• Co-PSMA trial evaluating 64Cu-SAR-bisPSMA vs. 68Ga-PSMA-11 for prostate cancer recurrence detection
• Trial completed enrolment of 50 patients with biochemical recurrence after radical prostatectomy
• Clarity conducting two Phase III trials, CLARIFY and AMPLIFY, to further evaluate 64Cu-SAR-bisPSMA

Clarity Pharmaceuticals (ASX: CU6) has announced the successful completion of recruitment for the Co-PSMA (NCT06907641) Investigator-Initiated Trial led by Prof Louise Emmett at St Vincent's Hospital Sydney. The study is evaluating the performance of Clarity's diagnostic product, 64Cu-SAR-bisPSMA, in comparison to standard-of-care (SOC) 68Ga-PSMA-11 for the detection of prostate cancer recurrence in patients with low prostate-specific antigen (PSA) who are candidates for curative salvage therapy. The Co-PSMA trial enrolled 50 patients in biochemical recurrence (BCR) of prostate cancer, with eligible patients having had radical prostatectomy and a PSA between 0.2 and 0.75 ng/mL. The primary objective is to compare the detection rate of sites of prostate cancer recurrence between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 PET/CT. Clarity has previously demonstrated the diagnostic capabilities of 64Cu-SAR-bisPSMA compared to SOC imaging in the PROPELLER and COBRA trials. Based on these positive results, the company is now conducting two Phase III registrational trials, CLARIFY and AMPLIFY, in the pre-prostatectomy and BCR settings, respectively.

Clarity is excited about the development of 64Cu-SAR-bisPSMA and eagerly anticipates the results from the Co-PSMA trial, which could demonstrate the product's ability to detect more lesions than the current standard-of-care 68Ga-PSMA-11 in patients with low PSA, potentially improving image-guided therapy and outcomes.