ANZUP's A little below the belt, issue 10, December 2018

Page 1

A little below the belt Conducting clinical trial research to improve outcomes for bladder, kidney, testicular and prostate cancers











What is ANZUP? The Australian and New Zealand Urogenital and Prostate Cancer Trials Group was formed in 2008, bringing together a world-leading multidisciplinary team of doctors, nurses, other health care professionals, scientists, researchers, and community representatives, all working in areas related to urogenital cancer. Urogenital cancers are those coming from the testicles, prostate, kidney or bladder. ANZUP’s work aims to improve the ways a patient with these cancers is treated. Our members and investigators are widely dispersed and busy, working in a range of disciplines. To bring a trial to fruition, it is much more productive to get people together to work through the science, develop trial concepts, write the protocol documentation, and other things that need to be done. All of this is separate from the other task of sourcing other resources including funding to support much larger amounts of money to support the trials themselves.

We thank and acknowledge AstraZeneca for their invaluable support in ensuring the dissemination of ANZUP’s consumer magazine, ‘A little below the belt’.

The paper used in this edition is called Maine Recycled Digital – Silk. It is made with fibre derived only from sustainable sources and produced with a low reliance on energy from fossil fuels. The purchase of carbon offsets compensates for emissions produced over an international supply chain, from seedling through to final delivery to the customer. A LITTLE BELOW THE BELT 3

The 2018 Below the Belt Pedalthon, Sydney More information on page 55

What’s inside 05 Message from the Chair, Professor Ian Davis 07 Vale Jonathan Cantwell 08 10 Years of ANZUP 11 Consumer Advisory Panel update

ANZUP Cancer Trials Group Limited Registered office Level 6 Lifehouse Building 119-143 Missenden Road Camperdown NSW 2050 T: +61 2 9562 5042 F: +61 2 9562 5008

@ANZUPtrials / @BTBPedalthon

ANZUPtrials / Below the Belt Pedalthon

ANZUP below.the.belt

ANZUP Cancer Trials Group

14 Vale Alastair McKendrick 16 Spotlight on prostate cancer 17 Treatment choices and decision making with Dr Gavin Marx and Rob Palmer 20 Powerful partnership continues the fight against prostate cancer 20 ANZUP welcomes PCFNZ 21 The role of ICECaP in demonstrating economic value 22 Spotlight on testicular cancer

23 TIGER Trial 24 Spotlight on kidney cancer 25 The evolution of kidney cancer treatment 26 Spotlight on bladder cancer 27 Mike’s Surf Coast Century assault – the comeback story 30 What is on the horizon for bladder cancer? 31 Patient experience of participating in an ANZUP clinical trial 32 Practical advice for dealing with cancer with expert opinions and survivor insights 34 Clinical trials awareness campaign 35 Celebrating five years, changing the face of cancer

ACN 133 634 956

35 Australian medical research delivers outstanding returns on investment

ABN 32 133 634 956

37 Current ANZUP Trials 48 Trials in follow up 50 Fundraising champions

Published by ANZUP Cancer Trials Group Ltd. Copyright. Editor Lucy Byers. Contributing editor: Gillian Bailey. Graphic design by Designcycle


51 ANZUP Pedalthon 66 Thanks to Corporate Supporters and In-Kind Supporters

Message from the Chair, Professor Ian Davis Welcome to this latest edition of “A little below the belt.” We are required at this point to include some warnings, for your safety. This publication: • May contain traces of nuts. • Talks about rude / dangly / inconvenient bits. • Might be a bit confronting if you haven’t thought about it before. • Might be a bit confronting if you’ve had personal experience of all this, either directly or indirectly. • Might inspire you to contribute to a great community of people dedicated to make a difference. If this is your first contact with ANZUP and what we do, your life will forever after be able to be divided into “before ANZUP” and “after ANZUP.” You’re welcome! Now that you’re thoroughly confused, what are we on about? ANZUP Cancer Trials Group is here to make a positive difference to improve outcomes for everyone affected by “genitourinary cancers,” which are cancers of the prostate, kidney, bladder, and testicles. Collectively these cancers make up the majority of cancers in our community and are responsible for causing a lot of damage to all of us collectively, in the form of illness, decreased ability to live the lives we want and need to live, survival, and financial and other costs to the community. Many of these cancers can be effectively treated and even cured, especially if they are found early enough. Unfortunately, for some of these cancers, when they have spread they might not be able to be cured, although we do have treatments that can help control them and improve outcomes for people. Positive difference. Improved outcomes. That’s good. That’s worthy of support. We’re all in favour. But at the moment what we have is sometimes just not good

enough. Too many people continue to suffer the effects of these cancers. For some people, the effects of the cancer or its treatment can continue to cause distress even if the cancer has been successfully treated and cured. We need better, more effective, easier, better tolerated, cheaper, more accessible treatments. We also need to improve our understanding of everything about these diseases: how and why they start; why some cause more problems than others; why some respond to treatment and others don’t; what the other effects are that the cancers and the treatments cause for people; how to support people better through all of this; and what this means for our society as we try to understand how better to use scarce healthcare resources. ANZUP is a diverse group of over 1400 health professionals, scientists, researchers, and community representatives, all involved in the care of people with genitourinary cancers or in research about these conditions. We came together because we recognised there was a major gap. Basic research into these cancers continues to grow very productively and we understand them much better now than we did a few years ago. However, none of that research translates into benefit unless somehow we can adapt it to inform how we should treat or support people better. What’s the missing link between all this great basic research and the goal we want to get to, of improved outcomes? The only way to get there is to take this information into clinical trials, and that is the reason for ANZUP’s existence. We are clinicians: we look after people affected by these cancers. We are scientists and researchers: we are doing the work that will lead to new treatments or better support, and we are linked to the wider community around the world doing similar things, so we can. We are members of the community: all of us have been touched in some way by these cancers, some more directly than others, and we have


direct community input into everything that we do. This all means that we see where the gaps in evidence are and where the opportunities to improve might be, that we can “scan the horizon” for new opportunities, that we can listen effectively to what the community wants and needs from us, and hopefully through newsletters like this one and by other means we can communicate effectively back to the broader community as well. It’s important to do that part, so that people understand the importance of these cancers and of clinical trials, and are able to influence and support what we do. Clinical trials are the main thing that we do. This is how we generate the evidence that allows your health professional to give you advice, and helps you to make decisions about your treatment. It’s easy as a concept but to do it well means doing it meticulously. That in turn takes considerable time and other resources including money. But it’s too important to stuff up. The benefits of doing it well are enormous, and the price of doing it badly is unthinkable, so it has to be done properly.

“Clinical trials are the main thing that we do. This is how we generate the evidence that allows your health professional to give you advice, and helps you to make decisions about your treatment.”

You will read in these pages some reports from our various committees, which are the “engine rooms” of ANZUP where the ideas arise and are nurtured. You will read about our extensive clinical trial activities, amounting to thousands of patients treated on ANZUP trials in Australia, New Zealand, and around the world. You will hear about our many other activities, including basic research, our annual scientific meeting, educational events for our members, information provision for the wider community, events to raise awareness and for fundraising, mentorship and support, of emerging clinicianresearchers, and some new initiatives that have arisen through very productive relationships with various stakeholders. And we’re only ten years old. It is difficult to believe, but we have only been in existence since 2008. During that time people have recognised the importance of what we do and have joined us to contribute their knowledge, expertise and time. ANZUP now leads multinational clinical trials of hundreds or thousands of patients, which the world watches with great interest. Some of our trials include highly novel approaches never tested properly before. Other trials might use older or more established treatments, testing variations to see if we can improve further on what we already do. Not all trials are the conventional treatment ones: some of our most important work is about listening to people, providing better support, and helping people through the challenges of life after a cancer diagnosis.


Are you interested in helping? You already are. As you read this publication you are raising your own awareness of the importance of these cancers and the importance of clinical research. You might mention it to someone else: suddenly you’ve become an ambassador and supporter of our cause. You might be moved to donate to ANZUP or take part in its fundraising activities. That in itself raises awareness, and obviously the funds that are raised are enormously helpful to us as we do our work and continue to expand our activities.

Fun facts about ANZUP: • We get some funding from the Australian Government, which provides some useful support but comes nowhere near covering our basic costs. • Those government infrastructure support funds cannot be used to run clinical trials. Every clinical trial we do needs to have its own funding. • Clinical trials are expensive, often costing millions of dollars. Every little bit helps. • ANZUP is registered as a charity in all states and territories of Australia and in New Zealand. Donations to ANZUP are tax-deductible. • Some of our fundraising goes to support researchers who do not have other means to support their research. • Some of our fundraising, especially through the Below the Belt Research Fund, goes to support ideas that are not yet fully fledged clinical trials but might evolve into them. This is one way we continue to grow ideas for future work. • Every dollar raised through the Below the Belt Pedalthons for the Below the Belt Research Fund goes back to support research. ANZUP does not even take the cost of running those events out of the funds raised through them. We cover those costs by initiatives other than fundraising events. Do you know of many other charities with 100% investment of fundraising back into their cause? • You can join us as a Friend of ANZUP and be kept up to date with all of our activities. People affected by these cancers need better treatments and better support. ANZUP is doing the absolutely critical work of addressing those needs. You will read in these pages about some of our recent accomplishments, and other points of celebration over our so-far short existence of ten years. We’ve come a long way but there is still much to be done. You’re already helping by spreading the word, and perhaps there might be other ways you can help as well. Thanks for your interest in ANZUP. IAN DAVIS Chair


Vale Jonathan Cantwell ANZUP was saddened to hear the news of the death of Jonathan Cantwell, our extraordinary Melbourne Pedalthon ambassador.

We thank Jonathan for raising awareness of the importance of clinical trials and for his amazing energy and enthusiasm in supporting our inaugural Melbourne ride.

Jonathan was a highly successful Australian professional road bicycle racer, father of two and CEO of custom bikes manufacturer Swift Carbon Australia. In 2017 he announced he had beaten testicular cancer, something he had been fighting privately.

Jonathan will be greatly missed by all of us at ANZUP.

ANZUP was delighted to have Jonathan as the 2018 Below the Belt Pedalthon Melbourne ambassador. Jonathan said the event and cause were close to his heart ‘It’s just awesome to be part of the Pedalthon, with these amazing people riding at Sandown to defeat below the belt cancers’.


Like cycling, don’t like cancer? Help us defeat below the belt cancers by riding or supporting the Below the Belt Pedalthon


Sunday 17 March 2019 Sandown Racecourse, Springvale, Victoria

Venue Partner:

Every cent we raise through the Pedalthon goes directly towards clinical trial research for testicular, prostate, kidney and bladder A LITTLE BELOW THE BELTcancer. 7

10 Years of ANZUP by Margaret McJannett, ANZUP CEO

Over the past 10 years ANZUP has grown remarkably and come a very long way. During this decade ANZUP’s number one priority has been to conduct high quality clinical trial research to improve treatments and outcomes for patients and their families who are affected by below the belt – prostate, bladder, kidney and testicular – cancers. The hard work and time given by so many has brought us to our 10th anniversary and allows us to continue to support the needs of our membership, the community, clinical trials research and most importantly, the patient. As we reflect on this time, we celebrate what we have achieved.

2008 to 2018: a decade of progress In 2008 the Australian Prostate and Urogenital Cancer Group (APUG) and Australia & New Zealand Germ Cell Trials Group (ANZGCTG) merged and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) came to be. Since 2008, we have grown from 150 members to more than 1460 members across more than 20 disciplines in 2018.

1460 members



SINCE 2008



Registered Nurse

172 Clinical Trials Coordinator


169 Trainee Urologist

161 Medical Oncologist


Medical Oncologist Clinical Trials Coordinator Registered Nurse Trainee Urologist Radiation Oncologist Allied health Scientist Psychologist Nuclear medicine Supportive care Fellow Student

Radiation Oncologist


236 194 172 169 161 107 61 61 27 22 20 15 15

Pathologist Consumer advocacy Pharmacist Epidemiologist Statistician Radiologist Endocrinologist Health economics Medical physics Anaesthetist Surgeon General Practitioner

13 13 10 9 8 5 4 3 2 2 3 1

ANZUP is now recognised nationally and internationally for clinical trials in below the belt cancers. In each of the cancers we represent we now have active clinical trials and also work closely with those undertaking supportive care research, translational research, health economics as well as many other areas of importance. Over the past decade we have set up collaborations with trials groups in in Australia, New Zealand, Ireland, UK, Europe, USA, Canada, with others planned. Collectively these trials involve thousands of patients. We continue to collaborate at major national and international meetings sharing and promoting the work we undertake. In February ANZUP hosted Australia’s first Asia Pacific (APAC) Advanced Prostate Cancer Consensus Conference (APCCC) Satellite Symposium. This symposium brought together 20 experts from 15 APAC countries to discuss the real-world application of consensus statements from the 2nd Advanced Prostate Cancer Consensus Conference held in St Gallen in 2017. It highlighted the advantages and challenges in caring for advanced prostate

cancer patients in the APAC region. The meeting also highlighted the critical importance of a multidisciplinary team-based approach to treatment and delivery of bestpractice care. As we look to the next 10 years and beyond, we must mentor and include young researchers and clinicians of the future. Therefore, we continue to offer educational events and mentoring to encourage the subsequent generation to share ideas and concepts that should hopefully lead to more clinical trials and ultimately improve outcomes in prostate, bladder, kidney and testicular cancers.

Fundraising remains a major part of our activities as clinical trials are extremely expensive undertakings. Over the past 10 years we have established and held five Sydney Below the Belt Pedalthon’s and our first Melbourne Pedalthon. These events are truly inspiring and we continue to be humbled by the commitment of riders, donors, supporters and volunteers – all of whom contribute to the many laps cycled and all the funds raised.

IN 2018



ANZUP continues to bring together a large cross-section of disciplines to our ANZUP Annual Scientific Meeting, the ANZUP Genitourinary (GU) Preceptorship, the Best of GU Oncology Evening Symposium and four concept development workshops. Each educational event provides a platform to present and discuss the latest updates in cancer diagnosis, treatment, research and supportive care. In addition, our concept development workshops mentor those early in their career and have grown to full day workshops. The concepts presented may one day lead to full clinical trials.

















4,414 LAPS



4,176 LAPS



5,400 LAPS










In 5 years the Below the Belt Pedalthon has raised over $1.4 million, welcomed 1,500 riders and awarded funding to 18 research projects. Pretty amazing outcome with all of this funding directed to the Below the Belt Research Fund supporting our members in developing their research ideas that could potentially lead to future ANZUP trials. ANZUP will continue to strive to support its own trials and the Pedalthon provides a step in that direction.









Members of the community, including patients, survivors and their family have attended our annual free Community Engagement Forum over the last six years. This forum allows us to provide information to the public regarding ANZUP and ANZUP-led trials, why clinical trials are important and how we are trying to improve treatments and outcomes for our patients. We have also partnered with Breast Cancer Trials to deliver a clinical trials awareness campaign via the Tonic Health Media network to provide key messages to the general public through GP clinics as well as empower patients and their families to ask, “Is there a clinical trial suitable for me?” These education initiatives are vital for us to raise awareness and provide the general public with information to make informed decisions, and understand the importance of clinical trials and the work we do as we continue to strive to improve outcomes for our community. We are extremely proud of our community magazine, ‘A little below the belt’. We now distribute the magazine to our members, 500 cancer centres, stakeholders, Friends of ANZUP, supporters and donors. Please take the time to read about all of our activities and the people involved and let us know if you would be interested in receiving additional copies.


Finally, a big thank you to all the individuals and organisations who fundraise or support us in other ways. Without their energy, endorsement and funds we would not have been able to, and continue to, strive towards making a difference. As we need to find funding for every project we undertake we fully appreciate all contributions received. We would also like to thank all corporate supporters, many of whom have worked with us over the past 10 years. In addition, we would like to thank our in-kind supporters. By providing their services or products pro-bono their generosity has let us better engage with those affected by kidney, bladder, testicular and prostate cancer, and to spread the word about the importance of clinical trial research. The ongoing commitment of our community, ANZUP members and their patients has allowed us to reach our 10th anniversary. We have made a difference but there is still more to be done. With your continued support we will make a difference to the lives of people affected by bladder, kidney, testicular and prostate cancers. Wishing you and your families the very best for the festive season and a Happy New Year. MARGARET MCJANNETT CEO, ANZUP Cancer Trials Group

Consumer Advisory Panel update By Belinda Jago, CAP Chair

The ANZUP Consumer Advisory Panel otherwise known as the CAP consists of a group of people from the general community who have been touched in some way by cancer. They may be a patient, a cancer survivor, the partner of someone who has had cancer or have been a carer to a family member or friend. At some point CAP members will have expressed an interest in taking on a voluntary role and use their experience in a positive manner to ensure that the development of each clinical trial will have considered the patient’s perspective to use their experience in a positive manner to ensure that the development of each clinical trial will in fact be of benefit to cancer patients in some way. ANZUP has one of the largest CAP’s as we have representation of the four genitourinary cancers we focus on, commonly referred to as “below the belt” (bladder, kidney, testicular and prostate) cancers. A CAP member’s key focus is their commitment to clinical trials for improving the outcomes of those affected by cancer. This includes supporting and promoting every person’s right to information concerning trials and their right to make a personal and informed choice. As consumer advisers we are not expected to have specific expertise about the scientific or medical merits of a trial but we are asked to provide the perspective of someone who has been through a similar or related experience. CAP members participate in regular disease specific sub committees (where ideas for clinical trials are discussed) and we are able to offer comments, ideas and suggestions for improvement at every level where an idea is being considered for development. The CAP is a voice on behalf of the community that it represents and will review proposed clinical trials and the following are some typical questions that we consider: • W ill the clinical trial treatment being proposed be of more benefit to the patient than the current standard treatment? • W ill it offer less side effects?

• Is the trial criteria so narrow that it will be difficult for the patient population to be included? • W ill the treatment schedule be hard to manage in terms of time and travel for patients compared to standard options? • Is the treatment taken at home or in an outpatient/ inpatient setting? One of the really important areas that the CAP reviews is the Patient Information and Consent Forms (PICF). All patients receive a PICF when they are considering whether a clinical trial may be their best option. The CAP reviews these PICF to make sure that the information that will be provided to the patient is well written in plain, non-technical language with a minimum of acronyms and with consideration for patients where English maybe a second language. The CAP looks at the actual treatment information being given to patient to make sure that it is clear and covers what the patient will need to know to make an informed decision as to whether the trial is suitable for them. The ANZUP CAP have had the opportunity to offer some really good ideas into the review process of these PICF with our suggestions being taken on board by the lead investigators and some of the suggested changes being implemented. The ANZUP CAP is committed to working as advocates on behalf of the community that it represents to ensure that well balanced and meaningful clinical trials are developed to continue to improve patient outcomes in the future. I hope this overview gives you a greater understanding of how complex and how much work goes into bringing a clinical trial to the stage that it starts recruiting patients and that it is not just about the science – it is about you the patient . The ANZUP Annual Scientific Meeting (ASM) was held in July. The ASM provides the CAP with an opportunity to take part in education sessions and the chance to meet with clinicians and researchers, providing input from a consumer perspective into ANZUP clinical trial research.

• Will it make a procedure more comfortable? • W ill a new surgical option be as effective when it is less invasive reducing hospital and recovery time?

“ is not just about the science - it is about you the patient.” A LITTLE BELOW THE BELT 11

The 2018 World Cancer Congress By Leonie Young, CAP member


The CAP meets face to face at the ASM, where we are provided with a comprehensive education program to support the works we do as CAP members. At the ASM, the CAP launched a short clinical trials awareness and engagement video. Apart from launching the screen career of CAP member Les Land, the video was received very well by the membership. It was screened in 1,900 GP waiting rooms across the country in July and will be relaunched over December and January – you can read more about the campaign on page 35. The CAP played a strong participatory role in several of the sessions at the ASM. CAP member Colin O’Brien was also invited to present at the ASM in the session, ‘At what cost? Do the latest therapies put people first?’ His personal experience on the ‘cost of dignity,’ as part of his prostate cancer diagnosis and treatment sent a powerful message about the importance of putting people first. In late September we lost one of our valued and committed CAP members Alastair McKendrick. He was a great supporter of ANZUP and committed to clinical trial research. We will miss him and continue to work as hard as we can to contribute to improving outcomes. COLIN O’BRIEN AT THE ASM

The 2018 World Cancer Congress was hosted by the National Cancer Society of Malaysia from 1 to 4 October in Kuala Lumpur. This congress is an initiative of the Union for International Cancer Control (UICC) and hosts approximately 2,500 delegates from 100 countries. I was delighted to be joined by friend and the Immediate Past President of the UICC, Australia’s Professor Sanchia Aranda, CEO of Cancer Council Australia. This year’s theme was “Strengthen, Inspire, Deliver” and it certainly managed to do just that. I spent most of my time in the Patient Group Pavilion, a forum specifically for patients and consumer advocates, which was a very vibrant and inspiring place to be. It offered a vast diversity in topics presented ranging from patient stories to health professionals and cancer organisations sharing their knowledge and successes concerning people affected by cancer. I submitted two abstracts which were subsequently accepted for presentation and I was invited to Chair the Navigating Cancer Care session. The topics I presented were Consumers Having an IMPACT on Cancer Research and Mere Survival or Meaningful Survivorship. The presentation about consumers and research was a play on words referring to my experience with Breast Cancer Trials’ (BCT) Consumer Advisory Panel and its IMPACT Program. I used this opportunity to talk about ANZUP’s Consumer Advisory Panel and the work we do in collaborating with ANZUP researchers as well as the work and legacy of BCT’s Consumer Advisory Panel. In the time allocated I tried to highlight our important role and how these collaborations impact on research outcomes. It was very well received and people were interested to hear about ANZUP’s research agenda. My presentation relating to survivorship focused on strategies to manage once the words ‘You have cancer’ are uttered. This is one of my pet topics because it can impact people’s lives so dramatically if not managed well.

As 2018 draws to a close, on behalf of the ANZUP CAP, I wish all our readers a festive and safe Christmas.


It was a rewarding experience and a fantastic opportunity to network and learn what others do and how they manage many of the similar issues we all face in our advocacy efforts.

Community Engagement Forum


ANZUP held the sixth annual Community Engagement Forum in Sydney on Sunday 8 July. The free event provided an opportunity for patients, their families / carers and the community to engage with an experienced team of healthcare professionals and patient advocates, along with presentations and panel discussions covering a variety of topics.

‘a broad spectrum of subjects – it was brilliant.’ Forum attendee

The forum opened with ANZUP chair Professor Ian Davis providing a brief overview of ANZUP, and how ideas move from the concept stage to clinical trials. The next topic was presented by Professor Suzanne Chambers, AO, who stressed the importance of quality of life when

undergoing cancer treatment. A highlight of the forum was Associate Professor Gavin Marx and his patient, Rob Palmer, who provided the audience with an informative account of their shared decision making process in Rob’s treatment on a ANZUP clinical trial. Associate Professor Richard De Abreu Lourenco discussed the impact of the cost of cancer care, Dr Haryana Dhillon provided guidance on making emotional, social and lifestyle changes after cancer, and nurse practitioner Kath Schubach addressed the effect that cancer can have on sexuality and intimacy. To conclude the forum an engaging panel discussion with audience participation was facilitated by Leonie Young, with a lot of questions to be answered.



‘Relevant, focused and well presented’ Forum attendee

‘No technical jargon, very conversational and engaging’ Forum attendee


Vale Alastair McKendrick by Margaret McJannett, ANZUP CEO

On Tuesday 25th September 2018, some 14 years after his initial diagnosis with renal cancer, Alastair McKendrick, a treasured member of ANZUP’s Consumer Advisory Panel (CAP) died. Alastair was married to Alison for over 40 years, sharing a life of changes, adventure, and joy. Together they had two sons, and were delighted to see one of them married earlier this year. Alastair had a very successful professional career starting out in the UK and becoming Group Finance Director of SMEC (Snowy Mountains Engineering Corporation) before his retirement. Alastair joined the CAP back in 2015 and was a strong advocate and contributor to ANZUP across all our research activities. Despite living through his own cancer challenges, he channelled his energy into ANZUP to promote the importance of clinical trials research. Alastair continued to fly the flag at the inaugural Melbourne Below the Belt Pedalthon in March 2018, attended the renal cancer committee teleconferences and several concept development workshops, and was active at our recent 10th anniversary ASM in July.

When asked why he joined ANZUP’s CAP he responded, “I have been involved in ANZUP for several years now and am amazed at the strides that have been made. Whilst there have yet to be any trials that would be suitable for me, I believe that the work being done by ANZUP across the spectrum of cancers is inspiring and I aim to make whatever contribution I can to helping the organisation achieve its goals”. We thank and acknowledge Alastair for his unwavering contribution to ANZUP. We are particularly grateful for his invaluable insights from a patient perspective, and his dry sense of humour that he never lost even at the most difficult times. His dedication and commitment will continue to inspire us and help us to focus on our mission. From all of us at ANZUP, our deepest sympathy to Alison and his family. His parting words to us now take on greater significance: ‘Tell them to work harder!’ And that we will do in his memory. We are privileged to have known Alastair and to have had him as part of our ANZUP community.








Have you or your loved ones been affected by below the belt – prostate, kidney, bladder and testicular - cancers? Do you want to join a community that gives you access to the latest forums, publications, fundraising activities and trials? Join “Friends of ANZUP” and connect with people whose lives have been impacted by below the belt cancers, and learn from ANZUP clinical experts and researchers. The “Friends of ANZUP” provides: • Information about clinical trials research and how to access them, • Support from people who understand the challenges of living with prostate and urogenital cancers, • The community magazine, ‘A little below the belt’ featuring: o regular updates and stories from health professionals and researchers, o cancer survivors and cancer trial participants points of view, • Invitation to the annual Community Engagement Forum. Join “Friends of ANZUP” and help us achieve our mission to improve the outcomes and treatment for those living with testicular, prostate, kidney and bladder cancers.

If we can encourage people to ask: “Is there a clinical trial suitable for me?” then we have achieved a major step forward. To find out more visit: or email LITTLE BELOW BELOW THE THE BELT BELT 15 AA LITTLE

Spotlight on prostate cancer

What is prostate cancer? Prostate cancer develops when abnormal cells in the prostate gland grow more quickly than in a normal prostate, and in an uncontrolled manner. Although not always the case, prostate cancers grow more slowly than other cancer types. Prostate cancer is the most common cancer diagnosed in Australia and the third most common cause of cancer death. One in five men will be diagnosed with prostate cancer by the age of 85. It is more common in older men, with 63 per cent of cases diagnosed in those over 65 years of age.

Prostate cancer symptoms The symptoms can include: • frequent urination, particularly at night; • pain on urination; • blood in the urine; • a weak urine stream. More widespread disease often spreads to the bones and gives pain or unexplained weight loss and fatigue.

Causes of prostate cancer Your risk of prostate cancer can be increased by some of the factors below:

In 2018, it is estimated 16,655 new cases of prostate cancer will be diagnosed in Australia.

• age, increasing greatly if you are aged over 50 years;

The five-year survival rate for men diagnosed with prostate cancer is 95 per cent. Nearly all patients who present with localised disease will live beyond five years.

• a diet high in fats and low in fresh fruit and vegetables;

In 2014, there were 3,102 deaths from prostate cancer in Australia. In 2017, it was estimated it would increase to 3,452 deaths.

• family history of prostate, breast or ovarian cancer;

• men of African descent are at higher risk than men of European or Asian descent; • high testosterone levels.

For prostate cancer clinical trials go to page 46

Information derived from Cancer Council Australia;


Q and A

Treatment choices and decision making with Dr Gavin Marx and Rob Palmer At the recent ANZUP Community Engagement Forum, Dr Gavin Marx and his patient Rob Palmer talked about their shared decision making of the treatment choices for Rob’s prostate cancer. The interactive session gave the audience insights into the doctor / patient relationship, decisions that need to be considered and the opportunities that exist with clinical trials as a treatment option. Dr Gavin Marx is a consultant medical oncologist and practices at the Sydney Adventist Hospital and Northern Cancer Institute Frenchs Forest. He is the Clinical Director of the San Integrated Cancer Centre and director of the San Clinical Trials Unit and an Associate Professor at the University of Sydney. Gavin is actively involved in clinical research. He is the principal investigator on a number of trials and has several peer reviewed publications. His particular research interest includes the treatment of prostate cancer. He is actively involved in teaching at undergraduate and post graduate levels. Rob Palmer was diagnosed with very aggressive prostate cancer mid-2014. He was referred to a surgeon and told his best prognosis was to undertake a radical prostatectomy. Following the operation, his regular PSA test showed a spike after six months. This led to a further diagnosis of metastasised prostate cancer through his lymph system. He’s still here. Rob has turned 70, is married with three adult children and lives in Sydney’s lower North Shore. He has retired from a 51-year career in advertising. Rob has a very active retirement regime of golf, tennis, gym, swimming and walking. He has been on the ENZAMET trial for three years.



Dr Gavin Marx Q: What information do you look at when deciding what options to offer your patient?


ARX A: I weigh up many factors, firstly I look at patient factors - general wellbeing, comorbidities, level of fitness and activity and of course their wishes. Then I weigh up tumour related factors -the biology of the disease, what is the nature of the disease how biologically active it is and to what extent has it spread and any other concerns. I will also review what prior treatment the patient may have had as that will put the current situation into context and will influence future treatment options.

So it is a combination of patient factors, biological factors of the tumour itself, prior treatments as well as an awareness of currently available and relevant treatment options for each specific case. Q: Your role as a doctor, explaining patient’s cancer, their options, what each treatment means for them, and what outcomes they will have? A: I think it’s important that the patient comes to the appointment with someone else who will support and listen. An extra set of ears comes in handy. It is important to explain things slowly often with written information to take away and digest the issues as sometimes it can be overwhelming, and it is hard to recall all the details. I often then ask them to come back for a follow up session and to discuss any questions they have. I also try to understand what the patient’s wishes are and make sure they understand the extent of their disease. I make it very clear to them that they have choices and together we weigh up the pros and cons of the various choices. Hopefully by the end of the appointment they have enough information to form choices of what treatment and options are best for them, taking into account all of those factors and options.


Q and A

Q: Your explanation of clinical trials and how they can improve outcomes and treatment of patient’s cancer? A: I see clinical trials as part of a standard treatment and option for patients. I appreciate that not all patients have a disease that is suitable or a trial that is relevant for them, but as with any treatment paradigm that we consider, we should always include consideration of a clinical trial as one of those options if that is appropriate. I always talk to patients about what their standard treatment options are and if there is a suitable trial at my centre or at another centre that is accessible to them. I talk to them about those options and if it would be worthwhile for them to consider. The importance of clinical trials is twofold. Trials are how we improve the outcomes for future patients but I think more importantly it is a way that gives our patients today, an opportunity to access some treatments that they may not be able to otherwise access, which may potentially improve their outcome. Q: When Rob was referred to you, what steps did you take to assist with his decision making process? A: I went through all of Rob’s information from a general overview, his interests, psycho social, general health and if he was fit and well. I tried to get a full understanding of the disease from the biopsies, the surgical reports, reviewing the tumour, any investigations undertaken, the extent of the spread of his disease. Essentially trying to get a clear understanding of the nature and extent of his disease. We discussed the standard treatment options and that there were other options such as a clinical trial. In this case the ENZAMET trial. I provided Rob the patient information sheet for his consideration of the trial. We organised a follow up appointment to go through all the information and make sure he had a good understanding of what was involved in participating on the trial and the opportunity to discuss with his family. Once he felt comfortable and understood the implications we organised for him to sign the forms to get started.

Rob Palmer Q: What information did you look for when you were first diagnosed with prostate cancer? A: I went straight to my GP for information, which he did not provide me. He referred me to his go to ‘best male cancer doctor’ and told me to have my prostate removed. At no stage did I have




the chance to discuss my treatment options, and I wasn’t sure if I had other choices. I had no knowledge of cancer, treatments or clinical trials. Q: What happened after your surgery? A: After my prostate was taken out it was discovered my cancer had metastasised so my surgeon referred me to a radiation oncologist. The radiation oncologist then reviewed my case and due to the cancer spreading to my lymph nodes, referred me to medical oncologist Dr Gavin Marx. Dr Marx went through my options and choices. From there I was put on the ENZAMET trial. Q: What was your first thoughts about going on a trial? A: I jumped at it. I was most excited for an option. I think I felt that being on a trial, was at the cutting edge of treatments and I was given the best shot at getting my cancer under control. My state of mind was pretty freaked out, especially when I heard my prostate cancer had metastasised into my lymph system. It sounded terminal and I thought this could be it. You hear and see positive stories about clinical trials so I was excited to have this option. Four years later I am still here and going strong. Q: What has your experience of the trial been like? A: An extremely positive one from the process, the care, and in particular the level of professionalism from my Trial Manager was very comforting. I knew I was in good hands. Q: What advice would you give other people in a similar situation? A: Absolutely, give it a go. Trials rock, they really do. Q: Any final comments? A: Rob: I also want to add that going into this process can be very daunting and the shock of it can push you down a particular path without seeking all your options or choices. Find as much information as possible, look at the different options and specialists available. Ask questions, understand your cancer and what choices you have. If possible, find a healthcare professional that has a wide understanding of cancer and the treatments /options that are available. Ask questions and get more than one solution if you can and consider a clinical trial.

Q and A

The role of a multidisciplinary team (MDT) A multidisciplinary cancer care team works together to diagnose and develop personalised treatment plans for people with cancer and reviews their treatment during and after completion. The team meet regularly to plan and review treatment for someone with cancer. It means someone with cancer receives care that is personalised, involves a variety of experts, and considers a wide range of life factors. The MDT can consider: • the diagnosis and stage of cancer • available treatment options

What is the ENZAMET trial? Enzalutamide is a new hormone treatment taken as tablets. Previous trials have proven that enzalutamide improves survival and quality of life in men with prostate cancer that has stopped responding to standard hormone treatments and chemotherapy. This large, international randomised trial will determine if treatment with enzalutamide can improve survival, and quality of life, in men starting hormone treatment for newly diagnosed prostate cancer that has spread beyond the prostate. The trial is led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre. There are 1125 men from Australia, New Zealand, Canada, the US, Ireland, and the UK involved in this trial.

• your preferences • the impact of cancer in other areas of your life.

Why are multidisciplinary teams important? Cancer care can be very complicated. There can be a large number of healthcare professionals involved in your diagnosis, treatment and ongoing care. The multidisciplinary team allows all these specialists to work together to plan your care. It reduces the time needed to gather the information about your cancer and develop a treatment plan. MDT’s improve the communication, decision making and coordination necessary for your care.

The trial is now closed to recruitment and the men who participated are being followed up. If you or a member of your family would like to know more about the ANZUP led clinical trials, please discuss with your GP or specialist. You can also contact ANZUP on 02 9562 5042 or refer to the website and search for the trial information

ANZUP brings together a leading multidisciplinary network of oncology, surgical, medical, radiation, nursing, psychology and allied health professionals from within the urogenital cancer field to conduct vital research through clinical trials. If you would like to know more about multidisciplinary teams, please ask your GP or specialist.


Powerful partnership continues the fight against prostate cancer We are delighted to announce ANZUP and the Prostate Cancer Foundation of Australia (PCFA), the peak national body for prostate cancer, have renewed its agreement to work together to fund and implement vital clinical trials in prostate cancer. ANZUP and PCFA have a common interest in clinical trials relating to prostate cancer and have worked in partnership for many years. Both Parties are delighted to continue their strategic partnership . This collaboration has already led to significant outputs with the launch of the TheraP study early this year. Leveraging on our partnership with PCFA, ANZUP opened the TheraP advanced prostate cancer trial in February 2018. This Australianfirst nuclear medicine trial aims to recruit 200 men at 11 sites across Australia. It will compare treatment with the radioactive molecule Lu-PSMA against cabazitaxel chemotherapy for men diagnosed with metastatic castration resistant prostate cancer. The TheraP trial is being led by Michael Hofman, Professor of Nuclear Medicine at the Peter MacCallum Cancer Centre in Melbourne. The TheraP trial is well ahead of schedule in 11 leading centres around Australia.

Movember, Distinguished Gentleman’s Ride, It’s a Bloke Thing and CAN4CANCER. PCFA will continue to be a Platinum Sponsor of the ANZUP Annual Scientific Meeting (ASM) and also host the annual Prostate Cancer Specialist Nursing conference in conjunction with the ASM. We look forward to continuing our partnership as we work together to make a difference to men with prostate cancer.


As well as the ANZUP and PCFA collaboration, the TheraP trial has brought together new partnerships with the Australian Nuclear Science and Technology Organisation (ANSTO), Endocyte, THE THERAP TEAM VISITING THE OPAL REACTOR AT ANSTO

ANZUP welcomes PCFNZ ANZUP is delighted to welcome Prostate Cancer Foundation of New Zealand (PCFNZ) as a research partner. PCFNZ is the national peak body for prostate cancer in New Zealand, and plays a significant role in promoting public awareness of prostate cancer. With over 3000 New Zealand men being diagnosed each year, clinical trial research is a high priority for PCFNZ to improve treatments and outcomes. PCFNZ will enter a 3-year partnership with ANZUP to support clinical trials for prostate cancer in New Zealand, which will include patient support for participation in existing ANZUP studies and other new initiatives.


“Our objective is to improve access to clinical trials for men with both prostate and testicular cancers and we are looking forward to sharing in this venture. We have every confidence this partnership will achieve this objective and Kiwi men, along with all those involved in the trials, will benefit.” Graeme Woodside, PFCNZ CEO


The role of ICECaP in demonstrating economic value by Associate Professor Richard De Abreu Lourenco; Research Fellow with CHERE and the Project Manager for the Cancer Research Economics Support Team (CREST).


We’ve all heard about cases where government funded access to a new medicine or treatment for cancer is delayed awaiting evidence that the treatment works. In many cases, that evidence comes in the form of understanding the long-term impacts on survival and quality of life. This can be problematic for new treatments in prostate cancer, particularly in early stage disease, where we might not have a clear picture of those effects for many years within the confines of clinical trials. New research being undertaken at the Centre for Health Economics Research and Evaluation (CHERE) in collaboration with ANZUP is working on that situation by investigating the use of intermediate measures of treatment effect to determine value for money in prostate cancer care. This research acknowledges that often, rather than waiting for long-term evidence of survival or quality of life, governments and their advisory bodies make decisions about value for money on the basis of intermediate measures. These might be measures such as how many men remain free from their cancer returning or spreading to other parts of the body. One of the key considerations for these decision-making bodies is how much certainty they can have that those intermediate measures reflect what can be expected in terms of longer-term outcomes (e.g. survival). Being confident in the accuracy of the links between intermediate and long-term outcomes is critical if decisions are going to be made about funding new treatments on the basis of early trial evidence – potentially making new treatments available sooner.

Enter the research being undertaken by CHERE, ANZUP and the Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP - https://www.ncbi.nlm.nih. gov/pubmed/26409187) project. ICECaP is a large international project that has focused on the very question of understanding the links between intermediate and longterm outcomes in prostate cancer. To date, it has identified ( ) that being free from metastatic disease at five years is a strong predictor of longer-term survival. The research underway at CHERE is addressing one of the central questions of the ICECaP project; can intermediate outcome measures be used to assess value for treatments in prostate cancer. This is important research that will focus on how we can use intermediate measures of outcomes, like five-year metastasis free survival, to demonstrate to governments that new treatments represent value for money. It will also consider the potential trade-offs that we as a society might consider when deciding between making a treatment available on the basis of intermediate outcomes. The research includes a program of PhD work and related projects, and will involve members of the ANZUP clinical community, members of the ANZUP CAP, government decision-makers and industry partners. This project has the potential to give governments and decision-makers greater certainty in the use of intermediate outcomes when deciding on whether to fund new treatments; certainty that may translate into medicines being made available sooner.

This work is supported by untied funding received from Astellas Pharma Singapore Pty Ltd and Janssen Global, and is coordinated by the ANZUP Cancer Trials Group.


Spotlight on testicular cancer Testicular cancer was once a lethal disease, but is now almost always curable, even when it has spread, because of new treatments tested carefully in clinical trials. We still need to do better. This can only happen through understanding the science and by performing clinical trials to see which treatments are the ones most likely to help.

What is testicular cancer? After skin cancer, testicular cancer is the most commonly diagnosed cancer in men aged 18 – 39. Each year approximately 800 men are diagnosed with testicular cancer in Australia. This equates to 1% of all cancers in men. Germ cell tumours are the most common testicular cancers. Under a microscope there are two main types that are quite different when observed – seminoma and non-seminoma cells. Seminoma cells usually occur in men aged 25-45 but can also occur in men over the age of 60. This form of testicular cancer develops more slowly than non-seminoma cancers. The faster developing, rarer form, of testicular cancer occurs in younger men in their late teens and early 20s. In 2013, 721 new cases of testicular cancer were diagnosed in Australia. For Australian men, the risk of being diagnosed with testicular cancer by age 85 is 1 in 218. The rate of men diagnosed with testicular cancer has grown by more than 50 per cent over the past 30 years, however the reason for this is not known. An estimated 816 cases of testicular cancer were diagnosed in 2017 and a further 828 in 2018. The five-year survival rate for men diagnosed with testicular cancer is close to 98 per cent. In 2014, there were 23 deaths in Australia from testicular cancer.

Testicular cancer symptoms Testicular cancer may cause no symptoms. The most common symptom is a painless swelling or a lump in a testicle. Less common symptoms include: • feeling of heaviness in the scrotum; • swelling or lump in the testicle; • change in the size or shape of the testicle; • feeling of unevenness; • pain or ache in the lower abdomen, the testicle or scrotum; • back pain; • enlargement or tenderness of the breast tissue (due to hormones created by cancer cells).

Causes of testicular cancer An undescended testicle when an infant or family history, that is, having a father or brother who has had testicular cancer, are a couple of factors that may increase a man’s risk of testicular cancer. There is no known link between testicular cancer and injury to the testicles, hot baths, wearing tight clothes or sporting strains.

For other testicular cancer clinical trials go to page 41

Information on Testicular Cancer is derived from Cancer Council Australia


TIGER Trial By Dr Alison Zhang

The TIGER trial will compare standard dose chemotherapy with high dose chemotherapy for people with relapsed germ cell tumours. Germ cell tumours are cancers that have developed from the cells that become sperm. There are two types of chemotherapy given for treatment of germ cell tumours when these cancers progress after first line treatment. Doctors do not know which treatment works best, therefore the TIGER study team wants to compare the treatments to find out more. The TIGER study is a collaboration between the Alliance for Clinical Trials in Oncology (USA), EORTC (Europe), ANZUP (Australia) and the NHMRC CTC. We acknowledge and thank the Movember Foundation for their financial support for this important study.

Trial design This randomised trial, which aims to recruit 420 people, with 60 people to be recruited from Australia and New Zealand. Randomisation means patients will either have standard dose chemotherapy or high dose chemotherapy and stem cell transplant. Neither the patient nor the doctor can decide which treatment is given, although they will know if they end up receiving standard dose or high dose chemotherapy and stem cell transplant.

Treatment Standard dose chemotherapy

The main aims of the trial are to:

Standard dose chemotherapy consists of a combination of chemotherapy called TIP. This consists of drugs, paclitaxel, ifosfamide and cisplatin.

• Determine whether standard dose chemotherapy or high dose chemotherapy and stem cell transplant works best, in particular, in terms of survival

All chemotherapy will be given intravenously. Each cycle of treatment is 21 days. There will be 4 cycles of treatment. This treatment will last approximately 12 weeks in total.

• Determine the side effect profile of these treatments • Learn more about quality of life with these treatments

High dose chemotherapy Treatment consists of: • 2 cycles of paclitaxel and ifosfamide

Who can take part • are male

• Collection of stem cells (very early blood cells in the bone marrow that develop into red blood cells, white blood cells and platelets)

• have a cancer that developed from the cells that become sperm (germ cell tumour)

• 3 cycles of high dose chemotherapy with carboplatin and etoposide

• have either seminoma or non-seminoma cells in the body that started in any part of the body

• A stem cell transplant

The trial is planned to include adolescents and adults who:

• have had treatment with chemotherapy that included a platinum drug called cisplatin but the cancer has come back or has continued to grow • had 3 to 6 cycles of chemotherapy in the first chemotherapy treatment • have satisfactory blood test results • are well enough to be up and about more than at least half the day • are at least 14 years old. The TIGER study is a collaborative study between ANZUP and the NHMRC Clinical Trials Centre, as well as similar groups overseas including the Alliance for Clinical Trials in Oncology (USA) and EORTC (Europe).

Chemotherapy stops the growth of tumour cells in various ways, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving certain chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the bloodforming cells that were destroyed by the chemotherapy. Treatment takes approximately 13-16 weeks in total.

Study visits Everybody taking part is put into 1 of 2 groups at random

Standard dose chemotherapy

High dose chemotherapy

Patients will be required to have a number of tests before starting treatment, including scans and blood tests. Once the allocated treatment finishes, patients will have regular follow-up appointments and check-ups. To find out more go to page 41 or visit



Spotlight on kidney cancer What is kidney cancer? Kidney cancer starts in the cells of the kidney. About 90% of kidney cancers are renal cell carcinomas (RCC). Usually only one kidney is affected but, in rare cases, the cancer may develop in both. Each year more than 3000 Australians are diagnosed with kidney cancer. It makes up about 2.5% of all cancers in Australia. Kidney cancer is rare in people under 40 but risk does increase with age. Also, men are almost twice as likely to be diagnosed with kidney cancer as women. In 2013, there were 3,059 new cases of kidney cancer diagnosed in Australia (1,987 males and 1,071 females). In 2017, it was estimated that 3,512 new cases of kidney cancer would be diagnosed in Australia (2,256 males and 1,256 females). In 2014, there were 920 deaths resulting from kidney cancer in Australia (574 males and 346 females). In 2017, it was estimated that this would increase to 1,049 deaths from kidney cancer (681 males and 368 females).

Causes of kidney cancer The causes of kidney cancer are not known, but factors that put some people at higher risk are: • O besity – Excess body fat may alter certain hormones that can lead to kidney cancer. • S moking – Up to one-third of all kidney cancers are thought to be related to smoking. People who smoke have almost twice the risk of developing kidney cancer as non-smokers. • H igh blood pressure – Whether it is caused by another medical condition or due to being overweight, high blood pressure increases the risk of kidney cancer. • K idney failure – People with end-stage kidney disease have an increased risk of developing kidney cancer. • F amily history – People who have family members with kidney cancer, especially a sibling, are at a greater risk.

The five-year survival rate for Australians diagnosed with kidney cancer is 75 per cent although most people with kidney cancer localised only to the kidney can be cured.

• I nherited conditions – About 3–5% of kidney cancers occur in people with particular inherited syndromes, such as von Hippel-Lindau disease, Birt-Hogg-Dubé syndrome, and hereditary papillary RCC.

Kidney cancer symptoms

• E xposure to toxic substances at work – After regular exposure to certain chemicals, such as arsenic, cadmium or some metal degreasers, the risk of kidney cancer may be higher.

Most people with kidney cancer have no symptoms. Many are diagnosed with the disease when they see a doctor for a different reason. Symptoms may include: • blood in the urine (haematuria); • pain or a dull ache in the side or lower back that is not due to an injury; • a lump in the abdomen; • rapid, unexplained weight loss; • constant tiredness; • fever not caused by a cold or flu.

For kidney cancer clinical trials go to page 43

Information on Kidney Cancer is derived from Cancer Council Australia


The evolution of kidney cancer treatment by Associate Professor Craig Gedye

It is exciting to be able to say kidney cancer treatment is now at a transition point. For a while treatment options for kidney cancer included surgery alone or with radiotherapy. We now have more to offer as a standalone treatment or in combination. Targeted therapies are now being used and target specific molecules in cells to block cell growth. We are now also well aware of the role immunotherapy plays in cancer treatment and are excited to be part of clinical trials for immunotherapy use in kidney cancer. Current trials will allow us to understand how this form of treatment will benefit patients with kidney cancer – both rare and common forms of kidney cancer. Immunotherapy works to enhance the immune system of your body. Cytokines (proteins that activate the immune system) can be given intravenously or orally, and may shrink the cancer. We are eager to explore how immunotherapy can be integrated with existing therapies and current treatment combinations. Clinical trials in immunotherapy allow us to ask questions about this form of treatment with the goal of improving treatments and outcomes. It will hopefully mean rather than searching for and trying anything in the hope that it works we can select treatment that will actually lead to improvements and will work for everyone and not just the lucky few. Developments have been happening in other cancer areas. This biology and precision medicine revolution is now slowly filtering through to kidney cancers. This has taken time as kidney cancer is a strange type of cancer. Unlike other cancer types, kidney cancer does not exhibit a lot of DNA mutations. But when there are one or two critical mutations strange cell growth will occur, the cells will be poorly regulated and metabolism is altered and becomes quite erratic. The clinical trials and ongoing research will allow us to ask questions about these mutations in kidney cancer and provide answers where currently we are still searching. All the research being undertaken suggests we will witness an explosion of treatment activity leading to some people having very positive outcomes from their kidney cancer

treatment. This should lead to a change in focus over the next few years when treating kidney cancer. One clinical trial success story is the UNISoN study. This trial has now been recruiting patients with rare kidney cancer (‘non-clear cell’ cancer) for the past 12 months and is testing immune treatments in two different ways. Firstly, we are investigating how well one immune treatment (nivolumab) works alone. If this is unhelpful by itself, then patients can continue taking nivolumab but also add in a 2nd immune treatment (ipilimumab). This trial will demonstrate how many people will benefit from one drug alone, or from taking both treatments together.

“We hope UNISoN will provide further key pieces of evidence to understand how the immune system works in cancer treatment, and how we can harness that to offer patients with these rarer kidney cancers a unique therapeutic opportunity.’’ Ultimately, trials such as the UNISoN trial will allow us to stop asking if the kidney cancer is a common or rare type of cancer. We will hopefully understand if immunotherapy alone or in combination will work for all kidney cancer types. We might be able to predict who will be helped with current treatments and who will need a different approach. Other trials are being planned to fill further gaps in knowledge and treatment. Eventually a greater array of treatment options will then benefit the patient, especially those with rare forms of cancer, and hopefully become part of the standard of care in Australia. More than 3000 Australians are diagnosed with kidney cancer each year. It makes up about 2.5% of all cancers and is the 10th most common cancer in Australia. Kidney cancer trials are so important and should ultimately provide the ability to say there is a treatment that is right for you.


Spotlight on bladder cancer Bladder cancer is said to be the fourth most common cancer in Australian men, and about 3000 Australians are diagnosed with bladder cancer each year.

What is bladder cancer? Bladder cancer can be described as abnormal cells in the bladder growing and dividing in an uncontrolled manner. Bladder cancer takes different forms: • u rothelial carcinoma, formally known as transitional cell carcinoma, is the most common form of bladder cancer (80-90%) and starts in the bladder wall’s innermost layer in the urothelial cells • s quamous cell carcinoma begins in the flat, thin cells that line the bladder • a denocarcinoma is a rare form which starts in mucus-producing cells in the bladder.

Bladder cancer symptoms The most common symptom of bladder cancer is blood in the urine (haematuria), which usually occurs suddenly and is generally not painful. Other less common symptoms include: • problems emptying the bladder; • a burning feeling when passing urine; • need to pass urine often; • back pain or lower abdominal pain.

Causes of bladder cancer Some factors that can increase your risk of bladder cancer include: • smoking; • diabetes;

The stats

• family history;

In 2013, there were 2555 new cases of bladder cancer diagnosed in Australia. Bladder cancer is common in people aged over 60 and is significantly more common in men than in women. In 2017 there were 2995 cases of bladder cancer diagnosed in men and women combined. This will increase to 3084 in 2018.

• w orkplace exposure to certain chemicals used in dyeing in the textile, petrochemical and rubber industries; • use of the chemotherapy drug cyclophosphamide; • chronic inflammation of the bladder.

In 2014, there were 1040 deaths caused by bladder cancer in Australia. The five-year survival rate for Australians with bladder cancer is 53 per cent. For men, the chance of developing bladder cancer is about 1 in 110, making it one of the top 10 most common cancers in men.

For bladder cancer clinical trials go to page 39

Footnote: Information on Bladder Cancer is derived from Cancer Council Australia


The journey

Mike’s Surf Coast Century assault – the comeback story Mike is 57, lives in Melton Victoria and is married with 3 adult children and 4 grandchildren. His life was about family, running, work and the motor sport club and was pretty healthy until his diagnosis with bladder cancer in December 2016. Priorities have changed a little in the past couple of years with family becoming number one, ‘Living life for them and me, is what’s most important now’. Mike spends more time now with his family, plans more holidays (to NZ, SA, WA to name a few), helps his club prepare for events, enjoys time with running friends and is focusing on improving his fitness – which hopefully will assist with fending off any recurrence of cancer – including some incredible endurance challenges. Mike has a renewed focus on enjoying what life has to offer, including good food, coffee and wine. He has found being part of an ongoing bladder cancer trial has also opened up a new avenue of interest, and opportunities to make a difference, like raising funds for ANZUP in support of the work they do to improve outcomes.

The challenge “For 100km we ran, hiked, walked, didn’t crawl, sooked, cried, laughed, mumbled under our breath, got wet, cold, definitely didn’t get hot, slid our way up and down more than a few hills, saw some wonderful scenery, may have sworn on occasion, almost gave in...but didn’t and got there, after a very long day and night, in the early hours of Sunday morning.”

In 2016 Mike ran his first Marathon and a few months later stepped up to a 50km Ultramarathon at the Surf Coast Century. After Mike finished the 50km, the inevitable discussion about next year occurred. “So 100km next year Mike?” suggested his cousin Sean. “Not bloody likely” was Mike’s retort! Fast forward a few hours and some of their 100km event mates are starting to finish. “So if you do it I’ll do it with you Mick.” “You know what Sean; I reckon it’s doable.” And with that Mike and Sean had decided they’d toe the line together in September 2017 to tackle the Surf Coast Century. In January 2017 Mike was diagnosed with metastatic bladder cancer and by February 2017 had started chemotherapy to try to arrest the progress of the disease. Sean and Mike were still discussing plans for the September assault, not really knowing what would be possible after 6 cycles of treatment over 4 months. Initially, running was possible for Mike a few times a week but by late March and into April, running became brisk walking, however the cumulative effects of chemotherapy reduced the frequency of walking to occasional days out and the odd parkrun. The April start date for the Surf Coast Century 100 (SCC100) training plan came and went and no semblance of Ultramarathon fitness existed for Mike. Chemotherapy finished in late June 2017 and SCC100 2017 rolled around in September. Mike tagged along and supported the crew from Melbourne City Runners (MCR). “So Mike, you here next year and what are you running?” was uttered by more than one MCR member. So here we are, 2018, and the answer was, yes, Mike will be there. Mike’s standard answer to “which event” has been, “the hundred, well that’s plan A, but there’s a plan B and C”... but there’s really only ever been one plan.


The journey

And he did! On Saturday 15 September Mike’s adventures in Ultra Running reached new heights with his first 100km trail run, where he tackled sand, mountains, water, trails, darkness and many other things with his cousin Sean.

rapport with the trial team at Ballarat and look forward to seeing them every 4 weeks, with this passion for the work they do to move cancer treatment forward and an appreciation and support they show for participants in the trials.

Mike completed the Surf Coast Century and raised an incredible $3,177.81 for ANZUP Cancer Trials Group.

Q: What advice would you give other people in a similar situation?

Q: How did you find out you had bladder cancer?

A: I would suggest that you discuss the availability of a trial with your treating doctor and if they suggest that one is available, be open to find out more and if there is one suitable for you and your circumstances, go for it.

A: After passing blood and clots prior to Christmas 2016, I was referred, by my GP, to a Urologist who performed a cystoscopy. The tumour in my bladder was clearly identifiable to him as cancer and a subsequent transurethral resection of bladder tumour (TURBT) and histology of the tumour he had removed confirmed high grade urothelial cancer. Q: What information did you look at when you were trying to decide what to do? A: I used online resources from Cancer Council Australia and other reputable cancer agencies and hospitals, from both here and overseas. Mostly I took advice from my oncologist and urologist. I also sought a 2nd opinion from another urologist. Q: What were your first thoughts about going on a trial? A: We had discussed the possibility of trials at the first consultation with my oncologist but there was nothing available for me. I had also read about treatment options, including trials, in the online resources I consulted prior to that visit and during my treatment. There was always discussion about accessing trials if they became available and I was eligible. I had no hesitation when my oncologist suggested there was a maintenance trial available to me after my treatment was completed. Q: What has your experience of the trial been like? A: My experience has been entirely positive, even though I am on arm B of a randomised trial and not receiving the drug, the standard of monitoring and care is as it would be on the arm receiving the drug. That can’t be bad, at least in my mind. I have a wonderful


Q: How did you hear about ANZUP Cancer Trials Group? A: The Clinical Trials Coordinator at Ballarat Oncology and Haematology, Rosemary, provided a copy of ‘A little below the belt’ magazine for me to read. I was impressed with what I read, and I viewed online after reading, about ANZUP and decided that it was an organisation I’d like to assist. Q: Wow, just wow! Please tell us how you tackled 100km ultra marathon? It must have been a physically and mentally challenging adventure for you? A: With much encouragement from friends and family! It was of course very challenging both physically and mentally. Not comparable to anything else I’ve done, including chemotherapy, which was an entirely different type of challenge. Physically; I probably started to really struggle around 40km, we had some really slippery tracks to contend with about then. We got through to the 50km checkpoint though and seeing our support crew and family lifted my spirits and spurred me on to the next point. Coming to the 70km checkpoint I had decided that I’d pull out as I’d had enough and really didn’t think I could go on, it was dark by now and at times, with just a head torch it was like walking in a tunnel. This was the start of the mental challenge, without a doubt the bigger of the two challenges, because it’s easier to give in to your mind than your body. Our support crew chief came into the course to meet us and walked and talked me through to 70km. A vegan cheese toastie (amazing!)

The journey

and some banter with the support crew at the 70km aid station lifted my spirits again and off we marched to the next checkpoint and made that just before cut off. Onwards again, with fresh shoes and socks. I was a little distraught at the next checkpoint though as I thought we’d missed the cut off time. Turns out our crew chief was just encouraging us to get there with time to spare by telling us an earlier due time than the actual due time! I swore a little, or maybe a lot, when I found out.

Q: Any future challenges on the horizon for you. A 200km ultra marathon? A: Ha-ha! Not at the moment, I’ve recovered really well from the 100, but haven’t set any goals for another event, yet. Maybe a few half marathons and a trail marathon? I’ve always got my eye on the running calendar so I’m sure something will pique my interest in the New Year. Anything less than 100km wouldn’t seem like a challenge though would it?

From 70km onwards there was really no question in mind about finishing, after the crew chief pep talk, it was always going to happen. He’d reminded of what I’d come through to get there since my diagnosis and this experience was really just a walk in the park in comparison. After that, I just decided I wasn’t going to give in to the mental demons and it was onwards to the finish. Q: What was the highlight of the Surf Coast Century Assault? A: Without a doubt the finish, not just because I’d made it, but because so many people were there to greet me at the finish. It was 4:00am and my wonderful family and friends were there for me and my daughter was the first to greet me as I crossed the line, which was very emotional.



What is on the horizon for bladder cancer? by Professor Dickon Hayne Bladder cancers often start in just the superficial lining of the bladder. Early on it can be treated and cured by removal. However, if the cancer spreads to other parts of the body then it is usually not curable, although it can respond to available treatments. We need to develop better treatments and this involves performing clinical trials. BCG + Mitomycin is a clinical trial being undertaken by ANZUP in collaboration with the NHMRC (CTC). The trial contains two stages – the first with 130 patients and the second stage with 370 patients. It is an open-label trial meaning both the researchers and participants know which treatment is being given. This is a phase 3 trial so is being undertaken to determine effectiveness and safety in a larger number of people in comparison to existing treatment options. The BCG + Mitomycin trial began in 2013 and phase 3 trials often take several years to complete. This large-scale, randomised trial will determine the effects of adding mitomycin to BCG on cure rates, survival, side effects, and quality of life. Using both drugs, they can be put into the bladder to stop bladder cancer coming back or progressing further. This trial tests the most promising and readily available intervention (adding mitomycin to BCG therapy) for reducing the progression of high risk early bladder cancer (high risk non-muscle invasive bladder cancer (NMIBC)). If this new intervention is effective, it would reduce deaths from bladder cancer, reduce the need for complete surgical removal of the bladder and improve quality of life. Furthermore, the new combination of drugs tested in this trial will likely become adopted as the standard of care in Australia and internationally.

Whilst other work has suggested adding mitomycin to BCG therapy might be effective, this trial will provide the first and only high quality test of this theory. This trial has already established Australia’s first collaborative network of urologists conducting trials in NMIBC and is Australia’s first large scale clinical trial for the treatment of NMIBC. This trial is the only multicentre investigator initiated NMIBC trial in Australia. This ANZUP investigator initiated study is being funded by Cancer Australia. We also acknowledge Omegapharm and Merck Sharp & Dohme for providing study drugs. The ACCEPT cystectomy database is open at West Australian sites, and is in the process of opening at multiple sites in other states. Removal of the bladder as treatment for bladder cancer may be necessary to cure the disease. However, this remains one of the major procedures performed by urologic surgeons and carries significant risks for patients. Despite this, there is currently a lack of quality research to identify ways to improve patient outcomes. The purpose of this study is to set up Australia’s first national secure online database to allow investigators to analyse treatments currently used by urologists and their associated outcomes and complications after bladder removal. This information will then be used to formulate future randomised controlled trials. This will hopefully provide a platform not only for valuable data collection, but also multicentre interventional trials to be planned.

For more information on bladder cancer clinical trials go to page 38


Patient experience of participating in an ANZUP clinical trial by Natasha Roberts

I am a nurse working as a clinical trial coordinator. Many of my patients are on ANZUP clinical trials. It has been a privilege looking after patients and their families attending our clinics, and it is very easy to develop close relationships over the course of a clinical trial. I have always wondered what it is like for patients who choose these therapies on clinical trials. This is why I applied for a grant to fund a study to describe the perspectives of the patient on a clinical trial. Having been awarded funding from ANZUP, I have started undertaking interviews with patients so I can qualitatively describe what this experience is like.

There are many phases of a clinical trial and many decisions are made along the way. Our research should hopefully allow us to understand more the clinical trial journey and decision-making process.

A clinical trial is a research study that aims to measure whether a new treatment is better than the care we already have available in our healthcare system. How this is conducted is very prescriptive and closely regulated to make sure the patient stays safe, and the results are accurate. As a clinical trial coordinator, we are responsible for making sure this happens.

• How do you feel when you are randomised on a trial?

We don’t have a lot of research on what it is like to participate in a clinical trial. There are some studies, but none with genitourinary and prostate cancer patients. As a result there are a lot of questions currently unanswered: • W hat is it like when you find out about a potential clinical trial treatment option?

• W hat is it like having to follow a strict protocol of assessments and treatments? • What is life like when treatment is finished? Our study aims to gather an accurate description of these experiences so we can stress the importance of being aware of the patient experience, expectations and the information communicated. This study also has scientific advantages. Firstly, it is important health professionals know as much as possible so they can better support the patient and their families. Secondly, this study will help to ensure the right resources are available in health services that conduct clinical trials. Most importantly, this research will allow us to write protocols that properly take into consideration the day-to-day life of the patient and how clinical trials impact on everyday occurrences. Clinical trials are an important part of the health care system in Australia, so it is important they are designed to maximise outcomes for the patient. The best way to do this is to know what it is like for the patient and have strong evidence to guide future care.


Education and Innovation


Practical advice for dealing with cancer with expert opinions and survivor insights Since we last caught up with Joe Bakhmoutski from Simplify Cancer in the July edition of this magazine, he has produced another 13 podcast episodes with cancer survivors, medical experts and support specialists, who know exactly what cancer is like firsthand. Joe is now developing a series of videos that share practical advice on dealing with cancer: Through his own personal journey with testicular cancer, Joe has developed Simplify Cancer to make sure you don’t have to do it alone, and it is growing every day with resources, tools and followers. Joe is simply providing invaluable tools to increase mental strength and resilience when people are facing cancer. In the last six months Joe has interviewed ANZUP Chair Professor Ian Davis, Professor of Medicine and Head of the Eastern Health Clinical School at Monash University, on ‘What you must know about clinical trials before starting treatment’. Joe’s no holds barred interview with Ian tackles all the tough questions you’ve ever wanted to ask about clinical trials. Including • The guinea pig myth • Are clinical trials safe? • When is placebo given (if at all) • Clinical trials as decision support tools • Why you should ask about one now


Excerpt from podcast Joe: Ian, it’s such a pleasure to meet you and to talk to you about clinical trials. I’m really excited about it because to me, really, clinical trials are the front line to fighting cancer. It’s making a huge difference for folks out there. Unfortunately, most people don’t realise how important this is and the critical role it plays in fighting cancer. What’s your perspective on that? Ian: Yes, thanks, Joe, for the chance to talk to you and to talk about clinical trials. It’s very important. Every time you go to your doctor to get your blood pressure medication, or the medicine for your cholesterol, or even if you’re going to go and buy some vitamins from the chemist and you think that’s going to help you, you do that because you got some information about it. You know that, here is a treatment that might help you in your condition or might not. You’ve got information about how safe it is. When

Education and Innovation you should use it and when you shouldn’t use it. You might not be aware you got that information but it’s there. That exists because clinical trials have been done in all of those situations. Every time you go to the doctor and you have cancer and you’re having a discussion about what sort of treatment might be appropriate for you, the advice that’s being given to you is being given in the context that a clinical trial has been done and it’s given you evidence. Now, we hope that that’s the case. The reality is, for many of the clinical situations we find ourselves in, the evidence is not there, we’re extrapolating from what we know or from the basic science, or from our understanding of the condition but there might not be a clinical trial to guide us in decision-making. In that situation, it becomes a whole lot harder to make recommendations for people. That’s why we need to continue to push this agenda of doing more clinical trials, doing them better, so that we can get more information, help people, and support them in their decision-making. To listen to the entire podcast, go to: In episode 37 - making better decisions about treatment and life beyond, ANZUP’s Quality of Life Subcommittee Chair and Senior Research Fellow at the University of Sydney’s School of Psychology, Dr Haryana Dhillon, discusses better ways of dealing with cancer, from the time of diagnosis to life after treatment. In this podcast, Joe and Haryana cover: • Why a patient’s voice needs to be an integral part of clinical practice • Clinical trials and what they can do for you • Making decisions around treatment • Tips to prepare for your specialist appointment

Haryana: I think really one of the biggest misconceptions is that clinical trials are only offered at the end of life, or when all other treatments options have been exhausted. That’s really a big problem for us to try to overcome. We want people to understand that we have trials right through from prevention of cancer to surgical procedures and supported care, as well as all of the other treatments that might be relevant to someone. The critical thing about it is that this is actually a really good way that you can ensure that you’re getting the best supportive care, or the best treatment options. When we do particularly randomised clinical trials, we’re comparing a new or different sort of treatment that we think might be better than the standard treatment to what might be considered the best standard care. That standard of care is agreed on by all of the clinicians who take part in the study in the group and who are members of the group. You can be certain that you’re getting the best treatments that you would be offered outside of the clinical trial, as well. Plus, the fact that you also often have slightly more frequent monitoring visits and followup because we wanted to see and track how you are performing or how the trials are going, the treatments that we’re looking at and how the trials are going. You have regular contact with your clinician and the research team that help to support them in the hospital, as well. You get a big team as part of your care, in addition to the cancer doctors who would normally be looking after you. They’re two kinds of things that are important to understand. I guess the other thing is that there are lots of headlines and news about miracle breakthroughs and cures for cancers and things like that that we see, often, they’re headlines that are based on headlines before we’ve even tried some of these treatments in people. Actually, the time that it takes for us to do a clinical trial and demonstrate the impact on the cancer developmental growth and then even later on, people’s long-term survival outcomes are things that usually take years for us to be able to do. Sometimes we may not have the answer to a clinical trial for three or five or ten or even fifteen years after it starts. It’s a really long-term investment on the part of the clinicians and the health professionals and the patients, as well, in terms of making sure that we get all of that relevant data. To listen to the entire podcast, go to

Excerpt from podcast Joe: Tell me, with respect to doing clinical trials, what are, in your opinion, some of the biggest myths and misconceptions that people have about going through a clinical trial?

To find out more about Simplify Cancer and to listen to the podcasts go to


Education and Innovation

Clinical trials awareness campaign

Is there a trial for me? As part of its strategic plan, ANZUP is committed to increasing engagement with patients, their carers, consumers and the broader community to promote the importance of clinical trial research in below the belt cancers. To do this successfully, ANZUP needs to challenge the many myths and misconceptions among the general public surrounding clinical trials. Even for patients, there can be a lack of understanding on how trials work. What patients take away from their doctor can be different from what clinicians think they have understood. ANZUP has partnered with Breast Cancer Trials (BCT) to produce a new video to help educate the public and tackle the misconceptions about clinical trials. The video features Professor Fran Boyle AM and members of the ANZUP and BCT Consumer Advisory Panels and trial participants, Cheryl Grant and Les Land. Thanks to the generous support of Tonic Health Media, the 60 second campaign video was shown on the Tonic on demand network in over 1,900 GP waiting rooms around Australia during July and August 2018, with the aim to prompt patients to ask, ‘is there a clinical trial for me?’ Tonic Health Media’s research indicates average wait times in GP clinics of 30 minutes with 71% of patients reporting they had watched Tonic TV and 22% asking their GP about the content they had seen on screen. As part of the campaign, a post evaluation was conducted to see how the clinical trials awareness campaign was viewed by the patients and their carers.








More than 50% of viewers said the advertising changed the way they thought about clinical trials Due to the positive feedback from the campaign, ANZUP will be re-running the video throughout December and January. If you happen to be visiting your GP in this time, watch out for the video and let us know what you think.

Education and Innovation

Celebrating five years, changing the face of cancer On Monday 5 November 2018, the Chris O’Brien Lifehouse celebrated five years in operation. The day was commemorated with an open day providing information stalls, education sessions, tours and entertainment. ANZUP was delighted to join the prostate cancer Lifehouse team with a stall at the open day, which included information on prostate cancer, clinical trials and support services. There was even a quiz – guess the urogenital anatomy. It was a great day to highlight the work we are doing together to improve outcomes for below the belt cancers through research. THE ANZUP AND LIFEHOUSE TEAMS

Australian medical research delivers outstanding returns on investment A new report by KPMG, ‘The Economic Impact of Medical Research in Australia’, shows that Australian medical research delivers an outstanding return on investment to the Australian economy. Another reason why clinical trials matter - for health and wealth.



invested in medical research



in benefits to the population6

$78B in net gains

Medical research makes a significant economic contribution that extends well beyond the life-changing health outcomes for individuals. Medical research creates jobs and a larger, more productive workforce by improving the health and well-being of the population. A healthier population has a wider flow-on impact in other industries across the economy. Medical research from 1990 to 2004 has delivered net present gains of $78 billion, $52 billion in health gains and a further $26 billion in wider economic gains.


to the Australian economy



health gains


wider economic gains

To read the entire report go to Note: Images derived from Association of Australian Medical Research Institutes


Make a difference with ANZUP We need your help to improve outcomes for people affected by these below the belt (prostate, testicular, bladder and kidney) cancers and for future generations. Any donation, large or small, goes straight into the hands of experts to find the answers we need.

To find out more or to donate please go to

Fundraise for ANZUP

If you are interested in holding an event to support ANZUP or are considering joining an event such as the City 2 Surf, Run Melbourne, Sydney Marathon, Walk to Work Day or any other community event, please contact us at or call 02 9562 5042 and we will help you set up the fundraising pages. 100% of every donation made to ANZUP goes towards clinical trial research to improve outcomes for bladder, kidney, testicular and prostate cancers.

ANZUP is a not for profit cancer research charity and is registered on the Australian Charities and Not-for-profits Commission (ACNC) Register and the Charities Services Register in New Zealand. We have obtained Deductible Gift Recipient (DGR) status in all states and territories in Australia and donee status in New Zealand. This means donors can claim income tax deductions for gifts to ANZUP (of $2 or more in Australia and $5 or more in New Zealand) in their income tax returns. 36 A LITTLE BELOW THE BELT

Current ANZUP trials If you would like to know more about any of these trials, please discuss with your GP or specialist.

Bladder cancer

Testicular cancer

Prostate cancer

ANZUP Trials

ANZUP Trials

ANZUP Trials

l BCG + MM


l TheraP


l P3 BEP

l Pain Free TRUS B

Co-badged Trial l NMIBC

Kidney cancer ANZUP Trials

Trials now closed to recruitment





Co-badged Trial l FASTRACK II

l BL12 l e-TC 2.0 l proPSMA A LITTLE BELOW THE BELT 37

Current ANZUP trials

Bladder Cancer BCG + MM Trial

Non-muscle invasive bladder cancer is common and causes substantial suffering. It requires removal or irradiation of the bladder within five years in more than 30 per cent of people with high-risk tumours, despite best current treatment. Recent preliminary studies show promising results from adding mitomycin (MM), a chemotherapy drug, to current treatment with BCG (bacillus calmette-guerin – a strain of modified bacteria which stimulates an immune response to early cancer cells). This randomised trial will determine the effects of adding MMC on cure rates, survival, side effects and quality of life. This could potentially provide a simple and cost-effective treatment for patients who suffer from this cancer. It is anticipated that 500 patients will be enrolled in the study in Australia and New Zealand. To date 186 patients have been recruited from 13 sites. This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know. For more information, please go to the trials page on the ANZUP website: au/content.aspx?page=trials-bcgmmc. ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC). This ANZUP investigator initiated study is being funded by Cancer Australia. We acknowledge Omegapharm and Merck Sharp & Dohme for providing study drugs.


Current site locations for the BCG + MM trial: NSW • Concord Repatriation General Hospital • Northern Cancer Institute • Southside Cancer Care Centre • Sydney Adventist Hospital Clinical Trials Unit • The Tweed Hospital • Westmead Hospital VIC • The Alfred Hospital • Austin Hospital • Epworth HealthCare (Richmond) • Footscray Hospital • Frankston Hospital • Royal Melbourne Hospital WA • Fiona Stanley Hospital

Current ANZUP trials

Bladder Cancer PCR MIB Trial

Opened in mid-2016, this trial is aimed at managing bladder cancer that has spread into the wall of the bladder. A combination of chemotherapy and radiotherapy is the current standard treatment. This study aims to assess if it is safe and effective to add an additional new drug called pembrolizumab to the standard therapy of chemotherapy and radiation therapy. Pembrolizumab is a new treatment that “takes the brakes off” the immune system, allowing it to attack cancers more effectively. Studies of pembrolizumab in widespread bladder cancer have shown benefit, with cancer shrinkage observed in about two thirds of people, and in some cases long periods of disease control. At present, pembrolizumab, is approved for use in Australia for the treatment of advanced melanoma in adults.

Current site locations for the PCR MIB ANZUP clinical trial: NSW • Chris O’Brien Lifehouse • Prince of Wales Hospital • Royal North Shore Hospital VIC • Austin Hospital WA • Sir Charles Gairdner Hospital

It is expected that it will take two years to accrue the required 30 patients. To date, we have five sites active and 9 patients have been recruited. Please speak with your doctor if this is of interest to you or someone you know. For more information, please go to the trials page on the ANZUP website: aspx?page=trials-bladder.


Current ANZUP trials

Bladder Cancer Co-badged trial NMIBC-SI Evaluation

Non-muscle invasive bladder cancer (NMIBC) makes up approximately 70-80% of all bladder cancer diagnoses. Treatment is generally intended to reduce the risk of the bladder cancer recurring or progressing to muscle invasive disease. Treatment involves endoscopic resection to the bladder tumours followed by potential intravesical chemotherapy or immunotherapy. Although treatments can significantly reduce the risk of recurrence and progression, there are both benefits and harms that are likely to vary between treatment options. However, little is known about the impact of these treatments on patients’ quality of life.

Current site locations for the NMIBC-SI trial:

This project follows on from Phase I, which involved qualitative research to develop a draft Non-Muscle Invasive Bladder Cancer Symptom Index (NMIBCSI). The aim of the current project is to evaluate the psychometric properties of the NMIBC-SI. This will be conducted across two field tests:

• Monash Medical Centre - Clayton

• Field Test 1 is a cross-sectional study design asking participants to complete the draft NMIBC-SI questionnaire either on paper or electronically. The purpose of Field Test 1 is to produce a shorter version of the NMIBC-SI by eliminating items with poor psychometric properties.


• Field test 2 uses a prospective longitudinal study design to evaluate the clinical validity of the final version of the NMIBC-SI. Participants will be asked to complete the NMIBC-SI along with comparative questionnaires at different time-points during their treatment. The purpose of Field Test 2 is to assess the reliability, validity and responsiveness of the final version of the NMIBC-SI to ensure it is fit for purpose in clinical research. This study is currently active and recruiting. Field Test 1 enrolled 220 patients and is now closed. Field Test 2 is currently active and has recruited 27 patients. Please speak with your doctor if this is of interest to you or someone you know. For more information, please go to the trials page on the ANZUP website: ANZUP collaborates with Cancer Australia and Cancer Council NSW. This study is being sponsored by the University of Sydney.


NSW • Concord Hospital • Royal North Shore Hospital • Westmead Hospital • Westmead Specialist Centre VIC • Austin Hospital • Royal Melbourne Hospital WA • Fiona Stanley Hospital

• Mater Hospital Brisbane New Zealand • Cantebury Urology Research Trust • Tauranga Urology Research Ltd USA • Mayo Clinic • University of Minnesota Hospital • University of Kansas

Current Current ANZUP trials ANZUP trials

Testicular Cancer Testicular Cancer/Germ Cell Tumours TIGER Trial

This randomised phase III trial will study how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumours that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumour cells. They either kill the cells by stopping them from dividing or stop them from spreading. Giving chemotherapy before a stem cell transplant halts the growth of cancer cells by stopping them from dividing or by killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Current site locations for the TIGER trial: NSW • Chris O’Brien Lifehouse QLD • Princess Alexandra Hospital VIC • Box Hill Hospital • Peter MacCallum Cancer Centre INTERNATIONAL • Sites open in the USA, EORTC and UK

It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumours. Up to 420 patients will be enrolled in Australia, New Zealand and other countries. Currently we have 4 sites open in Australia and New Zealand, and 2 patients enrolled. This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know. ANZUP is collaborating with the Alliance for Clinical Trials in Oncology (USA) and EORTC (Europe) and the NHMRC Clinical Trials Centre. For more information, please go to the trials page on the ANZUP website: aspx?page=testicularcancertrialdetails.


Current ANZUP trials

Testicular Cancer Testicular Cancer/Germ Cell* Tumours PHASE III Accelerated BEP Trial The current standard practice for the treatment of germ cell tumours is the use of the chemotherapy combination called BEP, which consists of three chemotherapy agents – Bleomycin, Etoposide and Cisplatin – administered on a threeweekly cycle. BEP is given with a drug called pegylated G-CSF (or pegfilgrastim) that stimulates white blood cell production. The purpose of this study is to determine whether giving the same dose of BEP on a two-weekly schedule will be more effective and better tolerated than a threeweekly schedule. The two-weekly schedule is called “accelerated BEP” and the three-weekly schedule is called “standard BEP”.

This ANZUP investigator initiated study is being funded by Cancer Australia.


Current site locations for the P3BEP ANZUP clinical trial:



• Christchurch Hospital

• Calvary Mater Newcastle • Chris O’Brien Lifehouse • Concord Repatriation General Hospital • Macquarie Cancer Clinical Trials • Prince of Wales Hospital • Royal North Shore Hospital • SAN Clinical Trials Unit • The Tweed Hospital • Westmead Hospital

This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

• Royal Adelaide Hospital

ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC).


• Auckland Hospital • Dunedin Hospital • Palmerston North Hospital • Starship Children’s Hospital International Sites are open in the UK and USA

• Nepean Hospital

Up to 500 patients will be enrolled in the study in Australia, New Zealand and other countries. Currently we have 26 sites open in Australia and New Zealand, and 67 patients enrolled. We have also set up the trial in Ireland with the support of Cancer Trials Ireland and the Medical Research Council, Cambridge University, UK.

For more information, please go to the trials page on the ANZUP website: au/content.aspx?page=testicular cancertrialdetails

• Fiona Stanley Hospital

QLD • Princess Alexandra Hospital • Royal Brisbane & Women’s Hospital SA • Flinders Medical Centre

TAS • Royal Hobart Hospital VIC • Austin Health • Border Medical Oncology • Box Hill Hospital • Peter MacCallum Cancer Centre • Sunshine Hospital

ANZUP has been awarded funding from the Sydney Catalyst Translational Cancer Research Centre for the Phase III Accelerated BEP translational sub-study. This will involve the collection of blood and tissue.

Current Current ANZUP trials ANZUP trials

Kidney Cancer KEYPAD

Renal cell carcinoma (RCC) is the 9th most common cancer in Australia and the 10th most common cancer in Western populations. Approximately 75% of kidney cancers are clear-cell renal cell carcinomas (ccRCC). At the moment up to half of patients with clear cell renal carcinoma will die of their cancer.

Current site locations for the KEYPAD clinical trial:

Immune therapies have been shown to be effective in about a quarter of patients with clear cell renal cell carcinoma after the standard treatment (sunitinib) has failed.

• Macquarie University Hospital

This study will test if a drug frequently used to treat osteoporosis, (thinning of the bones), can team up with immune therapy to improve survival and increase the chance of the cancer shrinking for people with clear cell kidney cancer.


In the trial, people with advanced clear cell kidney cancer will be offered treatment with two antibodies (a type of protein). This trial will investigate if these drugs taken together can increase the ability of the body’s immune system to attack kidney cancer cells. It is hoped that by combining pembrolizumab with denosumab, (another antibody which is used to help reduce bone loss in osteoporosis and cancer patients), the immune system will be stimulated, so that the immune therapy will work better in the tumours.

NSW • Calvary Mater Newcastle • Concord Repatriation General Hospital

• Northern Cancer Institute • St George Hospital

• ICON Cancer Care • Royal Brisbane & Women’s Hospital • Sunshine Coast University Hospital VIC • Box Hill Hospital • Monash Health Clayton • Peter MacCallum Cancer Centre • Ballarat Oncology and Haematology Services SA

The study is a collaboration between ANZUP and the NHMRC Clinical Trials Centre, in partnership with MSD and Amgen.

• Flinders Medical Centre

This study is currently active and recruiting. To date 14 sites have been activated in Australia with further sites to be added and a total of 70 patients to be recruited.

• Fiona Stanley Hospital


For more information, please go to the trials page on the ANZUP website: aspx?page=kidneycancerfastrackiitrial


Current ANZUP trials

Kidney Cancer UNISoN

In this clinical trial ANZUP will test whether new immune treatments can help people with rare kidney cancer (‘non-clear cell’ cancer). Non-clear cell represents approximately 25% of people with kidney cancer; and because it is rare there are no treatments currently reimbursed in Australia. The UNISoN trial will test immune treatments in two different ways; firstly the trial will investigate how well one immune treatment (nivolumab) works alone. If this is unhelpful by itself, then people can continue taking nivolumab but also add in a 2nd immune treatment (ipilimumab). The trial will also discover how many people will benefit from one drug alone, and by doing detailed laboratory testing of people’s cancer samples, hope to also learn who will only benefit from taking both treatments together. Nivolumab and ipilimumab have been used alone or together in many cancers, so the side-effects are well known and should be manageable. Immune treatments help some people with cancer, especially those with melanoma, common (clear cell) kidney cancer, lung and bladder cancer. Unfortunately they are much less effective in other cancers (like pancreas, prostate and brain cancers). Nivolumab and ipilimumab have not been tested in people with non-clear cell kidney cancers, so ANZUP is delighted to ask this question, and hopes to help people with this rare disease. This study is currently active and recruiting. To date 19 sites have been activated in Australia with further sites to be added.

Current site locations for the UNISoN trial: NSW • Border Medical Oncology • Calvary Mater Newcastle • Campbelltown Hospital • Chris O’Brien Lifehouse • Northern Cancer Institute • Port Macquarie Base Hospital • Prince of Wales Hospital • St George Hospital • St Vincent’s Hospital • Tamworth Hospital • Westmead Hospital VIC • Ballarat Oncology & Haematology Service • Box Hill Hospital • Monash Health - Clayton SA • Adelaide Hospital/ Ashford Cancer Centre Research • Flinders Medical Centre QLD • Royal Brisbane and Women’s Hospital • Sunshine Coast University Hospital WA • Fiona Stanley Hospital

We acknowledge BMS for providing the study drug. For more information, please go to the trials page on the ANZUP website: content.aspx?page=kidneycancerfastrackiitrial


Current ANZUP trials


Surgery is the standard treatment for primary kidney cancer. However, in some cases, surgery is either not possible or other health problems make surgery high risk. This study involves a relatively new, highly precise multidirectional radiotherapy technique called Stereotactic Ablative Body Radiotherapy (SABR) which will be applied to all participants. The aim of the study is to test the ability of the technique to control cancer within the kidney for those people for whom surgery is not an option, and to examine the side effects of the treatment, including how it may affect your kidney’s function.

Current site locations for the FASTRACK II trial: NSW • Calvary Mater Newcastle • Liverpool Hospital • Royal North Shore Hospital VIC • Peter MacCallum Cancer Centre • The Alfred (William Buckland Radiation Centre)

This study is currently active and recruiting. To date 8 sites have been activated in Australia and New Zealand, with 40 patients recruited.


For more information, please go to the trials page on the ANZUP website: aspx?page=clinicalkidneycancertrials


ANZUP collaborates with the Trans-Tasman Radiation Oncology Group (TROG).

ANZUP ClinTrial Refer In July 2014 ANZUP released its first trial based app. Although designed for specialists, it is also a very useful tool for patients and carers. This searchable app allows you to find clinical trials by:

• Royal Adelaide Hospital

• Princess Alexandra Hospital • Royal Brisbane and Women’s Hospital

To download the free app, please visit: • Apple iTunes: clintrial-refer-anzup/id894317413?mt=8

• disease (cancer type)

• Google Play:

• h ospital locations where patients are being recruited details?id=com.lps.anzup

• c linical trial status (i.e. are sites actively recruiting or are they closed)

• Or go to the App/Android store and type in ANZUP

• i nclusion/exclusion criteria (i.e are you suitable for the trial).


Current ANZUP trials

Prostate Cancer TheraP

Lutetium-177 PSMA radionuclide therapy (Lu-PSMA) is a new treatment for advanced prostate cancer. Lu-PSMA is a radioactive molecule that specifically attaches to cells with high amounts of PSMA on the surface of the cells. This allows the radioactivity to be delivered mainly to the prostate cancer cells wherever they have spread, while sparing most normal tissues. Previous small studies of Lu-PSMA showed promising activity in patients with advanced prostate cancer. This randomised study will compare Lu-PSMA with a type of chemotherapy called cabazitaxel, which is the standard treatment for advanced prostate cancer when other treatments have stopped working. Half the participants will receive Lu-PSMA and half will receive cabazitaxel. This study will provide further information about the risks and benefits of Lu-PSMA compared with cabazitaxel in men with prostate cancer.

Current locations for the TheraP trial: NSW • Calvary Mater Newcastle Hospital • Liverpool Hospital • Royal North Shore Hospital • St Vincent’s Hospital VIC • The Austin Hospital • Monash Medical Centre – Moorabbin of Monash Health • Peter MacCallum Cancer Centre SA • Royal Adelaide Hospital

We plan to enrol 200 participants in the study in Australia.


This trial is open and has recruited 95 patients to date. If you are interested in participating in the trial, please refer to aspx?page=trials-prostate

• Royal Brisbane and Women’s Hospital

TheraP is a partnership between ANZUP Cancer Trials Group and the Prostate Cancer Foundation of Australia (PCFA) with support from the Australian Nuclear Science and Technology Organisation (ANSTO), Endocyte, It’s a Bloke Thing, Movember and CAN4CANCER.

• Sir Charles Gairdner Hospital


WA • Fiona Stanley Hospital

Current ANZUP trials

Prostate Cancer Pain Free TRUS B

A prostate biopsy involves taking small pieces of the prostate through a needle so that it can be looked at through a microscope. A Trans Rectal Ultrasound (TRUS) guided biopsy is the usual method and involves insertion of a thin needle through the wall of the rectum into the prostate using the guidance of an ultrasound probe. An injection of a local anaesthetic (lignocaine) around the prostate is the standard method of reducing the discomfort of a prostate biopsy. Methoxyflurane (Penthrox ) is a drug given with a simple inhaler and is widely used by first-aid services to reduce pain. This randomised trial will determine if the discomfort of prostate biopsies can be reduced by giving men inhaled methoxyflurane in addition to their standard injections of local anaesthetic.

Current locations for the Pain Free TRUS B trial: NSW • Westmead Hospital VIC • The Alfred Hospital • Casey Hospital


This is a phase 3 double-blind placebo-controlled randomised trial of methoxyflurane with peri prostatic local anaesthesia to reduce the discomfort of trans rectal ultrasound-guided prostate biopsy.

WA • Fiona Stanley Hospital New Zealand • Canterbury Urology Research Trust • Cardinal Points Research • Tauranga Urology Research

This study will include 420 men. Currently we have 7 active sites across Australia and New Zealand with 312 patients participating. ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHRMC CTC). This trial is open and recruiting. If you are interested in participating in the trial, please refer to au/content.aspx?page=trials-prostate This ANZUP investigator initiated study is being funded by Cancer Australia. We acknowledge MDI for providing the study drug.


ANZUP trials in follow up

Trials in follow up

Once a clinical trial is finished, researchers scrutinise all the information collected during the course of the study. Reviewing all the data allows researchers to decide whether the results mean the new intervention should continue to the next phase of clinical trial, or, when applicable, seek approval for broader use by the appropriate authorities. Once a new intervention has been proven to be effective and safe, it may become part of standard treatment for the condition or disease. Review and analysis of the information can take an extended period of time. So there may be a delay before the results of a clinical trial are known. This is definitely the case with larger trials that can involve thousands of people from many hospitals both in Australia and overseas. In large multi-centre trials the examination of the data and outcomes may take place over several years. If you have taken part in a trial and specified you wish to know the overall results of the trial, the researchers should make them available to you directly. Usually results of all completed studies will also be made available in papers or reports published in scientific journals.

ANZUP now has five trials in follow-up: • ENZAMET • ENZARAD • BL-12 • E-TC • proPSMA

ENZARAD ENZARAD is a randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer. Enzalutamide is a new hormone treatment taken as tablets. Previous trials have proven that enzalutamide improves survival and quality of life in men with prostate cancer that has stopped responding to standard hormone treatments and chemotherapy. This large, international randomised trial will determine if treatment with enzalutamide can improve survival and quality of life in men starting radiation and hormone therapy for prostate cancer that does not seem to have spread beyond the prostate. The trial has been led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre. The trial accrued 802 men from 69 sites across Australia, New Zealand, Canada, the US, Ireland, and the UK. Recruitment closed on 30th June 2018.

ENZAMET ENZAMET is a randomised phase 3 trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer. As with the ENZARAD study the drug being tested in this study is enzalutamide, a new hormone treatment taken as tablets. Previous trials have proven that enzalutamide improves survival and quality of life in men with prostate cancer that is no longer responding to standard hormone treatments and chemotherapy. This large, international randomised trial will determine if treatment with enzalutamide can improve survival and quality of life in men starting hormone treatment for newly diagnosed prostate cancer that has spread beyond the prostate. This trial has been led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre. A total of 1,125 participants from 83 global sites from Australia, New Zealand, Canada, the US, Ireland, and the UK have taken part in this trial. Recruitment closed 25th March 2017 and the current estimated time for 1st interim analysis is Q1 2019.


ANZUP trials in follow up

Trials in follow up



This study was designed to look at whether NabPaclitaxel improves survival and is less toxic, with improved quality of life, compared with Paclitaxel in people with advanced or metastatic urothelial cancer, in the setting where the cancer has grown or come back during or within 12 months of completion of platinum based chemotherapy.

Prostate cancer is the most commonly diagnosed cancer in Australian men. If detected early, when disease has not spread, there is a high chance of cure. Relapse, however, is not uncommon despite careful selection of patients prior to surgery or radiotherapy. This, in part, reflects a failure to detect disease spread at baseline due to limited accuracy of current scanning techniques. More accurate scanning may improve outcomes by redirecting patients with disease spread from futile local treatments to more appropriate management.

Urothelial transitional cell cancer (uTCC) is a type of cancer that typically starts in the cells that line the inside of the urinary system. People with “advanced or metastatic urothelial cancer� have cancer which has spread beyond the region of the urinary system, typically to lymph nodes, the wall of the abdomen or pelvis, bones or other organs. Chemotherapy is commonly used in this situation. Chemotherapy drugs of a type called taxanes have commonly been used as a second line treatment. This family of chemotherapy drugs include Nab-Paclitaxel and Paclitaxel. Recruitment to this study ceased on the 7th April 2017 and sites are being closed out. As part of this process, sites are required to submit documents and begin the process of archiving all trial records for 15 years from the end of the trial. And once it becomes available the final trial publication will be submitted to the Human Research Ethics Committee.

e-TC 2.0 A team of cancer survivors, researchers and clinicians developed the e-TC website, which provides evidencebased information and psychological strategies for coping with the challenges associated with testicular cancer. This study aims to evaluate the use and satisfaction with the e-TC website in men who have finished treatment for testicular cancer and are feeling stressed, down or worried about their cancer coming back. Men were recruited through clinicians at participating centres and online via search engine and social media advertising. The study has now closed to recruitment with 40 participants having taken part.

This clinical trial will investigate a new type of scan which provides whole body images of prostate cancer spread. Early experience suggests that this new technology, called PSMA PET/CT (prostate specific membrane antigen positron emission tomography/ computed tomography), is superior to current scanning techniques. PSMA PET/CT has capacity for wide availability at relatively low cost. Performing a single better test rather than several less accurate scans will also be cheaper, improve patient experience and expose patients to lower amounts of radiation. This is a randomised study at multiple centres around Australia comparing PSMA-PET/CT to conventional imaging. If the initial work-up does not demonstrate tumour spread, patients will cross-over to the other imaging arm. We hope to prove that PSMA-PET/ CT has superior diagnostic performance, should be used as a first-line test for staging prior to surgery or radiotherapy and will result in significant changes to patient management. Results of this trial will be used to support funding of this new technology in Australia and internationally. The trial has now closed to recruitment and enrolled 300 participants in Australia.


2018 Fundraising champions Dry August Our thanks to Bernadette Lee with her fundraising campaign “Dry August”. Not only did Bernadette have a very dry August she raised an amazing $3,040 for ANZUP!

Divercity fundraising BBQ As part of fundraising for the Below the Belt Pedalthon, Morton Real Estate, in conjunction with ANZUP, organised the Divercity fundraising BBQ. Residents of the Divercity in Waterloo (Sydney) community joined in for a sausage sizzle (thanks to Colin’s’ Butchery), some refreshments and a business card draw with a fabulous prize from Baby Coffee Co. The community event raised $400.

Karma Keg The Lord Dudley Hotel hosted the ‘Karma Keg’ fundraiser on Father’s Day with the generosity from Yulli’s Brew who donated a keg of beer. Every beer sold had a ‘karma’ price and the patrons choose how much they would spend on their beer (and below the belt cancer research). The Karma Keg promotion raised $1,050. Thank you to The Lord Dudley and Yulli’s Brew for your support

The Lord Roberts Hotel fundraiser On Saturday 18 August, The Lord Roberts Hotel supported ANZUP with a Below the Belt Pedalthon fundraiser. $1 of every drink sold on the day was donated. Our thanks go to Sue Cameron and Darren Davis for this amazing support. The day raised $1,300.

Mike’s Surf Coast Century assault An amazing $3,175 has been raised for ANZUP through Mike’s ultra-running marathon. Read more about Mike’s challenge on page 27.

If you would like to fundraise for ANZUP please contact us at or call 02 9562 5042 THE LORD ROBERTS HOTEL FUNDRAISER and we can assist you with your fundraising page, collateral and information.


ANZUP Pedalthon


$1.4 MILLION 5 years of the Below the Belt Pedalthon


1,500 RIDERS







6,500 DONORS


ANZUP Pedalthon

Below the Belt Research Fund recipients ANZUP exists to improve outcomes for people affected by below the belt cancers. We do this by performing clinical trials to generate the evidence which improves treatments and outcomes for people affected by these diseases. Clinical trials are expensive, difficult and time-consuming and each of ANZUP’s clinical trials requires specific funding. Our goal is to one day be as independent as possible from the uncertainties of grant funding. This would allow us to initiate and even complete trials using our own resources. As a first step to achieving this independence and seeding new projects, the Below the Belt Research Fund was established in 2015. Funding to support this program is raised through the Below the Belt Pedalthon events in Sydney and Melbourne. Since 2016, funds raised for the Below the Belt Research Fund have been fully allocated to 18 projects. All the projects are extremely varied and address the need for new treatments as well as supportive and psychological care for the patient. ANZUP Chair Ian Davis outlines the importance of research and clinical trials:

“Clinical trials are important because this is how we close the loop. If we don’t do clinical trials it is like going a full lap of the circuit and getting just to the finishing line and stopping. All the research in the world means nothing unless we can work out whether it makes a difference.”

In 2018, the Below the Belt Research Fund has provided much needed seed funding to support eight ANZUP members to progress new trial ideas to the point of becoming full scale studies: 1. B en Smith - Development and piloting of a Question Prompt List (QPL) to aid informed treatment decision making in men diagnosed with localised prostate cancer 2. C amille Short - Why do men leave active surveillance? A mixed methods investigation examining factors contributing to adherence on active surveillance 3. C raig Gedye - EnzAdapt: feasibility, acceptability and safety of adaptive dosing of enzalutamide in men with metastatic castrate-resistant prostate cancer 4. E dmond Kwan and Heidi Fettke - Application of a multi-gene prostate circulating tumour DNA (ctDNA) panel in men with metastatic hormone-sensitive prostate cancer (mHSPC) 5. H aryana Dhillon - Assessing the feasibility, acceptability and impact on practice of electronic patient reported outcome assessment of symptoms in people with Genitourinary cancer: a mixed methods study 6. M ark Stein - A pilot trial of Exendin PET scanning in metastatic castrate resistant prostate cancer 7. S homik Sengupta - Feasibility of water irrigation post TURBT for NMIBC 8. S uzanne Chambers - QualTheraP: A nested, multi-perspective longitudinal qualitative study of participants in the TheraP trial


ANZUP Pedalthon

Spotlight on Below the Belt Research Fund studies In this issue of ‘A little below the belt’ we have placed a spotlight on three of the 2018 Below the Belt Research Fund recipients and their studies.

Dr Ben Smith Development and piloting of a Question Prompt List (QPL) to aid informed treatment decision making in men diagnosed with localised prostate cancer Every year more than 16,000 Australian men are diagnosed with prostate cancer. Men diagnosed with localised prostate cancer face a highly preferencesensitive choice between treatments with similar cure rates but different side effects. We recently found that men choosing between robotic prostatectomy and radiotherapy had varied information and decision-making preferences and needs. They often relied on information and recommendations from their clinicians, but such information was often imbalanced or incomplete. This study will develop and evaluate printed and online versions of a Question Prompt List (QPL) to help men get appropriate treatment information from their preferred source (i.e. treating clinicians) while accommodating diverse preferences regarding the type and amount of information desired.

QPLs are a simple and inexpensive communication tool that have been shown to enhance patient participation in decision-making, improve information recall and reduce anxiety in other oncology settings. A multidisciplinary team including consumers, urologists, radiation oncologists, and psychology researchers will develop the QPL. It will be based on QPLs for other cancer groups, our previous research in this area and reviews of the scientific literature and existing resources for men with localised prostate cancer. We will determine: 1) Preference for either the printed or online QPL; 2) Acceptability of the QPL to both patients and clinicians; 3) Feasibility of delivering the QPL early in the decisionmaking process. We expect that the QPL will be a feasible and acceptable tool for improving treatment decision making in men with localised prostate cancer. The study will inform the best timing and method for delivering the QPL.


ANZUP Pedalthon

Dr Camille Short

Associate Professor Craig Gedye

Why do men leave active surveillance? A mixed methods investigation examining factors contributing to adherence on active surveillance

EnzAdapt: feasibility, acceptability and safety of adaptive dosing of enzalutamide in men with metastatic castrate-resistant prostate cancer

Active surveillance is a treatment option for men with low risk prostate cancer that has not spread beyond the prostate. It aims to delay invasive treatments until the disease progresses to a stage that is more appropriate for active treatment (e.g. surgery or radiotherapy). To detect disease progression, the cancer is monitored regularly using a series of tests, such as blood tests and digital rectal examinations.

When prostate cancer spreads, injections that suppress the male hormone testosterone can control the cancer for some time, but it almost always starts to grow again later.

Research suggests approximately 50% of men will transition from active surveillance to active treatment within two years and that up to 38% of these men do so without evidence of disease progression. However these men’s reasons for moving away from active surveillance are poorly understood, and further research is needed to understand why Australian men opt-out of active surveillance for non-clinical reasons. This information will be used to develop supportive care tools and interventions to address these factors and men’s needs. This research will be achieved by firstly surveying men who have transitioned from active surveillance to active treatment, and secondly by interviewing men who left active surveillance for nonclinical reasons.

Hormone tablets to block testosterone on top of the injections can regain control of the cancer, but again, only for a limited time of about one year. Cancers grow like weeds; some of the cancer cells can be controlled but other parts of the cancer aren’t affected and can flourish. These vulnerable and resistant cells of the cancer are often holding each other in balance; and when a treatment is used it can favour one group of cancer cells over another. This trial is designed to test the idea of taking breaks off taking hormone tablets, using them for long enough to control the cancer, but then stopping and saving them up until later to treat the cancer again (and again… and hopefully again and again). While every man’s cancer is predicted to eventually become resistant to hormone treatments, using hormone tablets in a sparing and cunning way is hoped to spread the benefit over a longer period of time, without more side-effects. Very early reports with other drugs support this idea; this will be the first trial testing this idea with enzalutamide (Xtandi). If this idea proves to be sound, it may improve the lives and survival of men with prostate cancer.


What a day! The 5th Sydney Pedalthon rides to success 5 Sydney Pedalthons, 4 cancers, 3,280 laps, 12,812 kilometres and an extraordinary $217,000 raised and funds are still rolling in.

ANZUP All Stars riding for 5 years!

On Tuesday 18 September, over 200 lycra clad, inspirational individuals lined up to ride for 3 hours to raise awareness and vital funds for testicular, prostate, kidney and bladder cancer research. We witnessed grit, determination, cycling prowess as well as a lot of fun on a stunning spring day!

by Karen Bracken

With Pedalthon ambassador and Commonwealth Games Gold Medallist Kaarle McCulloch as the starting motivation the riders took off and rode until they could no more. The event was not all sweat and tears with plenty of coffees, a fleet of masseuses for the tired bodies and a post ride awards lunch with plenty of food and beverages. Over $217,000 was raised this year which brings the total to over $1.4 million raised in 5 years. With the success of the Pedalthon, raising awareness and funds, ANZUP has set up the Below the Belt Research Fund which provides seed funding to ANZUP members (clinicians / researchers) to kick start new trial ideas so they can gather evidence which will hopefully lead to full scale studies. These opportunities would not be available without the Pedalthon. This year’s successful concepts include pathways to assist informed decision making; a pilot of personalised hormone treatment for men with prostate cancer; assessing the potential benefit in reducing recurrence of bladder cancer by irrigation with water after the cancer has been removed; and an app for patients to record their symptoms in real time for review at their clinic visits. The Below the Belt Pedalthon was established to promote awareness of these common below the belt cancers and to provide ANZUP with critical funds required to improve the lives of so many. Every cent raised by the Pedalthon goes directly towards clinical trial research, which means straight into the hands of experts committed to treating testicular, bladder, kidney and prostate cancer.

ANZUP is delighted to confirm the 2nd Melbourne Pedalthon will be held at Sandown, Springvale on Sunday 17 March 2019, and the 6th Sydney Pedalthon will be held at Sydney Motorsport Park, Eastern Creek on Tuesday 10 September. For further information go to or email us at

This year was ANZUP’s fifth Sydney Below the Belt Pedalthon and my fourth. After missing last year due to injury, I was absolutely thrilled to be back riding for ANZUP again this year. Joining me on the ANZUP All Stars team were ANZUP researcher Peter Grimison and my fellow NHMRC Clinical Trials Centre staff Margot Gorzeman, Annie Yeung, Jaclyn Verghis, and Jaclyn’s husband Julius. In keeping with our All Stars team name, we dressed up in silver superhero capes and I loved spotting my team mates, capes flying, as they made their way around the course. Bonus points go to Julius who managed to ride with the peloton despite the extra drag provided by his cape! I was most definitely not in the peloton; instead I happily cruised around for a few hours, before succumbing to the draw of the excellent trackside coffee and plenty of massages. As always, the Below the Belt Pedalthon was a fun and inspiring day. The event showcases the important work that ANZUP do in advancing research and knowledge in below the belt cancers. As a clinical trial manager, I returned to work after the Pedalthon feeling physically and mentally reinvigorated in my endeavour to produce high quality medical research for our trial participants, and for all of us.


Overview of the day Thank you to all the riders who competed in the 2018 Below the Belt Pedalthon in Sydney. Our thanks also go to our wonderful sponsors Morton Real Estate, GenesisCare, Pfizer Oncology, Thirdi Group and Bayer, our very generous event supporters and donors.






Sydney Pedalthon



Balance UTS Breakfast Point Shed Men The Spokey Dokes


Sydney Pedalthon


Fundraising heroes We are thrilled to announce that we have raised more than $217,000 and donations are still rolling in. An extra big thank you to each and every one of our riders, sponsors and donors for your amazing support. Congratulations to Morton Real Estate, the 2018 fundraising champions, who blew fundraising off the track with a huge $10,418 raised. Congratulations also goes to Louise Emmett, the 2018 individual fundraising champion who raised $2,484!

Top fundraisers Individuals


1. Louise Emmett

1. Morton Real Estate

2. Lauren Adler

2. Macquarie Crankers

3. Haryana Dhillon

3. ANZUP Dream Team

4. Peter Lean

4. Breakfast Point Shed Men

5. Jeff Davis

5. Alinta Energy



Sydney Pedalthon

Champions of the track Congratulations to Norton Rose Fulbright who won the 2018 Below the Belt Pedalthon championship title. The team did 156 laps in 3 hours!


Congratulations to the winners • Best Dressed Team: Spin Doctors • Fastest Lap (Female): Krista King





• Fastest Lap (Male): Will Fraser • King of the Mountain: Mitchell Dixon • Queen of the Mountain: Melissa Campbell • Most Laps (Female): Krista King • Most Laps (Male): Will Fraser • Community Team Winner: NSW Ambulance • Diversified Team Winner: Lion - James Squire • Industrial Team Winner: Origin Energy • Professional Services Team Winner: Norton Rose Fulbright • Medical and Pharma Team Winner: GenesisCare • Winner 2 Fastest Laps (Female): Melissa Campbell • Winner 2 Fastest Laps (Male): Will Fraser • Fundraising Team Champions: Morton Real Estate • Fundraising Individual Champion: Louise Emmett • 2018 Below the Belt Pedalthon Champions: Norton Rose Fulbright



Sydney Pedalthon

Gold Sponsor Teamwork. It has long been the foundation of the success of the Morton team and it proved crucial as the team clocked up the laps in our first year participating and as gold sponsor of the amazing ANZUP Below the Belt Pedalthon. On the day our team of 12 riders worked together to maintain their pace, power and enthusiasm as they circled the track. It is important to highlight too, that just as they are in their everyday work, the sales agents were supported on the day of the Pedalthon by an extended team of incredible Morton staff. A team of more than 10 staff worked tirelessly to ensure everything was in place and the riders were hydrated, mentored and motivated to keep pushing on as the temperature rose and the legs inevitably started to freeze and seize. The day itself was incredibly rewarding for everyone involved. Morton’s participation in the Pedalthon was initially inspired by Head of Sales, Jacquie Smith who has volunteered in support of cancer research over a number of years and felt the DARREN DAVIS cause to raise funds for less well known cancers was worthwhile. The focus of ANZUP in raising funds for clinical trials into ‘Below the Belt’ cancers also struck a chord with sales agent Darren Davis having recently lost his mother to kidney cancer.


“When my mother was diagnosed we relied heavily on the wisdom, support and care provided by an amazing group of medical experts, family and friends. For me, participating in the Pedalthon was a reflection of that wonderful teamwork. It shows that working together we can conquer great things,” explained Darren. The Morton sales agents decided to join ANZUP as a 2018 Pedalthon event sponsor. This decision was endorsed by the wider Morton business who matched the agent’s financial contribution and secured Morton the wonderful opportunity to be Gold Sponsors of the event. But that wasn’t enough for the agents who then decided to also enter two teams to ride on the day with an ambitious goal to raise an additional $10,000.00 for the cause. And while the exact number of laps completed by each team member might remain hotly contested there is no dispute fundraising over $10,400.00 was a great achievement and eased the pain of the sore muscles suffered over the days that followed.

Sydney Pedalthon

Gold Sponsor GenesisCare prides itself on being a leader in the health care industry, supporting events that not only raise money for worthwhile causes, but also highlights their commitment to the community. As part of our commitment to designing better care experiences that get the best possible life outcomes for patients, GenesisCare was a gold sponsor of ANZUP’s ‘Below the Belt Pedalthon’ and entered a team in the event. A special mention to John Ketelby, Fergus Rourke, Hugo Rourke, Nic Millett, Elizabeth Marshall and Jason Bonifacio who were part of the GenesisCare team. John Ketelby, Head of Business Development in Australia said he was personally involved in the day because he recognises the importance of ANZUP and the work they do.

“The GenesisCare team hit the track strongly with Liz Marshall, who despite only cycling a couple of times a week put in a massive effort and cycled continuously for 2.5 hours,” John continued. Due to the efforts of the whole team, GenesisCare won the Medical and Healthcare category for completing a total of 132 laps, which equates to about 517km of riding between them.

“I was keen to represent GenesisCare and show our support for the organisation and it also sounded like a great challenge,” John said.

We recognise the great work that ANZUP is doing within the clinical trials and research space to treat ‘below the belt’ cancers which account for more than 27,500 cancers diagnosed in Australia each year.

“The day was fantastic, with perfect weather and an extremely well-organised event.”

GenesisCare is also committed to expanding access to clinical trials and treatment for an innovative therapy called theranostics for advanced prostate cancer patients, so involvement with ANZUP for this worthy event, just made sense.



Sydney Pedalthon

Welcome to new teams Breakfast Point Shed Men

which I did using Huon Pine as a major component. I then asked the Shed President to present it to Peter Lean, the team member who raised the most funds, at our regular Shed meeting. The trophy is now on display in the Shed.

Welcome to the Breakfast Point Shed Men. Thank you to John Bush, Peter Lean, Peter Michell, Ugo Tellini, Vincent Silvestro and Mark Higgins who joined us on the day and collectively rode 94 laps in 3 hours, and are all over 65 years of age! Not only did they ride on the day but were incredible fundraisers, coming in as the 3rd highest fundraising team with $4,509.37 raised and Peter Lean was the 4th highest individual fundraiser.

Tonic Health Media

A: Men’s Sheds have been set up Australia wide, and our Shed brings together older members of the Breakfast Point community for friendship and camaraderie, with the intent of maintaining their health and wellbeing. Members are encouraged to be physically and mentally active through their involvement in activities – social, fundraising, and volunteer projects. Q: How did you find the Below the Belt Pedalthon? A: Fantastic – we all had an amazing time. Q: What was the highlight? A: The event was great. Getting out on the Eastern Creek track was super, and the whole day was so well organised, it was hard not to enjoy ourselves. And we got a free shirt! Q: Any challenges or funny stories? A: Well much to the team leader’s chagrin, most of the other members of the team resorted to e-bikes to complete the event which meant the team leader (me) came last on the number of laps. I had to dob them in! Q: How did you celebrate your success after the Pedalthon? A: After the event I decided to award the team a trophy for their efforts. Being a member of the Shed I had to build it, 62 A LITTLE BELOW THE BELT

We were delighted to welcome the Gallagher’s team to the Pedalthon. Stephen Hughes, Alanna Rados, Gavin Goldsbrough, Jessica Quick, Michael Herron and Robin Johnson took on the challenge with enthusiasm, looking the part in their branded jerseys. Gallagher’s General Manager, Professional Services – Stephen Hughes and team captain for the day gave his update on how he found the event. Q: How did you hear about the Below the Belt Pedalthon?

Leading the charge with organising the team was John Bush who we caught up with after the event. Q: John, tell us about the Breakfast Point Shed Men?


This is the first year Tonic Health Media entered a team in the Pedalthon and what an amazing day it was! A fantastic cause, great camaraderie between the teams, organisers and volunteers and a rare chance to ride bicycles around the Eastern Creek circuit. As a partner of ANZUP, we help inform and educate the public about the importance of clinical trials via our media platforms which are positioned in over 5300 doctors’ waiting rooms, health centres and pharmacies throughout Australia. So we jumped at the opportunity to raise funds and further awareness for this worthwhile cause. One of our riders Jake Thomson, is the Community Relationships Manager for Aboriginal Health TV which Tonic is currently establishing to improve health literacy in Indigenous communities. So in the future, we’ll also be able to communicate the work ANZUP is doing to Aboriginal and Torres Strait Islander communities.

A: I have seen the amazing work ANZUP does and when Marg mentioned the event to me I was keen to be involved and get a team together. Q: Did you enjoy the Below the Belt Pedalthon? A: Really enjoyable day, everyone was in a good mood and friendly and the event was extremely well organised. Q: Are you a regular rider? A: No, I am one of the slow ones! I was pleased that we could go at our own pace and was constantly lapped by the peloton. Q: What was the highlight of the event for you? A: The positive atmosphere and camaraderie and how well the event was organised, it was also a beautiful day to go cycling! Q: How many laps did the Gallagher team do? A: I’m not sure, Alanna was very quick – I think she finished 3rd in the females and Robin was also constantly lapping me in the peloton, as were the others.

A huge thank you to the organisers and everyone who turned up for making it a fun and rewarding day.

Q: What would you say to those considering entering a team in the next Pedalthon?

We are already looking forward to entering a team in next year’s event and challenge other corporates and public organisations to do the same!

A: Go for it! It’s a great day, good for team building, networking and for your Corporate brand to be associated with for such a worthy cause.

Sydney Pedalthon


Sydney Pedalthon

Our superstar Pedalthon ambassador and Commonwealth Games Gold Medallist, Kaarle McCulloch, ensured the Pedalthon was full of excitement, competition and fun. Kaarle talked to the riders and supporters at the post ride lunch about ANZUP, clinical trial research and why the Pedalthon is important to her. She even brought her gold medals. Thank you Kaarle for your amazing support.


Sydney Pedalthon

Jonny Harrison, one of the Pedalthon riders and ambassadors has been hitting the competition circuit in 2018 in his super sleek cycling kit supporting ANZUP and the Pedalthon. Just recently he competed in the national endurance series, the Shimano Grand Prix where he came 2nd overall for the 2018 series. Go Jonny go!


Thanks to Corporate Supporters and In-Kind Supporters Corporate Supporters

In-Kind Supporters

We are very fortunate to have our corporate supporters and partners who enable ANZUP to better support our members and, ultimately, patients and their families. Our 2018 corporate supporters include:

We acknowledge and thank the following organisations for the generosity they have shown by providing their services pro-bono.

Astellas, AstraZeneca, Ipsen, Janssen and Novartis.

Active Display Group, AFI Branding and The Saturday Paper.



Ride or support and help fight prostate, testicular, bladder and kidney cancer. Melbourne Pedalthon Sunday 17 March 2019 Sandown, Springvale, VIC

Sydney Pedalthon Tuesday 10 September 2019 Sydney Motorsport Park, Eastern Creek, NSW

For more information go to


Season’s Greetings from all of us at ANZUP Cancer Trials Group

ANZUP Cancer Trials Group Level 6, Lifehouse Building, 119-143 Missenden Road, Camperdown NSW 2050 Tel: +61 2 9562 5042 Email: