LATEST NEWS: 24 September 2025

TROG is set to open the Australian arm of an international trial that aims to change practice in the treatment of high-risk prostate cancer, after the research team was awarded a $1.9 million Medical Research Future Fund (MRFF) Clinical Trials Activity grant.

Marking a new era of international collaboration, TROG is partnering with the US-based clinical trial organisation NRG Oncology Group on the NRG-GU013 HIGH-FIVE trial. Prof Wee Loon Ong from Monash University is leading the Australian arm of the trial, funded by the 2024 MRFF International Clinical Trial Collaborations Round 2 grant.

Prostate cancer is the most commonly diagnosed cancer in Australia each year, with an average of 55 men diagnosed every day (20,000 per year).

Currently, external beam radiation therapy (EBRT) for curing prostate cancer involves 20-45 daily visits over a period of 4-9 weeks. However, novel, sophisticated technology called stereotactic body radiation therapy (SBRT) is allowing treatment to be shortened to just five visits.

The phase III randomised HIGH-FIVE trial is comparing 20-45 daily treatments with EBRT (the control arm) with five treatments with SBRT (the intervention arm). The trial’s primary endpoint is metastases-free survival.

If the study finds the five-treatment prostate SBRT is as effective as traditional ERBT in terms of cancer control, it could change practice globally, heralding a new standard-of-care radiation therapy option for high-risk prostate cancer.

This would have huge implications both for patients’ treatment experience, and for public healthcare cost savings.

TROG is the Australian sponsor of the trial, following acceptance as a main member of NRG Oncology group last year. Recruitment for the HIGH-FIVE started in the USA in December 2023, with 345/1209 participants enrolled to date. The trial is currently running in USA, Canada, Switzerland and Singapore with 69 sites active on the study.

Extending the trial to Australian sites is set to accelerate the translation of findings. An estimated 210 participants will be recruited from 10 sites across Australia, including regional centres.

Prof Ong (pictured left) said the collaboration between TROG investigators and world-leading researchers in NRG Oncology on the trial would increase Australian clinical trial capacity and capability.

The HIGH-FIVE study could have far-reaching impacts on management of high-risk prostate cancer in Australia and globally, he said.

“The HIGH FIVE trial will provide the highest quality evidence to date on the comparative clinical effectiveness, safety and cost effectives of 5-fraction SBRT, compared to the current standard of care EBRT approach for treating high-risk and/or node-positive prostate cancer,” he said.