How Clarity’s Cu-SAR-bisPSMA Is Changing Prostate Cancer Detection Ahead of EAU 2026

Clarity’s Breakthrough in Prostate Cancer Imaging

Clarity Pharmaceuticals (ASX – CU6) has announced a significant milestone with the acceptance of its Co-PSMA Phase II trial abstract for oral presentation at the European Association of Urology (EAU) Congress 2026. This trial, led by Professor Louise Emmett at St Vincent’s Hospital Sydney, evaluated Clarity’s Cu-SAR-bisPSMA diagnostic agent against the current standard-of-care Ga-PSMA-11 PET/CT imaging in detecting prostate cancer recurrence.

The Co-PSMA study focused on a challenging patient group – those with low prostate-specific antigen (PSA) levels between 0.2 and 0.75 ng/mL following radical prostatectomy, who had not yet undergone salvage therapy. In this setting, early and accurate detection of recurrent lesions is critical for guiding curative treatment decisions.

Superior Detection Performance Confirmed

Results from the trial demonstrated that Cu-SAR-bisPSMA detected significantly more lesions per patient than the standard Ga-PSMA-11 PET/CT. This finding builds on earlier data suggesting that Clarity’s agent can identify smaller and more lesions, and do so earlier than existing imaging agents, which have known limitations in sensitivity at low PSA levels.

Cu-SAR-bisPSMA leverages Clarity’s proprietary sarcophagine (SAR) technology, which securely binds copper isotopes within a cage-like chelator, preventing copper leakage and enhancing imaging quality. This innovative approach differentiates it from competitors and supports its dual diagnostic and therapeutic potential using copper-64 for imaging and copper-67 for therapy.

Strategic Positioning in a Growing Market

Executive Chairperson Dr Alan Taylor highlighted the rapid progress of Cu-SAR-bisPSMA from invention to multiple clinical trials, including two registrational Phase III studies expected to complete recruitment next year. With two FDA Fast Track designations, Clarity is positioning itself strongly within the expanding PSMA PET imaging market, currently valued at around USD 2 billion and projected to exceed USD 3 billion by 2029.

The acceptance of the Co-PSMA data for oral presentation at the EAU Congress, Europe’s largest urological conference, underscores the clinical relevance and scientific rigor behind Clarity’s development program. Professor Emmett’s involvement, a recognized global expert in urologic nuclear medicine, further validates the trial’s significance and the potential impact on prostate cancer management.

Looking Ahead

While Cu-SAR-bisPSMA remains an unregistered product pending regulatory approvals, the mounting clinical evidence and ongoing trials suggest it could soon offer a meaningful improvement over current diagnostic standards. The full Co-PSMA results, to be presented in March 2026, will be closely watched by clinicians and investors alike as they could influence future treatment paradigms for prostate cancer patients worldwide.