Clarity Pharmaceuticals (ASX:CU6), an Australia-based clinical-stage radiopharmaceutical company, announced on Thursday that the Co-PSMA Investigator-Initiated Trial (IIT) led by Prof Louise Emmett at St Vincent's Hospital Sydney has now completed study enrolment, with all participants having been imaged.

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.

Co-PSMA (Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy) is a prospective, Phase II imaging trial in 50 patients in biochemical recurrence (BCR) of prostate cancer. Eligible patients were required to have had radical prostatectomy with no salvage therapy and a PSA between 0.2 and 0.75 ng/mL. The primary objective of the trial is to compare the detection rate of sites of prostate cancer recurrence, as determined by number of lesions per patient, between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 PET/CT.

The diagnostic capabilities of 64Cu-SAR-bisPSMA compared to SOC diagnostic imaging have been demonstrated in two prospective clinical trials, PROPELLER and COBRA. Following the positive results of these trials, Clarity is conducting two Phase III registrational trials, CLARIFY and AMPLIFY, in the pre-prostatectomy and BCR settings, respectively.