The ENZAMET Clinical Trial For Prostate Cancer Awarded 2020 ACTA Trial of the Year

San Francisco, CA (UroToday.com) -- The Australian Clinical Trials Alliance (ACTA) has recognised the remarkable Australians who advance the health system through clinical trials at the virtual Clinical Trials 2020: National Tribute and Award Ceremony.

The Awards honour those who design, conduct and participate in ground-breaking clinical trials, and promote the importance of clinical trials and the expertise and complexity of the work involved.

In officially opening the virtual ACTA 2020 Summit and the Awards Ceremony, the Hon Greg Hunt MP, Minister for Health, acknowledged the work of our medical leaders and researchers as genuine national heroes, in a year that has been like no other.

Professor Anne Kelso, CEO of the National Health and Medical Research Council (NHMRC) was the keynote speaker at the event.

Professor John Zalcberg, Board Chair of ACTA, said that whilst causing much hardship and suffering, COVID-19 had nevertheless created opportunities for the sector and put the vital role of trials into the spotlight.

“COVID-19 has raised the profile of our sector and our very talented researchers and clinicians. It has also highlighted the need for rapid approvals and sector adaptability and posed important questions. For example, how can we be responsive to the current crisis, while still ensuring that treatment of many other important conditions continues despite difficult circumstances?” Professor Zalcberg said.
“This year's Award winner demonstrates the innovation and collaboration that the sector is capable of, which is what I know will assist us in pursuing future medical advances.”
One trial scooped the pool at the Awards. The winner of the 2020 ACTA Trial of the Year Award, the ACTA STInG Award for Excellence in Trial Statistics and the Consumer Involvement Award was the ENZAMET Trial. The trial looked at whether adding enzalutamide to hormone therapy right at the beginning of treatment would improve the survival of men with metastatic prostate cancer.

Led by the Australian & New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group, the ENZAMET Trial showed impressive results including a 33% relative reduction in the risk of dying for men who received enzalutamide added to hormone therapy right at the beginning of treatment, compared to men who received the treatment after waiting for the cancer to grow after prior hormone treatment.

The ENZAMET Trial also demonstrated exceptional consumer involvement in the trial design and development through ANZUP’s Consumer Advisory Panel (CAP), which comprises people who have MEDIA RELEASE 2 either had a cancer diagnosis or have cared for a family member or loved one. The CAP played a vital role in the provision of advice and feedback on the trial design and conduct from a community perspective, and ensured that the research was consumer-focused.
Professor Ian Davis accepted the Trial of the Year Award, saying, "I’m honoured to be part of a study that has had such impact for men with metastatic prostate cancer. Professor Christopher Sweeney and I as co-chairs have been part of a talented and dedicated international team of researchers, staff, consumers, and most importantly, our trial participants. I could not be prouder than to have the ENZAMET Trial also acknowledged not only as Trial of the Year, but also for its excellence in trial statistics and consumer involvement.”
2020 ACTA Trial of the Year Winner ACTA STInG Award for Excellence in Trial Statistics Winner ACTA Consumer Involvement Award Winner ENZAMET Enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer: a randomised phase III trial The ENZAMET trial, led by ANZUP Cancer Trials Group, was designed to test whether survival of men with metastatic prostate cancer could be improved even further by adding enzalutamide to hormone therapy right at the beginning of treatment, instead of waiting for the cancer to grow after prior hormone treatment.

ENZAMET showed: a 33% relative reduction in the risk of dying for men who received enzalutamide early like this, even though the other men were able to get that treatment later; delay in time until growth of the prostate cancer; preserved quality of life; more side effects and no additional survival benefit if docetaxel were used as well. The health economic and lab studies, and further clinical follow-up results, are still to come and represent additional value that will be derived from this trial.

About ACTA
Australian Clinical Trial Network (ACTA) is the peak body for the investigator-initiated clinical trials sector, working to consolidate, strengthen and advocate for Australian clinical trials networks, clinical quality registries and clinical trial coordinating centres. ACTA’s vision is for Better health through best evidence. www.clincialtrialsalliance.org.au ACTA gratefully acknowledges operational funding from the Australian Government’s Medical Research Future Fund.

About the Clinical Trials 2020: National Tribute and Award Ceremony
The Awards were established in 2016 and have been traditionally celebrated in International Clinical Trials Day in May, as part of a National Tribute and Awards Ceremony. In 2020, the awards were delayed due to COVID19 and were presented as part of the opening of the Summit. The ACTA Trial of the Year Award finalists were chosen by an independent panel of judges, based on a range of criteria, including trial quality, significance in addressing a critical evidence gap or innovation in healthcare delivery, and the likelihood that trial findings would significantly improve healthcare delivery or outcomes for patients. Those considered for the Consumer Involvement Award were selected based on the significant involvement of consumers in protocol development or design activities to provide valuable and exceptional guidance to the conduct of the trial. The Excellence in Trial Statistics Award was judged by an expert panel convened by the ACTA Statistics in Trials Interest Group (ACTA STInG) group, who considered the statistical aspects of trial design, planning, execution, reporting and interpretation.

Source: Australia Clinica Trial Alliance. (2020 December 2). Clinical Trial for Prostate Cancer Awarded 2020 ACTA Trial of the Year [Press release]. Retrieved from https://clinicaltrialsalliance.org.au/latest-news/media-release-2020-acta-trial-of-the-year/


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