Below the Belt Move #YourWay
Below the Belt Research Fund Every cent we raise through the Below the Belt events goes directly towards clinical trial research via the Below the Belt Research Fund. In 2020, ANZUP’s Below the Belt Research Fund provided much needed seed funding to support five ANZUP members to progress new trial ideas to the point of becoming full scale studies.
LOUISE EMMETT
Professor Louise Emmett and Professor Michael Hofman – PRIMARY 2: A prospective, multicentre, randomised study of Ga-68PSMA /CT + mpMRI vs mpMRI alone for prostate cancer diagnosis
MATTHEW ROBERTS
Dr Matthew Roberts – De-Intensification of Post ProstatEctomy Radiotherapy (DIPPER) incorporating clinical and imaging - based risk stratification: Part 1 Pilot study (additional site)
62 A LITTLE BELOW THE BELT
MRI is now routinely utilised for the diagnosis of prostate cancer in Australia. However, it still misses about 15-20% of important cancers, and about half of the biopsies undertaken after MRI are negative, because MRI is not completely accurate. PSMA PET is a new technique that is helpful in staging men who have already been diagnosed with prostate cancer. The PRIMARY trial - currently underway is assessing the value of PSMA PET in men who are suspected of having prostate cancer, and are undergoing both an MRI and a prostate biopsy. This trial proposes to randomise men between MRI + biopsy (if required) - the current standard of care in Australia, and MRI /PSMA + biopsy (if required). The study hypothesis is that PSMA MRI will
This clinical trial will use modern PET scanning (PSMA PET/CT) in men who have a rising PSA level after prostate surgery to select those who can potentially avoid or minimise additional (radiation, hormone) treatments safely. Previous studies reported that these men who have a negative or confined PSMA PET have good treatment responses to limited radiation treatment without hormones compared to men whose cancer has spread. Some men with a negative PSMA PET who were not treated did not progress over 3 years, suggesting that some men can be spared treatment altogether. The purpose of this trial is to determine if some men with low risk cancer who can be safely monitored,
both reduce unnecessary biopsies and improve accuracy of prostate cancer diagnosis, compared to using MRI alone. Also, a health economics analysis to assess cost to the community and QOL for men with prostate cancer is an important component of this trial. To date, the study has enrolled 230/309 men, and the results are looking promising for combination of PSMA and MRI to be more accurate than MRI alone in diagnosing important prostate cancers. There is the potential for imaging to play a much bigger role in diagnosis of prostate cancer and for the number of biopsies required to be safely reduced.
then avoid treatment side effects without compromising disease control. This trial will be limited to men who are deemed as “Low Risk” for spreading cancer using criteria from the European prostate cancer guidelines. If the PSMA PET result is negative, the trial will randomly choose close surveillance and delayed treatment or standard radiation treatment. If the PSMA PET result is positive and confined, men will receive standard radiation treatment to the prostate and the other half will receive additional hormone treatment. If positive and spread outside the prostate area, selected treatments and responses will be monitored for some years.
