Clarity Pharmaceuticals (ASX: CU6), a clinical-stage radiopharmaceutical company focused on developing next-generation products to improve cancer treatment outcomes, has announced the successful completion of patient recruitment for the Co-PSMA Investigator-Initiated Trial (IIT) at St Vincent’s Hospital Sydney. Led by Professor Louise Emmett, the trial has now imaged all participants. The Co-PSMA trial (NCT06907641) is designed to evaluate Clarity’s diagnostic product, Cu-SAR-bisPSMA, against the standard-of-care Ga-PSMA-11 for detecting prostate cancer recurrence in patients with low prostate-specific antigen (PSA) levels who are candidates for curative salvage therapy.
The Phase II trial enrolled 50 patients with biochemical recurrence (BCR) of prostate cancer following radical prostatectomy and no salvage therapy, with PSA levels between 0.2 and 0.75 ng/mL. The primary objective is to compare the detection rate of prostate cancer recurrence sites, measured by the number of lesions per patient, between Cu-SAR-bisPSMA and Ga-PSMA-11 PET/CT scans. Previous trials, PROPELLER and COBRA, have demonstrated the diagnostic capabilities of Cu-SAR-bisPSMA compared to standard diagnostic imaging.
Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, expressed excitement about the milestone and the development program of Cu-SAR-bisPSMA. He highlighted the high unmet need for more effective diagnostic tools for men with rising PSA after radical prostatectomy. Visualising cancer early is crucial for determining the optimal treatment course and improving patient outcomes. Professor Emmett noted that current PSMA PET products have limitations in sensitivity, particularly in patients with low PSA, and that the Co-PSMA trial aims to address this unmet need.
Clarity is also conducting two Phase III registrational trials, CLARIFY and AMPLIFY, in the pre-prostatectomy and BCR settings, respectively. St Vincent’s Hospital Sydney is actively recruiting for the CLARIFY trial and will soon begin recruiting for the AMPLIFY trial, with Professor Emmett as the principal investigator. The company anticipates reporting the results of the Co-PSMA trial in the coming months.
