CEO Update

A message from the CEO, Margaret McJannett

ANZUP is a cancer cooperative trials group whose mission is to conduct clinical trial research to improve treatment and outcomes for people affected by bladder, kidney, testicular, penile and prostate cancer. This group of cancers are called urogenital cancers, but we refer to them as below the belt cancers.

Despite the ongoing challenges of outbreaks and snap lockdowns due to COVID-19, ANZUP has remained committed to conducting high quality below the belt cancer trials and research.

The need for improved cancer treatments and outcomes does not stop. And just as we did last year when the pandemic first reared its ugly head, we have continued to be responsive to the health advice and adjust our trials operations and plans in order to maintain productivity, while always ensuring the health and wellbeing of our ANZUP team, members and our trial participants.

We have continued with our virtual Zoom meetings allowing us to host our pipeline of innovative concept development workshops and meetings. We held the second virtual fundraising event, #YourWay, which saw 146 participants around Australia and New Zealand move anywhere, anyway and at any time throughout the month of May. We are very grateful to all our generous donors, raising over $75,000 which will be directed to supporting our pipeline of future clinical trials via the Below the Belt Research Fund https://anzup.org.au/ awards-and-grants/below-the-belt-research-fund/.

Due to the current situation we have been forced to move our face to face annual conference in July to a virtual meeting in October. We also made the difficult decision to postpone our Melbourne Pedalthon cycling fundraising event but are keeping our fingers crossed our Sydney Pedalthon will still go ahead later in the year.

But most importantly, throughout all the ups and downs, we have continued to develop and are soon to open some exciting new research studies which are keeping us extremely busy. The first is a research project, CLIMATE, which focusses on testicular cancer. Micro-ribonucleic acid (miRNA), is a blood test under investigation which evaluates a protein commonly found in testicular cancer. Early studies have found that miRNA is detectable in blood samples of men who have known testicular cancer. The aim of this study is to evaluate the role for miRNA in predicting the risk of cancer recurrence following orchidectomy (surgical removal of one or both testicles) in men who do not have any additional treatment.

If the protein is found following testicular cancer surgery it will indicate if further treatment, or a watch and wait approach, will be necessary.

The second is a trial which also focusses on a blood protein – but this time in prostate cancer. The GUIDE trial aims to show that some men may be able to have breaks in treatment rather than having chemotherapy continuously, which is currently the standard of care.

EVOLUTION is another new prostate cancer trial. This trial is combining radionuclide therapy with immunotherapy and be given to patients who are no longer responding to hormone therapy. The study is supported by the Prostate Cancer Foundation of Australia.

Removing the kidney (or part of a kidney) by surgery is currently the best treatment if you have kidney cancer. Our next new trial, RAMPART will investigate if taking one drug (durvalumab) or a combination of two drugs (durvalumab and tremelimumab) can prevent or delay kidney cancer coming back following surgery.

All our existing trials have continued and some have reached important milestones. The DASL-HiCAP trial, which only opened last year (during COVID-19), is a new cancer trial for treatment of men with high risk, clinically localised prostate cancer. Even with COVID-19 restrictions and challenges worldwide, we are delighted that this ANZUP led international trial has now opened in Australia, New Zealand, Canada and most recently, Ireland, the UK and USA.

Outcomes of the trial will be measured in terms of whether the addition of darolutamide decreases the risk of spread of prostate cancer to other parts of the body as well as improving quality of life and decrease the risk of prostate cancer death.

The American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium is the preeminent genitourinary oncology event held each year. This year at ASCO GU the ANZUP TheraP trial results were presented. TheraP is the first randomised trial comparing a novel radionuclide active treatment, to the current standard-of-care chemotherapy for men with metastatic castration-resistant prostate cancer. These men had disease that had already progressed after standard chemotherapy.

This unique treatment involves first “mapping” the cancer with a PET scan, then treatment with a radioactive substance, Lutetium-177, attached to a similar molecule as used for the PET scan. This novel dual approach of imaging and treatment is called “theranostics.” A favourable response has been demonstrated and this is the first trial in the world comparing a radioactive treatment to an active and effective treatment, and has provided evidence that this might be a good alternative option to chemotherapy for men with advanced and pretreated prostate cancer.

As well as the TheraP trial results being presented at ASCO GU, they were also featured in a high profile medical journal, ‘The Lancet’.

Other ANZUP trial news includes:

• Our BCG+MM study in bladder cancer welcomed the first international site, Nottingham University

Hospital in the UK, onto the trial and the first patient was recruited. This large-scale, randomised trial will determine the effects of adding mitomycin (a chemotherapy agent) to BCG (a bacteria) on cure rates, survival, side effects, and quality of life.

• Cancer Trials Ireland held their first ‘Cancer Retreat’.

This virtual ‘Cancer Retreat’ – was a day-long online event that provided an opportunity to discuss how the cancer trials community works together, how that might be improved, and the challenges and opportunities that may emerge in the coming five years. ANZUP was invited to speak at this inaugural event.

• The ANZUP co-badged study, ProPSMA, won the

Australian Clinical Trials Alliance (ACTA) Trial of The

Year. This was the 2nd year in a row that ANZUP has been recognised for this prestigious award. This clinical trial is investigating a new type of scan which provides whole body images of prostate cancer spread. Early experience suggests 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.

• Our ENZA-p Clinical Trials Protocol featured in the BJUI Journal - congratulations to Professor Louise Emmett and all the ENZA-p team for getting this published.

• We also recently launched our first ever tax appeal.

Every dollar raised from the appeal will go directly towards clinical trial research of ‘below the belt’ cancers. The focus of our tax appeal was prostate cancer and our practice-changing ENZAMET clinical trial.

All current and new trial activity would not be possible without our committed membership. Their ongoing support and dedication to ANZUP, even in light of the current bumps in the road, has allowed us to continue to bridge gaps in knowledge and search for more favourable treatment options, as well as better outcomes, for people affected by below the belt cancer. We also acknowledge the importance of the next generation of scientists and clinical researchers. They will pave the way for clinical trials to come so we continue to seek opportunities to educate and mentor our members.

All the work currently being undertaken and planned would not be possible without the incredible generosity and support of those in the community. Thank you to everyone who has donated to ANZUP - your help allows us to continue to build on and develop high quality, cutting edge, clinical trials. The level of support we receive from our membership and from the wider community, organisations large and small, is nothing short of extraordinary.

If you are interested in receiving regular updates from us, we invite you to join “Friends of ANZUP.” This community will help you stay connected with the work we do. It’s free and you can join by going to https://anzup.org.au/ join-us-friends-of-anzup/.

And finally, I would like to express my gratitude and thanks to the many thousands of patients who participate in ANZUP trials. With your support and cooperation, we can continue to improve treatments and outcomes for the patients and their families affected by below the belt cancers.

On behalf of the ANZUP management team please enjoy this edition of ‘A little below the belt’.

MARGARET MCJANNETT

CEO, ANZUP