Aussie-led prostate cancer trial combines world-first biomarker with novel drug duo

The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), Ramsay Hospital Research Foundation and Bayer have joined forces on a local clinical trial tackling metastatic castration-resistant prostate cancer (mCRPC).

The Phase 2 trial combines Bayer’s Nubeqa (darolutamide) with Redhill Biopharma’s opaganib – an oral, first-in-class sphingosine kinase-2 (SPHK2) selective inhibitor – with the goal of breaking through the resistance wall that often halts prostate cancer treatment progress.

But what sets this trial apart is its use of the PCPro lipid biomarker test, a world-first innovation developed by Professor Lisa Horvath at Chris O’Brien Lifehouse. The biomarker identifies patients with poorer prognosis who are most likely to respond to the combination therapy.

“The approach of developing therapeutic combinations and the companion lipid biomarker, PCPro, in parallel is unique in metabolic targeting in metastatic prostate cancer, and this exciting study will test the ability of SPHK2 inhibitors, such as opaganib, to overcome resistance to ARPI [androgen receptor pathway inhibitors] treatment,” said Professor Horvath, Chief Clinical Officer and Director of Research at Chris O’Brien Lifehouse.

The trial zeroes in on mCRPC patients who have not been treated with prior androgen receptor inhibitors like Nubeqa, Xtandi (enzalutamide), Erleada (apalutamide), or Zytiga (abiraterone acetate).

PCPro is a plasma biomarker panel that measures levels of three ceramides, total cholesterol, and triglycerides. A positive PCPro status prior to ARPI treatment in mCRPC flags patients with a shorter radiographic progression-free survival (PFS) and overall survival (OS) – a warning signal for likely treatment resistance. For now, data on PCPro or similar lipid biomarkers in metastatic hormone-sensitive prostate cancer remain uncharted territory.

Prostate cancer continues to cast a long shadow in Australia. It’s the most diagnosed cancer in men, with over 26,000 new cases every year and it takes around 10 lives each day, according to the Prostate Cancer Foundation of Australia (PCFA).

Men in regional areas face a 24% higher risk of dying from prostate cancer compared to those in cities. For Aboriginal and Torres Strait Islander men, the disparity is even starker with a 49% higher mortality risk compared to non-Indigenous men.

In the face of these sobering figures, Australia is set to become the first in the world to introduce national clinical guidelines for the early detection of prostate cancer. The draft 2025 guidelines, now closed for public comment, propose a world-first recommendation: offering men a baseline PSA test from age 40, if they’re interested.

General practitioners (GPs) will be urged to take a more proactive stance by initiating conversations and offering PSA testing every two years for men aged 50 to 69. And in a major reversal, the guidelines will support testing men over 70, guided by clinical judgment rather than blanket exclusion.

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