Clarity Pharmaceuticals Hits Key Milestone in Co-PSMA Trial, Confirms Superior Imaging for Prostate Cancer

Clarity Pharmaceuticals (ASX:CU6), a clinical-stage radiopharmaceutical company developing next-generation cancer diagnostics and therapies, has announced that its Co-PSMA Phase II trial has met its primary endpoint. The investigator-initiated trial demonstrated statistically significant superiority of Clarity’s proprietary 64Cu-SAR-bisPSMA diagnostic over the current standard of care, 68Ga-PSMA-11 PET/CT, for detecting prostate cancer recurrence in patients with low PSA levels.

Led by Prof Louise Emmett at St Vincent’s Hospital in Sydney, the trial showed that 64Cu-SAR-bisPSMA PET/CT detected a greater number of prostate-specific membrane antigen (PSMA)-positive lesions in patients post-radical prostatectomy with biochemical recurrence, a setting where early detection is crucial for guiding salvage therapy.

Executive Chairperson Dr Alan Taylor said the result is a significant validation of Clarity’s proprietary SAR Technology Platform and strengthens the case for 64Cu-SAR-bisPSMA as a potential new standard in PSMA imaging.

“Achieving the primary endpoint in the Co-PSMA trial, in direct comparison to a standard-of-care agent, further validates 64Cu-SAR-bisPSMA as a best-in-class diagnostic. With two Fast Track Designations and Phase III trials underway, we are well positioned to commercialise a superior tool for the early detection of prostate cancer recurrence,” Dr Taylor said.

Raising the Bar in Prostate Cancer Imaging

The Co-PSMA results follow promising data from Clarity’s COBRA and PROPELLER trials, which also demonstrated higher detection rates using 64Cu-SAR-bisPSMA. In COBRA, the agent identified twice as many lesions as SOC imaging in some settings and offered lesion detection up to six months earlier than conventional methods. PROPELLER, meanwhile, confirmed increased tumour uptake and superior image contrast on same-day scans.

Clarity’s 64Cu-based agent offers both diagnostic and therapeutic applications when combined with copper-67—a theranostic pairing that leverages the company’s proprietary SAR chelator technology to prevent free copper leakage and enable same-day and next-day imaging without degradation.

Importantly, 64Cu-SAR-bisPSMA enables detection of very small lesions—down to 2 mm—helping to capture cancer recurrence in its earliest stages. This can be particularly impactful in men with low PSA levels, where standard imaging agents often lack the required sensitivity.

Commercial Implications and Market Opportunity

Clarity estimates the current US market for PSMA PET imaging is around US$2 billion annually, with projections pointing to over US$3 billion by 2029. Yet this market is still dominated by low-sensitivity agents, including 68Ga-PSMA-11, which is unpatented and being commercialised by multiple groups.

With a proprietary, high-sensitivity product and robust clinical data, Clarity believes it is well positioned not only to capture market share but to expand the diagnostic opportunity by enabling earlier intervention.

The company is progressing registrational Phase III trials—AMPLIFY and CLARIFY—in support of FDA New Drug Applications (NDAs), targeting regulatory approvals and commercial rollout in the US and global markets.

As prostate cancer remains the second most diagnosed cancer in men worldwide, and a leading cause of cancer death, the need for earlier and more accurate imaging tools is pressing. Clarity’s latest clinical milestone brings it a step closer to redefining the diagnostic landscape.