Gleason score (Gs) was: <7 in 8 pt, 7 in 33 pt (3+4 pattern in 21 pt, 4+3 pattern in 12 pt), >7 in 3 pt. 8/8 (100%) pt with Gs <7 and 7/33 (21%) with Gs 7 were SOCS+. 15/33 (45%) pt with Gs 7 and 3/3 (100%) pt with Gs >7 were negative. In 11/33 pt (33%) Gs 7 a weak intensity was found so they were classified as SOCS3 +/-.

Aim: In order to avoid risks of BRONJ among cancer patients requiring bisphosphonates, we have arranged a fast track referral system to our Oral and Maxillofacial Surgery Department for oral assessment and atraumatic removal of dentition prior to the commencement of bisphosphonate therapy. Materials & Methods: The uro-oncology nurse practitioner leads a metastatic bone cancer clinic and faxes a fast track referral letter to the Maxillofacial surgery team. Clinical and radiological assessment of dentition is undertaken before bisphosphonate therapy begins. The necessary extraction or surgical removal of teeth/roots are carried out atraumatically and primary mucosal closure with resorbable sutures wherever it is possible.

25/36 (69%) pt who underwent RP were SOCS3- and 11/36 (30%) SOCS3+. 12/25 (48%) SOCS3- pt had an organ-confined disease (≤pT2), whereas 13/25 (52%) had an extraprostatic neoplasm (5 pT3a [1 was N+], 6 pT3b, 1 pT4). All SOCS3+ patients (11/11) had an organ-confined disease. 7/11 (63%) SOCS3+/- pt had an extraprostatic neoplasm (>pT2). Conclusions: SOCS3- pt turned out to have a more aggressive disease compared with SOCS3+. In particular, also SOCS3+/- pt tumors seemed to have an aggressive behavior.

Patients requiring dental restorations are referred to a dedicated community dental service.

The non-expression of the SOCS3-protein may identify prostate cancer with more aggressive behavior and can be evaluated with immunohystochemical analysis, which is a relatively easy and cheap procedure in clinical practice. These results, if confirmed in a wider population and with a longer follow-up, may encourage research on the use of this molecular family as a prognostic marker and a target for therapy with demethylating agents.

Results: 20 patients with metastatic cancers have been referred through the fast track system for oral/dental assessment. 5 patients were not referred as they did not have teeth. 19 patients required dental treatment before commencing treatment with bisphosphonates. None of our patients have developed symptoms of BRONJ. Conclusions: Early atraumatic removal of teeth/roots and primary mucosal closure to cover the healing alveolar bone before the start of bisphosphonate therapy are key to prevent the risk of BRONJ. For patients already started bisphosphonate treatment, the cessation of bisphosphonate for 3 months if the 35


Decisions & Outcomes: The calculus was endoscopically removed under general anesthesia revealing its nidus on a hemostatic clip. Patient symptoms resolved and he is clinically well, continent and has a PSA of 0.03 ng/mL.

73 Erectile function following robotic prostatectomy Warren MA, Issa R, Anderson C, Perry M. Urology, St George’s Hospital, London, United Kingdom

Conclusions: Laparoscopic radical prostatectomy is a technically demanding operation. To the best of our knowledge we report the first case of calculus formation around a hemostatic clip at the vesicourethral anastomosis after laparoscopic radical prostatectomy.

Introduction: The prevalence of erectile dysfunction following treatment for prostate cancer varies widely in the literature. This project assessed erectile function in patients following robotic prostatectomy at St George’s Hospital in London and investigated factors that may affect erectile function post-operatively. Methods: Questionnaires asking about urological symptoms were posted to 150 patients who had undergone robotic prostatectomy at St George’s more than 6 months previously. Erectile function was assessed using the IIEF-5, an internationally recognised and externally validated questionnaire. Responses were then compared to clinical features of each patient’s treatment and demographic factors. Pre-operative IIEF-5 scores were available for a sub-group of 62 patients who had taken part in a previous study and comparative analysis was also performed separately on this group to assess the relevance of baseline erectile function. Results: 105 completed questionnaires were returned (response rate 70%), of which 59% scored below 5 out of a maximum 25 for erectile function. Age, ethnicity and pre-operative erectile function were all significantly correlated with post-operative IIEF-5 scores. Patients receiving adjuvant treatment also had statistically worse erectile function than those who did not. Clinical features of the cancer itself such as stage, PSA level and prostate volume were not correlated with function postoperatively.

75

In multivariate analysis, age and black ethnicity remained significant determinants of post-operative erectile function. This remained the case for the sub-group with pre-operative IIEF-5 scores, which were also found to be a significant determinant of post-operative function in multivariate analysis.

Abiraterone acetate for castration-resistant prostate cancer following docetaxel: our initial experience

Conclusions: Assessing erectile function before surgery and taking a patient’s age and ethnicity into account can give a good indication of likely function after robotic prostatectomy. This is useful for the counselling of patients prior to surgery. Patients can also be advised that adjuvant treatment may further impact functional outcomes.

Introduction & Objectives: Abiraterone acetate is a novel systemic hormonal therapy for castration-resistant prostate cancer (CRPC) patients. It potently blocks cytochrome P450C17 (CYP17), a critical enzyme in testosterone synthesis, thus blocking androgen synthesis in the adrenal glands, testes and within the prostate tumour. We present our initial experience with abiraterone acetate, which was provided to our patients in a compassionate use programme.

74

Materials & Methods: During a 14-month period, abiraterone acetate (1 g, combined with 10 mg prednisone) was prescribed to 18 patients following docetaxel treatment. Data were collected retrospectively. Follow-up schedule was a 2-weekly visit during the first 2 months and thereafter monthly. Each visit included history taking, clinical examination and serum analysis (PSA, electrolytes and liver enzymes). Response was defined as a PSA decline of ≥ 50%, stable disease was a PSA decline of 0-50%, while progressive disease was defined as a rising PSA. Continuous values are expressed as mean (± standard deviation). Mean patient age was 70,8 years (± 6,4). Gleason score was 6 in 2 patients, 7 in 2 patients and ≥ 8 in 9 patients. In 5 patients Gleason score was unknown. Mean pre-treatment PSA level was 740,9 ng/ml (± 1681,9).

Van Praet C1, Lumen N1, Rottey S2. 1Urology, Ghent University Hospital, Ghent, Belgium; 2Oncology, Ghent University Hospital, Ghent, Belgium

Vesicourethral anastomosis lithiasis after laparoscopic radical prostatectomy Ramos R, Rebola J, Silva J, Carneiro R, Lencastre J, Silva E. Urology, Instituto Português de Oncologia, Lisboa, Portugal Introduction: Prostate cancer surgical treatment with laparoscopic radical prostatectomy is becoming more used for due to its non-inferiority to standard open technique in cancer control and rate of complications and superiority in terms of post-operative patient recovery. Vesicourethral anastomosis is one of the most demanding steps in this operation. Case description: We present the case of a 57-year-old man with the diagnosis of a Gleason 7 (3+4) prostate cancer. Intraperitoneal laparoscopic radical prostatectomy was performed and surgery was uneventful. Six weeks afterwards the patient started complaints of dysuria and frequency. Escherichia coli urinary tract infection was diagnosed and treated twice. Due to persistent symptoms an urethrocystoscopy was performed and a fixed calculus was identified at the urethrovesical anastomosis.

Results: Eleven out of 18 patients (61,1%) benefitted from treatment: 5 patients (27,8%) had a response, 6 (33,4%) had stable disease, while 7 (38,9%) had progressive disease. Using Kaplan-Meier survival curves, a median time to PSA or clinical progression of 6,3 months was seen in responders and 2,1 months in patients with stable disease. Mean duration of abiraterone acetate treatment in all patients was 2,8 months 36


(Âą 2,3). Recorded complications were elevated liver enzymes (4 patients), hypokalaemia (1), anorexia (3), nausea (1), myalgia (1) and diarrhoea (1). Until now treatment was aborted in 14 patients: due to biochemical or clinical progression in 12 patients, elevated liver enzymes (> 5 times) in 1 patient and 1 patient died during treatment.

9.4% of all cancers reported in Setif. The results suggest that prostate cancer ranked second among male population and the age-adjusted incidence rate increased quickly during these two decades.

Conclusions: In our first series of patients treated with abiraterone acetate, response or stable disease was recorded in 61% of patients with a median time to PSA or clinical progression of 6,3 months in responders. Complication rate was fairly low. These preliminary results tend to confirm the data from the COU-AA-301 trial.

77 The treatment of local advanced prostate cancer according to our experience Haxhiu I1, Quni Xh1, Hyseni S1, Aliu H1, Haxhiu A 2, Haxhiu E2. 1Urology, University Clinical Center of Kosovo, Prishtina, Kosovo; 2Medical Faculty, University of Prishtina, Prishtina, Kosovo

76

Introduction & Objectives: Prostate cancer develops primarily in men over fifty. Kosovo is the country with the youngest population in Europe, with over 50% of them under the age of 28, and this may be the reason why prostate cancer is the third most common cancer, after the bladder and kidney, in our Clinic, beside the fact that in the USA, Europe and many other countries around the world, prostate cancer is the second most common cancer in males, right after lung cancer. And of course we must not forget other factors that contribute to this situation too, which include the absence of health culture by our patients, the expensive diagnoses for them and also, the missing experience of our physicians.

Trends in prostate cancer incidence in Setif, Algeria between 1987-2007 Zoubida Z1, Djamel A 2, Aicha DD3, Abbes M1, Slimane L1, Mokhtar HC1. 1Cancer registry of Setif, University Hospital of Setif, Setif, Algeria; 2Anatomopathology, University Hospital of Setif, Setif, Algeria; 3Anticancer center of Constantine, University Hospital of Constantine, Constantine, Algeria Introduction: Prostate cancer is very common and while the incidence rate is rising quickly, in many countries, the mortality rate has started to fall. While aggressive testing with prostate specific antigen has contributed to this decline in mortality, urological cancers comprise approximately one third of all cancers diagnosed in men worldwide, and prostate cancer is the commonest of these. The global burden of prostate cancer rose from 200,000 new cases/year in 1975 to reach an estimated 700,000 new cases in 2002.

Our purpose was to give a full information about the incidence of prostate cancer in Kosovo, the methods of treatment, especially those for locally advanced prostate cancer, focusing more on radical prostatectomy as a favorable choice. Materials & Methods: This is a retrospective study. The material gives information about the incidence and the type of surgical intervention applied to the patients diagnosed with prostate cancer which were admitted to our Urological Center (the only tertiary center in Kosovo). 117 cases with prostate cancer were processed, considering their age, the Gleason score and the type of intervention. We have been more focused on monitoring and the course of disease of the patients with locally advanced prostate cancer.

In Algeria, in 2002, prostate cancer was the eleventh most common cancer in men with 466 cases (3.3%). Our study aimed for adjusting prostate cancer incidence trends over the longest period available (1987-2007) in Setif for the effect of age, sex, and period of diagnosis and the geographical distribution. These data were compared with standardized rates of Cancer Registries in Five Continents.

Results: 117 patients were processed, to which surgical intervention was applied, because of prostate cancer. We applied radical prostatectomy in 38 patients, orchiectomy in 53 patients (patients with advanced cancer), transvesical prostatectomy in 24 patients, only the biopsy in 1 patient and ureterocutaneostomy in 1 patient. Before these interventions the sextant biopsy was performed and the Gleason score ranged from 1-10. In 3 of them the Gleason score was 10, with infiltration of the seminal vesicles, and in 2 of them this score was 9. So it means that we dealt with T3c and T3a stages or with locally advanced prostate cancer. In 2 cases radical prostatectomy with orchiectomy was performed, and in the 3 other cases radical prostatectomy was performed with 2 cycles of Androcur. The course of the disease was followed for 2 years and it was seen that the first 2 cases had normal PSA levels within 2 months and there was no tendency for these values to increase. In 1 case, who was treated with Androcur, no evidence wa seen of an increased PSA level. In the 2 other cases treated with Androcur, the levels of PSA started to increase after 2 years. These 5 patients were told to make a CT of pelvic and abdomen, and since they turned out to be normal, we suggested them to have subcapsular orchiectomy, and 1 month after the intervention the levels of PSA were normal.

Materials & Methods: Incidence data were collected in the period 1987-2007 from the population-based cancer registry of Setif. The software used was the Can Reg 4 produced by the unit of descriptive epidemiology of the International Agency for Research on Cancer (IARC), Lyon. France. Cancer morphology and topography were coded in accordance to the International Classification of Diseases for Oncology manual (ICD-O, the third edition). Results: In Setif, prostate cancer ranked second among the male population. The incidence was highest among men in the 80-82 age group (51.7%) followed by men in the 60-64 (30%) and the 75-79 (16.3%) age group. The median age at diagnosis was the 65-69 age group.

Cases

1987-1989

1993-1997

2002-2007

25

71

192

%

3.7

5.2

9.4

ASR

2.9

4.3

8.2

(ASR per 100,000 males)

Conclusions: The treatment of locally advanced prostate cancer (or T3) is still a controversial topic. Radiotherapy and adjuvant androgen-deprivation therapy are considered standard treatment. The guidelines of the EAU mention that radical prostatectomy is an option for selected patients with small T3a, Gleason score of

Age-adjusted incidence rate increased quickly from 2.9 per 100,000 men in 1987-1989 to 8.2 per 100,000 men in 2002-2007. Conclusions: Prostate cancer was an important public health problem in Algeria between 1987 and 2007. It represents

37


<8, PSA level <20 ng/ml, and a life expectancy of >10 years. Our patients resulted with high levels of PSA; 120, 85, and 60 ng/ml, for the patients with Gleason score 10, and 60 and 45 ng/ml, for the 2 patients with score 9. All these 5 patients were operated 3, respectively 2 years ago. Their course of disease was followed by performing the CT and measuring the PSA levels every 4 months, which showed us that there was no relapse, and their condition was good (being able to do their daily activities and not complaining of pain), so we came to the conclusion that radical prostatectomy can be considered as a favorable choice even for patients with highly advanced prostate cancer, and even when the Gleason score is 10, and should be followed with androgen-deprivation therapy or with subcapsular orchidectomy.

79 Analysis of the seminal vesicles biopsies protocol of the Morales Meseguer Hospital Montoya-Chinchilla R, Rosino-Sanchez A, Miñana-Lopez B, Pietricica B, Cano-Garcia MC, Hidalgo-Agullo G, Reina-Alcaina L, Izquierdo-Morejon E. Urology, Morales Meseguer Hospital, Murcia, Spain Although new MRI techniques have high sensitivity for seminal vesicle invasion, low availability and high cost involved makes it necessary to incorporate cheaper and easier techniques that can assist in the staging of prostate cancer. There are currently no standard indication criteria for seminal vesicle biopsies. Due to the lack of data in this field, an analysis of protocol biopsies of the seminal vesicles of the Morales Meseguer Hospital has been done. The overall rate of seminal vesicle invasion in our study was 15.7%, 25.58% if we only took into account patients diagnosed with prostate cancer. All patients who were biopsied and showed positivity in the three indication criteria for seminal vesicle biopsies proposed, were T3b. Submit any alteration in prostate base, either by physical examination or by ultrasound, has shown a rate of 53.8% of T3b. To our knowledge, seminal vesicles biopsies should be considered as a complementary procedure for staging prostate cancer. It’s comfortable, cheap and with few complications.

78 Moderately hypofractionated radiotherapy treatment using tomotherapy for prostate cancer: toxicity analysis of 64 consecutive patients treated at the Radiotherapy Unit of AOU Policlinico di Modena Bruni A, Mazzeo E, Rubino L, Lanfranchi B, Bertoni F. Radiotherapy, AOU Policlinico di Modena, Modena, Italy Purpose: Curative treatment of patients with prostate cancer (PC) comprises surgery, radiotherapy (RT) and/or hormone therapy (HT). In external beam RT dose escalation is currently investigated to improve outcomes in terms of dose-response relation of local tumor control, biochemical progression free survival and progression free survival. Dose escalation can also be achieved by increasing dose per fraction above 2 Gy and several studies showed that PC cells may be strongly susceptible to this regimen due to their low α/β ratio. However dose escalation and hypofractionation may also increase acute/late toxicities, but the introduction of IMRT may allow us to deliver higher doses without increasing toxicities.

80 Metastatic cervical lymph node in prostate cancer Pascual-Fernandez A, Calleja-Escudero J, Torrecilla García-Ripoll JR, Calvo-Gonzalez R, Martín Martín S, Cortiñas González JR. Urology, University Clinic Hospital, Valladolid, Spain Background: Lymph node metastasis is an uncommon clinical presentation in patients with prostate cancer and it could be suggestive of the diagnosis of malignant lymphoma. Evaluation of the PSA level and lymph node biopsy can lead to the final diagnosis. Furthermore, the Gleason scores should be high in almost all patients. The prognosis after such a presentation was generally poor, with a mean survival of 18 months. Hormone treatment has been shown to be of benefit even in patients in the advanced stages.

Materials & Methods: From February 2008 to December 2011, 64 patients (pts) with PC underwent radical RT using hypofractionation with or without concomitant HT. All of them were treated using tomotherapy. Median age was 71 years. Eight of 64 pts had low risk PC (12.5%), 4 intermediate risk (6.5%) and 52 high risk (81%). About clinical stage, 13 pts had T1 PC (20%), 7 T2 (10%), 10 T3a (15.6%) and 34 pts had T3b (53.1%); pathological pelvic nodes were diagnosed in 5 pts (8%). Thirtyfour pts (53.1%) received neoadjuvant and/or concomitant HT, while 30 pts (46.8%) received even adjuvant HT. Gleason score was less than 7 in 23 pts, equal to 7 in 15 and superior in 16; median Gleason score was 7. RT was delivered to a median dose of 70 Gy in 28 daily fractions (2.5 Gy per day). Clinical target volume included prostate in 2 pts, prostate and seminal vescicles in 34 (53%); pelvic abdominal RT (with prophylactic intent) was performed in 28 pts (43.7%) due to high risk of lymphatic involvement (based on Roach algorithm).

Case presentation: We present the unusual case of a 77-yearsold male with a left neck mass for about 2 months associated to weight loss, fatigue and hyporexia. He denies fever syndrome, night sweats or pruritus. No lower urinary tract symptoms. Cervical CT scan was performed, which showed two adenopathic clusters of 21x23 and 25x27 mm in carotid-jugular area (image 1) extending to left supraclavicular level with a noticeable increase in caliber of the subclavian, axillary and proximal left humeral vein compatible with deep vein thrombosis. In thoraco-abdominal CT scan was objectified left axillary, paraaortic, retrocrurales and throughout the retroperitoneum lymphadenopathy. Serum prostate specific antigen (PSA) was 185.60 ng/ml. Digital rectal examination revealed enlarged prostate with an uneven surface. Cervical node biopsy showed adenocarcinoma that was strongly positive for PSA and AE1-AE3 in immunohistochemical study. Bone scan revealed no evidence of malignancy. Hormone treatment was started with bicalutamide and leuprolide acetate. Six months after initiation of treatment, the serum PSA declined to 1.7 ng/ml. No evidence of significant lymphadenopathy in the control CT scan. Nine months after diagnosis, the patient is still alive.

Results: Median follow up was 20 months; 90% of pts (57/64) are free from disease, 5 pts (8%) had locoregional relapse and 2 (2%) developed metastatic disease. RT was well tolerated with only 4 pts complaining of acute severe urinary toxicity; 1 pt developed a Grade 3 acute rectal side effect. Late Grade 3 rectal toxicity was reported in 4 pts (6%) and Grade 2 urinary toxicity in 3 pts (4%); no Grade 3 urinary late toxicity was found. No treatment related deaths were encountered. Conclusions: No increase of acute and severe side effects was found. Hypofractionated dose escalated RT using tomotherapy seems to be feasible and should be considered in the management of prostate cancer in association with HT.

Conclusions: Prostate carcinoma should always be considered in the differential diagnosis of elderly men with cervical 38


lymphadenopathy, even in the absence of lower urinary tract symptoms.

82

Immunohistochemical stain of PSA can lead to the final diagnosis, but PSA level must be perfomed. Once the diagnosis is established, hormone treatment has been shown to be of benefit even in patients in the advanced stages of the disease.

Sarcomatoid carcinoma of the prostate Calleja-Escudero J, Calvo-Gonzalez R, Valsero-Herguedas E, Pascual-Fernandez A, Bedate-Nuñez M, Pesquera-Ortega L, Cortiñas-González JR. Urology, University Clinic Hospital, Valladolid, Spain Background: Sarcomatoid carcinoma of the prostate is a rare variant of prostate cancer, with few cases reported in the literature up to date. Tumors are most commonly composed of an admixture of both malignant glandular and spindle cell elements. The sarcomatoid component can vary from 5 to 99%. Case presentation: We present a case of solitary sarcomatoid carcinoma of the prostate. It’s a 59-year-old man whose clinical symptoms were dominated by dysuria and frequency. Digital rectal examination showed a very large, hard and irregular prostate. Serum PSA was 181 ng/ml. The patient underwent a prostate needle biopsy and the histopathological examination revealed poorly differentiated adenocarcinoma (Gleason score 5+4=9/10) in all cores of the left lobe and Gleason 7 (4+3) in 1 core of the right lobe. The bone scan showed multiple bone metastases. He was treated with complete androgen blockade and zoledronic. The PSA was 0,21 ng/ml 5 months after. He suffered from acute urinary retention after 3 months, and underwent transurethral resection of the prostate, for the treatment of bladder outlet obstruction. The pathological specimen showed sarcomatoid carcinoma with squamous differentiation. The time between the original diagnosis of acinar adenocarcinoma and diagnosis of sarcomatoid carcinoma was 6 months. The patient died 7 months after diagnosis.

81 Prostate cancer in a Sub-Saharan Africa Gueye SM, Jalloh M, Niang L, Ndoye M. Urology, Univeristy Cheikh Anta Diop and Grand Yoff General Hospital, Dakar, Senegal Background: Prostate cancer has the highest incidence and prevalence of all cancers and in men it is the second non cutaneous cancer after lung cancer. Scant data exist about this cancer in developing countries especially in Sub-Saharan Africa. But obviously there are rising trends on prostate cancer prevalence in Africa. This will increase progressively. Africa is experiencing an epidemiological transition from communicable diseases dominated health care system to non communicable diseases (NCDs) such as cancer, diabetes and cardiovascular diseases. By the year 2020, over 70% of all cancer deaths will occur in low- and middle-income developing countries (WHO).

Conclusions: Sarcomatoid carcinoma is an aggressive variant of prostate cancer, the prognosis of which is dismal regardless of other histological or clinical findings. The pathogenesis of the tumor is still uncertain but most likely represent a radiationinduced dedifferentiation of prostatic adenocarcinoma. Approximately half of all patients develop metastatic disease either at time of presentation or subsequently.

83

The aim of this study was to review published data on prostate cancer in Sub-Saharan Africa.

Conformal radiotherapy for high risk prostate cancer: experience of the Radiotherapy and Oncology departement, Ibn Rochd, Casablanca

Materials & Methods: For this purpose, we searched for publications in the literature in PubMed/Medline, African Journals Online and Conference books of abstracts.

Abdeslam H, Tarik C. Radiotherapy, CHU Ibn Rochd Casablanca, Casablanca, Morocco

Results: Data show a limited knowledge of etiologic factors and screening, generally advanced stage of the disease upon diagnosis. Radical prostatectomy is safely performed for the few localized disease patients; for the rest of the patients, hormonal therapy is the major treatment option.

Introduction: High risk prostate cancer is, according to the classification of D’Amico, defined as locally advanced (T2c and above) or high grade (Gleason 4+3=7 and greater than 7) or is associated with a total PSA value >20 ng/ml. The standard treatment is a combination of conformal radiotherapy and hormone therapy for the long term.

Conclusions: Limited data exist on prostate cancer in Senegal. There are differences in clinical features of prostate cancer in this part of the world. Late presentation is very common. The majority of patients are referred at an advanced stage prompting palliative therapy. Another problem is the lack of adjuvant therapy as hormone therapy, chemotherapy and radiation therapy. Cultural factors are limiting factors to castration. Radical prostatectomy is safely performed for localized disease while radiation therapy is unavailable in most of Sub-Saharan Africa.

Materials & Methods: A retrospective study of 32 patients with high risk prostate cancer who received the combination of radiotherapy and hormone therapy between April 2009 and April 2011. Results: The median age was 66 years (50-84). Stage distribution was as follows: T1c 2, T2a 2, T2b 7, T2c 7, T3a 10, T3b 2 and T4 2 with Gleason score 4-6 in 34%, 7 in 38% and 8-9 in 28% of cases. The PSA value at diagnosis was less than 10 ng/ml in 16% of patients, between 10 and 20 ng/ml in 28% of patients and more than 20 ng/ml in 56% of cases. 18 patients (55%) 39


received hormone therapy including 13 patients who are still on hormone therapy and 5 patients who have received for 3 years. 14 patients underwent surgical castration (46%). All patients received conformal external radiotherapy, delivered by a linear accelerator. The volumes irradiated were the prostate, seminal vesicles and the ilio-obturator lymph nodes. The average dose was 72 Gy (72-76). Only 1 patient received post-operative radiotherapy at a dose of 60 Gy after radical prostatectomy preceded by lymphadenectomy. Evolution in short and long term was satisfactory with an average PSA nadir of 0.255ng/ml (0002-2.2ng/ml). 5 patients had complications (15%): 2 cases of post-radiation cystitis, 1 case of post-radiation rectitis, 1 case of grade I dermatitis and 1 case of urinary incontinence. Conclusions: Our results are promising. External radiotherapy combined with long-term hormone therapy is the standard treatment for high risk prostate cancer. Realized in conformal mode, it decreases urinary and rectal toxicity.

85 Clinical recurrence of prostate cancer with no change in PSA Calleja-Escudero J, Calvo-Gonzalez R, Valsero-Herguedas E, Pascual-Fernandez A, Bedate-NuĂąez M, Pesquera-Ortega L, CortiĂąas-GonzĂĄlez JR. Urology, University Clinic Hospital, Valladolid, Spain

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Background: Prostate cancer often metastasizes to the bones, but it is rare that in patients with castration levels of PSA distant spread takes place.

Peritoneal dissemination of prostate cancer with absence of lymph node, skeletal or visceral metastases in a patient scheduled to undergo robotic-assisted laparoscopic prostatectomy

Case presentation: A 70-years-old patient with a PSA of 44.7 ng/ ml and a hard prostate on digital rectal examination. The biopsy showed a prostate cancer Gleason 4+3 that affected more than 70% of the material. The patient was submitted to a CT and bone scintigraphy which were negative for metastases. The patient was treated with flutamide, goserelin and radiotherapy.

Labanaris AP1, Zugor V 1, Wagner C1, Afram S2, Witt JH1. 1Urology, Prostate Center Northwest, St. Antonius-Hospital, Gronau, Germany; 2Pathology, Prostate Center Northwest, St. Antonius-Hospital, Gronau, Germany Introduction: We report a case of peritoneal dissemination of prostate cancer (PCa) with absence of lymph node, skeletal or visceral metastases in a patient scheduled to undergo roboticassisted laparoscopic prostatectomy (RALP).

After 9 months and a PSA of 0.06 ng/ml, the patient experienced bone pain. The bone scintigraphy showed metastases at D12-L1 and the left rib. The RMN identified a D12-L1 wedge fracture without involvement of the spinal canal. Radiotherapy was applied to D12-L2, and the patient received treatment with morphine and zoledronic acid. The patient experienced persistent pain and was operated by filling the spine with cement; kyphoplasty D12-L1.

Case description: In January 2012, a 62-year-old man was referred to our department with a histological diagnosis of PCa, cT2c cN0 cM0 Gleason 5+4=9. The initial diagnosis was made. His serum prostate-specific antigen (PSA) level was 13.3 ng/ ml. Computerized tomography (CT) of the abdomen and thorax, magnetic resonance imaging (MRI) of the pelvis and bone scintigraphy showed no signs of metastasis. After the robot was docked we noticed an odd macroscopic finding; adherent white patches similar to that of leucoplakia spread on the whole peritoneum, but mostly located under the bladder (Figure).

Six years after continuous treatment with goserelin and zoledronic acid, the patient showed a PSA of 0.6 ng/ml. Conclusions: Although unlikely, castrate PSA levels in any clinical manifestation may indicate spread of the disease.

Decisions & Outcomes: We performed a biopsy, sent it to the pathologist for a frozen section analysis and continued the operation. The diagnosis made was peritoneal cancer due to a small cell undifferentiated cancer. At that time the pathologist was not sure if it was metastasis due to the patients PCa or if it was a metastatic tumor from his gastrointestinal tract. Thus, we decided to perform only a diagnostic lymphadenectomy and end the operation. The final histology exhibited peritoneal cancer due to a PCa Gleason 5+4=9 but tumor-free lymph nodes (0/15). A complete androgen ablation was then initiated with an LH-RH agonist and bicalutamide and in March 2012 the patient had a PSA value < 1 mg/ml. Conclusions: In the future, diagnosis of this rare disease entity will be the result of an extreme advance of the robotic technique in comparison with other operative procedures; an enhanced visibility. According to contemporary literature, treatment should be performed in accordance with the standard strategy for PCa, including hormone therapy and chemotherapy. 40


The status of rectum and bladder make the definite influence on prostate location during radiotherapy. It is important for treatment toxicity and response. In the presented case decreased dopamine level influences rectum volume.

86 Prostate cancer diagnosed at 28 years old – case report Campos L, Rebimbas M, Mota Preto P, Sebastião C. Urology, HDES, Ponta Delgada, Portugal

Case description: A 28-year-old caucasian male presented with a painless dorsal curvature of the erect penis. He was shown to have a PSA level of 3.4 ng/ml in a routine evaluation made by his family practitioner. This PSA value was remeasured and confirmed. Physical exam was normal and digital rectal examination revealed a slightly enlarged prostate. His past medical and family history was unremarkable.

Case presentation: We present a man with clinically T3aN0M0 III prostate cancer which was confirmed by histology. At the time of admittance the patient did not report any urinary symptoms. Medical history included Parkinson’s disease. Pretreatment PSA was 4.7 ng/ml. A transrectal ultrasound-guided prostate needle biopsy revealed prostate adenocarcinoma, with Gleason score 6 (3+3), from 1 lobe 4 positive scores and from the other 2 scores. Whole body-bone scanning was normal. Pelvis MRI confirmed T3a. The treatment was started with a LHRH-agonist, goserelin, and the anti-androgen bicalutamide. The patient was included in a single institution randomized trial comparing sequential standard fractionated 2 stages vs whole pelvis IMRT radiotherapy with hypofractionated simultaneous integrated boost (SIB) IMRT. This patient was randomized to the SIB arm with 3.15 Gy per fraction to be delivered to the prostate and seminal vesicles and 2.2 Gy per fraction to lymph nodes in 20 fractions. On-line CBCT setup before each treatment fraction was mandatory for this trial. During the first fractions large variations in rectum volume and position were observed. Therefore, targets and OARs contours were deformed according to these day-to-day changes. Several treatment plans were created accordingly and applied depending on the day anatomy. The radiotherapy reactions were evaluated with the RTOG questionnaire. After the treatment completion the patient had general weakness. The only toxicity observed up to date was acute GU - I grade, GI - 0 grade.

The penile curvature was corrected using the Nesbit procedure, with satisfactory results. The patient was also submitted to a transrectal ultrasound guided prostate biopsy. Prostate biopsy revealed a Gleason score 6 (3 + 3) adenocarcinoma in 1 of 12 specimens.

Conclusions: The patient which otherwise would be excluded from a randomized trial and most probably even the course of standard RT would be compromised, was successfully treated as planned with this daily adaptive radiotherapy. The toxicity was GU - I grade, GI - 0 grade.

He underwent a radical retropubic prostatectomy and bilateral pelvic lymph node dissection. The final pathology revealed a Gleason score 6 (3 + 3) adenocarcinoma involving approximately 10% of the gland and no lymph nodes demonstrated metastatic adenocarcinoma.

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Three years after surgery, the patient has good oncologic control and reasonable functional outcomes. PSA is under 0.001 ng/ml, complete continence is achieved and erectile function is obtained with inta-cavernosal prostaglandins.

Hainz H, Urology, Maria Hilf Krankenhaus Daun, Daun, Germany

Introduction: Prostate cancer is the fifth most common malignancy worldwide and the second most common in men. Its incidence and mortality rates vary significantly between countries and regions. Evidence suggests that both genetics and environment play a role in the origin and evolution of this disease. However, increasing age is the most well-established risk factor. PSA (prostate specific antigen) was first identified and purified in the late 1970s, but widespread use in clinical urology did not occur for another decade. First used to monitorize treatment, its importance was soon established in prostate cancer screening. The optimal threshold of PSA serum level to recommend a prostate biopsy has come under increasing scrutiny and the standard value of 4 ng/ml is being redefined.

Laser will change surgery of geriatric oncology. Pattern could be history of prostate therapy Worldwide the ageing population needs more medicine; especially minimally invasive surgery that should be affordable everywhere. Prostate surgery started in 1901 when anesthesia enabled painless Freyer. In 1970, TURP with transistors and rodoptics was the first paradigm shift, followed now by laser. Energy increase from the first Rubin laser in1961 enabled step by step LLLT in the prostate; since 1991 coagulation (20W-NdYAG/ Hofstetter) and via cutting in 1998, vaporisation (PVP by 80W KTPLaser/Malek&Kuntzman). With global 300000 PVP until 2007 and 80% of benign prostate enlargment-OP/USA 2010 (mostly outpatient therapy) it is new standard versus TURP.

Conclusions: PSA-based screening has induced an important age migration effect, such that the median age at diagnosis is lower than before, with important implications for deciding on the need for and type of treatment, as well as complications after therapy. To our knowledge, this is the youngest patient diagnosed with prostate cancer.

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Since 1988 we lasered 4000 tumours of the bladder and 2000 prostates. 1996 diodelaser enabled 95% of our surgery; so we came out of “bloody medicine” to meet company to “human treatment”. Most surgeons are not aware of a benefit of the laser; the use of simple glass fibres for coagulation, cutting, vaporisation and atomic photo ablation. The complications of thousands of years old scalpel -<only costs> economically - are reduced impressively. As we lasered transurethral prostate, surgeons can perform minimally invasive or teleguided robot operations with Seldinger punction and modern imaging system in the body.

Adaptive radiotherapy for prostate cancer with rectum problems caused by Parkinson’s disease Karklelyte A, Norkus D, Miller A, Valuckas KP. Radiotherapy, Institute of Oncology Vilnius University, Vilnius, Lithuania Introduction: The utilization of adaptive “plan of the day” radiation therapy in case of complicated prostate cancer treatment is not yet a widely recognized technique. We would like to present a case report on prostate cancer of a 75-year-old man with various rectum-associated problems during the course of treatment, caused by Parkinson’s disease. 41


Future of laser is an old dream of mankind to remove malignant tissue without touching the body. New proton-laser Draco rom FZD www.fzd.de generates and concentrates protons that destroy tumours passing our body without much damage for surrounding healthy tissue â&#x20AC;&#x201C; e.g.CaP.

metastasis in a pelvic lymph node. He had regional volumetricmodulated arc therapy (VMAT) to a target gross tumor volume with a cumulative dose of 78 Gy, and simultaneously VMAT to a field of regional lymph nodes with a cumulative dose of 50 Gy. He had grade 1 acute toxicity after the radiotherapy. During the following 4+ months, PSA declined more than 50%. A repeat [18F] FACBC PET/CT scanning showed a partial remission.

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Conclusions: The effects and side-effects from using PET/CT scanning and regional VMAT for lymph node-positive prostate cancer surpassed expectations of Danish urologists.

Disseminated infiltration of bone marrow due to prostatic adenocarcinoma: presentation of a case Porfyris O1, Kontonis I2, Boutas L1, Tzelepis K 1, Kalomoiris P1. 1Urology, General Hospital of Sparta, Sparta, Greece; 2Haematology, General Hospital of Sparta, Sparta, Greece Introduction: Metastatic prostate cancer is a disease that initially responds well to hormone therapy. Disseminated infiltration of bone marrow due to prostate cancer is an unusual manifestation. Case description: We report a case of prostatic adenocarcinoma with disseminated infiltration of bone marrow, refractory to hormone therapy and with fatal outcome. A 74-years old man was admitted to our department due to urinary retention, haematuria and multiple ecchymoses. Laboratory findings were as follows: Hb=7.9 g/dl, Ht=23.8%, WBC=4900/ml, PLT=35000/ ml, PSA=700 ng/ml. Microscopic examination of peripheral blood showed anaemia, thrombocytopenia and leucoerythroblastosis. Bone scan revealed multiple metastatic lesions. Bone marrow biopsy revealed a hypocellular marrow with disseminated infiltration of a poorly differentiated adenocarcinoma. Prostate biopsy showed an adenocarcinoma of Gleason score 7 (3+4).

91 EXMI therapy before and after radical prostatectomy Jordan M. Urology, Private practice, Munich, Germany I want to inform all urologists about the EXMI technology; its value and advantages, and my experience of more than 13 years with thousands of patients treated before and after radical prostatectomy.

Decisions & Outcomes: The patient was treated with hormone therapy, blood transfusions and erythropoietin. He did not respond well to the therapy and died one and a half month after admission due to brain haematoma.

The EXMI-extracorporeal magnetic innervation is a technology that received FDA approval for incontinence in women in 1998.

Conclusions: Disseminated carcinomatosis to bone marrow due to prostate cancer is rare and has a poor prognosis. It ususally leads to disseminated intravascular coagulopathy. There are no specific guidelines in the literature for the treatment of this condition. Bone marrow infiltration may correlate with a more aggressive subtype of prostate cancer, refractory to hormone therapy.

I learned about it at the first AUA meeting when this amazing technology came on the market. As a specialist in the treatment of incontinence I was so impressed about it that I decided after only 10 seconds that I must own such a system. After I got my first system in my practice I started offering it to my patients and of course my first patient was an incontinent male after radical prostatectomy. He was dry in 8 weeks. In the next 2 months I had so many patients on therapy that I had to acquire a second system. Now the EXMI is available in 56 countries.

90 Volumetric-modulated arc therapy for pelvic lymph node metastasis of prostate cancer shown by anti-1-amino-Ffluorocyclobutane-carboxylic acid PET/CT

The advantages of the EXMI, comparing the electro therapy, bio feedback, kegel exercises, gymnastics and everything you know as a conservative treatment of the pelvic floor are:

von Eyben FE. Internal Medicine, St Olavs University Hospital, Orkanger Hospital, Orkanger, Norway

It is completely non-invasive. Patients stay fully dressed on a chair, 2-3 times/week, for a total of 20 sessions, instead of introducing probes 2 times/day for 6 months, doing unpleasant kegel exercises or gymnastics. Electricity penetrates only 1.2-1.2 cm into the body and the EXMI up to 7.5 cm.

Introduction: Danish urologists claim that radiotherapy for regional lymph node-positive prostate cancer is ineffective and toxic. Case description: A 50-year-old Danish man underwent a radical prostatectomy for prostate cancer (pT3b, pN1, M0, Gleason score 9 (4+5)). Postoperatively, he was given androgen deprivation therapy. Prostate-specific antigen (PSA) declined to unmeasurable levels but later showed a continuous rise to 1.1 ng/ mL 4 years after the prostatectomy. A MR scanning did not show signs of metastases.

It is the only standard conservative therapy of the pelvic floor, not depending on the patient, the physician or any other external factors. The patients get up to 18,000 muscle contractions in a 20-minute session. The compliance is almost 100%. The results depend on the diagnosis and rate between 20-100%. We all know after we made the diagnosis what % of improvement is to be expected, if the patient does the treatment correctly. With the EXMI this % comes true.

Decisions & Outcomes: A [18F] anti-1-amino-3-Ffluorocyclobutane-1-carboxylic acid PET/CT scanning showed a 42


Because it stimulates nerves you can treat effectively also OAB and pain. You can predict with about 10% the outcome if you did the correct diagnosis. It is the best financial help you can get into your business. And for men, radical prostatectomy brings the risks of incontinence and ED with it. EXMI is the instrument every one of us needs in order to prevent and treat these problems effectively. EXMI is life changing both for doctors and for patients.The XXIst century urology without the EXMI is not acceptable any more.

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Authorlist A Abbes M 37 Abdeslam H 39 Abu Eid R 14 Addali M 8 Afram S 40 Ahlering T 19, 28 Ahmad A 11 Ahn HS 27, 31 Aicha DD 37 Akhter W 11 Aksnes AK 1 Alekseev BY 2, 27, 32 Ali E 35 Ali S 11, 35 Aliu H 37 Alvisi MF 26 Ancheta J 11 Anderson C 5, 36 Andrianov AN 2, 27, 32 Andriole GL 10 Armstrong AJ 1 Audia S 3 Autier P 16 Avuzzi B 26, 33

B Baco E 21, 30 Bailen J 11 Barbazza R 16 Bardelli I 28 Barua J 11 Bary P 4 Bassi PF 35 Bedate-Nuñez M 27, 30, 39, 40 Bedini N 14, 26, 33 Belej K 32 Bellardita L 21, 33 Benslimane L 10 Berge V 21 Berthold D 30 Bertoni F 38 Bezhani E 33 Biasoni D 26, 33 Bidair M 9, 11 Biggin C 1 Bonin S 16 Bordier B 15 Borghesi M 28 Bourgois N 3 Boutas L 42 Braeckman J 16 Brandenburg JJI 14 Brausi M 17 Brett A 5

Brown E 9 Bruland ØS 1 Bruni A 38 Burette R 3 Busby E 9

Devcich G 4 De Visschere PJ 9, 20 D’Hondt F 9 Di Cristofano C 29 Djamel A 37 Donegani S 33 Duasko S 31

C Cagna E 18 Cahill D 26, 31, 34 Calais da Silva FE 17 Calarco AC 35 Calleja-Escudero J 27, 30, 38, 39, 40 Calvo-Gonzalez R 27, 30, 38, 39, 40 Campos L 41 Cano-Garcia MC 38 Carbone A 29 Carneiro R 36 Carpentier P 28 Catania S 21, 26 Challacombe B 26, 31 Chandra A 31 Chang A 19 Chang RTM 26, 31, 34 Chapelon JY 21 Cheng L 35 Chi KN 1 Chinegwundoh F 11 Chmelik F 32 Cho DS 27, 31 Choi JB 31 Colecchia M 26 Collette ERP 5, 7 Collette L 30 Corbishley C 5 Corbusier A 3 Cortiñas González JR 38 Cortiñas-González JR 27, 30, 39, 40 Crouzet S 21 Cuni H 33 Cuni Xh 33 Cussenot O 13, 15 Cuzick J 11

D

E Edenbrandt L 7 Efros M 11 Eggesbø HB 30 Egner T 29 Engel RP 5, 7, 26

F Faik M 10 Fellin G 18 Feng Z 9 Ferber A 29 Ficarra V 28 Fiorino C 18 Fizazi K 1 Fonteyne V 6, 9 Fossion LMCL 8, 14 Franco N 11 Fukami N 20 Fukaya K 20

G Gabriele P 18 Gattenloehner S 14 Gelet A 21 Germeau F 3 Gittelman M 11 Gjertsson P 7 Gonçalves F 17 Green J 11 Grivas N 15 Groskopf J 9, 11 Gross-Langenhoff M 32 Gueye SM 39 Gujral SJ 13

H

Damber J-E 34 Damber JE 7 Dass RN 12 de Bono JS 1 de Braud F 14 Decaestecker K 6 De Coninck V 16 De Groote R 9 de Lange DCD 26 De Meerleer G 6, 9 De Naeyer G 28 De Potter A 20 Desai S 16 De Troyer B 6

Habibzada J 5 Hainz H 41 Hamal M 3 Hamann C 12 Hamann MF 12 Hamberg P 12 Han KS 30 Hastazeris K 15 Hawaux E 4 Hawizy A 13 Haxhiu A 33, 37 Haxhiu E 37

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O

Haxhiu I 33, 37 Heinrich E 29 Henderson RJ 11 Hertzman B 11 Hidalgo-Agullo G 38 Hines J 11 Hirmand M 1 Höglund P 7 Ho L 11 Holmes MA 4 Holz S 4 Hong SJ 30 Hong SY 27 Hoshinaga K 20 Hyseni S 37

Laghi A 29 Lanfranchi B 38 Laungani RG 20 Lee A 11 Lencastre J 36 Leyland J 4 Limani K 4 Lin D 9 Liss M 28 Lomsky M 7 Lopes F 12 Lotan Y 9 Luedecke G 14 Lumen N 6, 9, 36 Lusch A 28

I

M

Iken A 10 Ishise H 20 Issa R 5, 36 Izquierdo-Morejon E 38

Maes H 6 Magnani T 21, 26, 33 Malavaud B 13, 15 Marchesin F 16 Marenghi C 21, 26, 33 Martini M 35 Martín Martín S 38 Maruyama T 20 Mauro FA 18 Mazzeo E 38 McMeekin F 11 Meesen B 15 Meiers I 31 Michielsen D 16 Miller A 41 Miller K 1 Miñana-Lopez B 38 Mokhtar HC 37 Monteiro H 12 Montoya-Chinchilla R 38 Morales B 19 Morris E 31 Mota Preto P 41 Mota R 12 Mottet N 13, 15 Mottrie A 6, 28 Mulders PFA 1 Musch M 2

J Jalloh M 39 Jelski J 11 Jordan M 42 Juenemann KP 12

K Kaboteh R 7 Kafarakis V 15 Kagan J 9 Kalomoiris P 42 Kaplan O 32 Karklelyte A 41 Kelkar A 13 Khalil F 10 Khan Y 5 Kibel AS 9 Kim S 27, 31 Kim SJ 27, 31 Kim YS 31 Kinsella J 26, 34 Klaver OS 5, 7, 26 Klevecka V 2 Kliffen M 5, 7, 26 Kliment J 17 Klonowski W 14 Kocarek J 32 Kohler O 32 Kontonis I 42 Koziol I 11 Kröpfl D 2 Kusaka M 20

L

Ohlmann CH 32 Ohlsson M 7 Oliver T 11 Oosterlinck W 9 Osann K 19, 28 Osimani M 29 Ost P 6, 9

P

N Nargund V 33, 35 Naumann CM 12 Ndoye M 39 Neves T 12 Niang L 39 Nicolai N 26, 33 Nilsson S 1 Norkus D 41 Nyushko KM 2, 27, 32

Labanaris AP 3, 5, 6, 8, 40

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Palleschi G 29 Paolini B 26 Parker C 1, 13 Partin A 9 Pascual-Fernandez A 27, 30, 38, 39, 40 Pastore AL 29 Pati J 33, 35 Patil A 16 Peltier A 4 Perry M 5, 36 Persson B-E 34 Pesquera-Ortega L 27, 30, 39, 40 Petrozza V 29 Pierconti F 35 Pierris N 19 Pierzchalski M 14 Pietricica B 38 Pinney L 11 Pinto F 35 Plümmer J 2 Popert R 26, 31, 34 Porfyris O 42 Pracella D 16 Praet M 9 Procopio G 14, 33

Q Queimadelos M 17 Quni Xh 37

R Raina S 16 Rambaran SS 5, 7, 26 Ramos R 12, 36 Rancati T 18, 21, 26, 33 Rebimbas M 41 Rebola J 36 Recupero SM 35 Reina-Alcaina L 38 Rengo M 29 Robertson C 17 Rodrigues T 12 Roggenbuck U 2 Roggero E 16 Rosino-Sanchez A 38 Rottey S 9, 36


Rouviere O 21 Rozet F 13, 15 Rubino L 38 Rud E 21, 30 Ruffion A 13, 15

Tsimaris I 15 Tsui M 31 Tunn UW 32 Turner B 11, 33, 35 Tzelepis K 42

S

V

Saad F 1 Salvioni R 14, 21, 26, 33 Sanda MG 9 Sasaki H 20 Schatteman P 28 Scher HI 1 Schiefelbein F 29 Schoen G 29 SebastiĂŁo C 41 Segaran S 11 Selby S 1 Shin TY 31 Shiroki R 20 Siegel FP 29 Silva E 36 Silva J 36 Skarecky D 19, 28 Skolarikos A 19 Slimane L 37 Smets L 10, 13 Smit-Archer L 4 Sokoll L 9 Speakman M 11 Spencer M 12 Srivastava S 9 Stagni S 14, 33 Stamatiou K 19 Stanta G 16 Staudacher K 1 Stavropoulos NE 15 Stepien P 14 Stepien RA 14 Sternberg CN 1 Stoevelaar H 10, 13, 15 Suardi N 28 Svindland A 30

Valdagni R 14, 26, 33 Valsero-Herguedas E 27, 30, 39, 40 Valuckas KP 41 van den Ouden D 26 van Dooren VPM 8 Van Leer P 3 Van Poppel H 34 Van Praet C 6, 9, 36 van Velthoven R 4 Vavassori V 18 Verbaeys A 9 Verzoni E 14, 33 Villa S 14, 26, 33 Villeirs G 6, 9, 20 Viterbo R 9 von Eyben FE 42 Vorobyev NV 2, 27, 32 Vyas L 26, 31, 34

T Tanabalan C 33, 35 Tanase M 14 Taneja S 9 Taplin ME 1 Tarik C 39 Tartari F 33 Taylor D 30 Terry B 11 Thompson I 9 Tombal B 10 Torrecilla GarcĂ­a-Ripoll JR 38 Totaro A 35 Trojan L 29

W Wagenlehner F 14 Wagner C 3, 5, 6, 8, 40 Waliszewski P 14 Ward J 11 Warren MA 36 Weidner W 14 Wei JT 9 Wells P 33, 35 Wheatley Price P 12 Williams T 11 Witt JH 3, 5, 6, 8, 40

X Xhani M 33

Y Yamamoto H 31 Yoon IS 31 Yusuf T 33

Z Zaffaroni N 33 Zoubida Z 37 Zou J 1 Zugor V 3, 5, 6, 8, 40

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28-30 june 2012

3 days of focus on clinical decision making From diagnosis to managing advanced disease

Global Congress on prostate cancer Multiple mirrors for better management THE EGG Brussels Belgium

Oral presentation in the poster area: moderated poster sessions During the lunch breaks on Thursday and Friday moderated poster sessions will take place in auditorium 3 and in meeting room 4 at the Riverside wing. For detailed programme see live screens or http://live.prosca.org

Upcoming Mirrors of Medicine publications Mirrors of medicine Congress proceedings

Summary of science for practice

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Abstractbook Prosca 2012