International Clinical Trials Day with Dr Ciara Conduit

International Clinical Trials Day falls on the 20th May each year. It is a day to highlight the importance of clinical trials research and also commemorate the day Scottish physician

DR CIARA CONDUIT James Lind began his study to find a treatment for scurvy in 1747. He did this by dividing 12 sailors into separate groups. He tested the effect of providing different treatments to each group – some were given citrus fruit and some were not. Lind was then 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 clinicians across the world are working together in a global effort to pave the way for a better future through clinical trials. International Clinical Trials Day is about celebrating their work, shining a light on the results, and appealing to those considering medical research as a career.

Dr. Ciara Conduit touches on the importance of International Clinical Trials Day, the work of ANZUP, improving the treatments and outcomes for people affected by below the belt cancers, and an insight into what exciting developments are in the pipeline.

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 develop and support clinical trials and other initiatives for patients with below the belt

cancers.

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 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 because 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 by 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 people 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 people 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 people confronting metastatic castrate resistant prostate cancer.

What sort of areas will clinical trials into below the belt cancers be focusing on in the future?

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 the TheraP trial 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 people 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 cancer. Aim is to improve scans and treatment planning for bladder cancer. 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.

CIARA CONDUIT AT THE 2022 ANZUP ASM