Friday, May 20 is International Clinical Trials Day, a day that highlights the importance of clinical trials research and commemorates the day Scottish physician James Lind began his study to find a treatment for scurvy in 1747.
By dividing 12 sailors into separate groups and testing the effect of providing different treatments to each group, Lind was able to provide evidence of the link between citrus fruit and preventing scurvy. This was the first recorded controlled clinical trial.
Today, thousands of incredible researchers and professors across the world are working together in a global effort to pave the way for a better future through clinical trials. This day is about celebrating their work, shining a light on the results, and appealing to those considering medical research as a career. 
The Australian and New Zealand Urogenital and Prostate Cancer Trials Group – ANZUP – is just one of many groups conducting clinical trials, focusing on research into below the belt cancers (kidney, bladder, testicular, penile, and prostate).
Last year alone, 27,224 Aussies and 4,502 Kiwis were diagnosed with a below the belt cancer, an average of 77 people every day. ANZUP currently has over 7000 patients enrolled across 27 clinical trials being conducted over 650 sites in an effort to significantly reduce this statistic and are running the Below the Belt 77KM in May #YourWay Challenge to help raise awareness and much needed funds in support of this research.
Dr. Ciara Conduit touches on the importance of International Clinical Trials Day, the work of ANZUP in improving the outcomes for people affected by below the belt cancers, and an insight into the future of medical practices.
- Can you please introduce yourself and tell us about your role?
I am a Clinical Research Fellow at the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group helping to develop and support clinical trials and other initiatives for patients with “below the belt” cancers in Australia. By background, I am a specialist Medical Oncologist at Peter MacCallum Cancer Centre, with an interest in genitourinary cancers, particularly testicular cancer, as well as melanoma, new drug development, and communication.
- Can you please tell me about some of the latest research projects that you have been involved in?
In my role at ANZUP, I am fortunate to work with many brilliant Australian clinicians and researchers trying to help answer some of the tough questions that face us in the clinic each day. Recently in this role, my focus has been on the role of immunotherapy in rare variant kidney cancers in ANZUP’s UNISoN clinical trial, as well as personalising chemotherapy for patients with advanced prostate cancer in the GUIDE trial. There are a lot of other exciting studies in the pipeline too!
- From your personal standpoint, can you please tell us what International Clinical Trials Day means for you and what it represents?
To me, International Clinical Trials Day is an opportunity to celebrate those who strive to find answers to the tough clinical questions. Improvements in health outcomes as a result of clinical trials are vital, enabling the development of new interventions, helping to raise standards of treatment, and, crucially, benefiting patients by enabling faster access to the latest treatment. That’s why I do what I do.
- The day also provides our community with a unique opportunity to raise awareness of clinical trials which they know a lot about after COVID!
In recent history, what do you think are some of the major breakthroughs that have come out of Clinical Trials for below the belt cancers?
There have been significant advances in treatment opportunities for patients with below the belt cancers in recent years, led my international collaborations.
In Australia and through ANZUP, we have been involved in many of these important advances including:- ENZAMET / Prostate Cancer- The landmark Australian-led clinical trial, ENZAMET, showed that hormone therapy with a drug called enzalutamide can improve the survival of some men with advanced, hormone-sensitive prostate cancer.
- TheraP / Prostate Cancer – a new treatment for advanced prostate cancer using Lutetium-177 PSMA radionuclide therapy (Lu-PSMA). The primary endpoint of the study was to compare the effects of the two treatments on change in PSA, a blood biomarker of prostate cancer. A favourable response, defined by reduction of PSA by 50% or more, occurred in 66% of men assigned to receive 177Lu-PSMA-617 compared to 37% with cabazitaxel chemotherapy.
- Immunotherapy in kidney cancer – UNISoN tests whether new immune treatments can help people with rare kidney cancer (‘non-clear cell’ cancer).
- Bladder cancer – world first SUBDUE-1 trial, which saw the immune-stimulating cancer drug durvalumab injected directly into patients’ bladder tissue, rather than a vein, for the first time.
- Testicular cancer – Several decades ago testicular cancer was a disease with a very poor prognosis. But now, because of new treatments, tested carefully in clinical trials, it is almost always curable even when it has spread.
- ENZA-p/ Prostate Cancer – Precision medicine is the concept of targeting the right patient for the right treatment at the right time. ENZA-p is a clinical trial that aims to use new theranostic agents to allow more accurate prognostic decision making, and subsequently more effective personalised treatment with less side effects, for men confronting metastatic castrate resistant prostate cancer.
5. What sort of areas will Clinical Trials into below the belt cancers be focusing on in the future? Immunotherapy, genetics, etc.
Oncology is a rapidly changing field, and it is sometimes hard to predict how different things may look in just a short period of time. At ANZUP, we’re excited about the future and focusing on blood-based and imaging biomarkers to help personalise care, as well as novel treatment approaches that might offer patients better cancer control and quality of life, amongst other things. We look forward to seeing how new LuPSMA therapies will transform care in prostate cancer after the results of TheraP and other studies. The following are just some of the current and upcoming trials at ANZUP:
- GUIDE – A randomised non-comparative phase II trial of biomarker-driven intermittent docetaxel versus standard-of-care (SOC) docetaxel in metastatic castration-resistant prostate cancer (mCRPC).
- CLIMATE – Assessing the Clinical utility of miR-371a-3p as a marker of residual disease in Clinical Stage 1 Testicular Germ Cell Tumour, following orchidectomy.
- DIPPER – 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.
- EVOLUTION – Will test the effectiveness of using Lutetium-177-PSMA (Lu-PSMA) and cancer immunotherapy to treat metastatic castration resistant prostate cancer (mCRPC, or advanced prostate cancer).
- ZipUp – First in the world trial investigating a novel type of PET scan in bladder. Aim is to improve scans and treatment planning for bladder cancer.
6. What do survival rates look like at the moment for ‘below the belt’ cancers in Australia and what will they look like in the future?
- Prostate cancer: 95% five-year survival rate after diagnosis, approximately 3,150 deaths in Australia each year. The five-year survival rate for men diagnosed with prostate cancer has increased over the years from 60 per cent to 95 per cent. Nearly all patients who present with localised disease will live beyond five years.
- Compared with other types of cancer, testicular cancer is rare. But testicular cancer is the second most common cancer in young men (aged 18 to 39) excluding non-melanoma skin cancer. However, this form of cancer is highly treatable, even when cancer has spread beyond the testicle. It was estimated only 980 men would be diagnosed with testicular cancer in Australia in 2021. This equates to 1% of all cancers in men. For Australian men, the risk of being diagnosed with testicular cancer by the age of 85 is 1 in 202. The rate of men diagnosed with testicular cancer has grown by more than 50% over the past 30 years, however the reason for this is not known.
- Bladder cancer was the 11th most commonly diagnosed cancer in Australia in 2021.
In 2021, it was estimated 3066 cases of bladder cancer would be diagnosed in Australia (2369 males and 697 females). This is equivalent to an estimated incidence rate of 9.3 cases per 100,000 persons.
Bladder cancer is more common in men than women and in people aged over 60 years. In addition, it was estimated there would be 1020 deaths in Australia from bladder cancer but from 2013 – 2017 on average, 55.3% of people diagnosed with bladder cancer survived 5 years after diagnosis.
Among Australia’s 15 most common malignancies, bladder cancer remains the only one with survival rates that have worsened over the past 30 years.
- Kidney cancer has become increasingly more commonly diagnosed and survival rates continue to improve. This cancer is the 7th most diagnosed cancer in Australia and in 2021 it was estimated there would be 4,377 new cases of kidney cancer diagnosed (2,936 males and 1,441 females). 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.
- Penile cancer is rare. In 2021 there were an estimated 155 cases of penile cancer diagnosed and 28 deaths from this disease. From 2013-2017, on average, 75.4% of males diagnosed with penile cancer survived 5 years after diagnosis. In 2021, the estimated age-standardised incidence rate of penile cancer is 1.1 cases per 100,000 males.
*https://www.aihw.gov.au/reports/cancer/cancer-data-in-australia/contents/summary
7. How does Australia compare vs the rest of the world when it comes to trials and research into below the belt cancer?
ANZUP has been extremely successful in a relatively short space of time with leading global pivotal studies in below the belt cancers. The data from these studies have had a major impact on clinical practice, as best evidenced by a study such as ENZAMET. This study was a key factor in enzalutamide being approved by the Food and Drug Administration (FDA) in America, for metastatic hormone-sensitive prostate cancer. This was a major milestone.
About 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, allied health care professionals, scientists, researchers, and community representatives, all working in areas related to urogenital cancer.
ANZUP has members in every state and territory in Australia and New Zealand, with an increasing international membership.
ANZUP receives infrastructure funding from the Australian Government through Cancer Australia. Fundraising also remains an important part of ANZUP’s activities allowing us to support each and every new clinical trial.
Urogenital cancers, also called below the belt cancers, are those coming from the testicles, prostate, kidney, penis or bladder. ANZUP aims to improve outcomes for people affected by these cancers by exploring and defining priority areas in below the belt cancer research. We investigate which data deserves attention, which treatments hold promise for the future, which drugs should be tested in clinical trials and most importantly, we need to understand the main areas of concern of our patients.
By performing clinical trials we are able to generate new evidence for better treatments, or ways of providing other support.
About Below the Belt 77KM in May #YourWay:
https://www.belowthebelt.org.au/
The Below the Belt 77K in May #YourWay Challenge is about doing it #YourWay from the comfort of your
home, in your office or in your local area to help raise awareness and much needed funds for below the belt cancers.
You can choose to cycle, walk, or run any way. Do it as a team, with your family, with a friend or by yourself. Do it every day, or some days in May.
77k in May #YourWay Challenge is open to all in Australia and New Zealand.
Do 77KM in May #YourWay and help us raise $150,000 for ANZUP’s below the belt cancer research.
