Clarity Pharmaceuticals announced it will be commencing a pivotal Phase III trial of its 64Cu SAR-bisPSMA diagnostic in prostate cancer (PC) following a successful end of phase meeting with the US Food and Drug Administration (FDA). The trial will be named CLARIFY (Positron Emission Tomography using 64Cu SAR-bisPS MA in participants with high-risk PC prior to radical prostatectomy: A prospective, single-arm, multi-centre, blinded-review, Phase III diagnostic performance study) and is expected to begin patient recruitment in late 2023. The FDA is supportive of a prospective, non-randomised, single-arm, open-label, multi-center, Phase III diagnostic clinical trial of 64Cu SAR-bisPSBA PET in 383 participants with untreated, histopathology-confirmed PC, with high-risk features, who are proceeding to radical prostatectomy with pelvic lymph node dissection.

As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the FDA for approval of 64Cu SAR-bis PSMA as a new diagnostic imaging agent in PC. The aim of the Phase III trial is to assess the diagnostic performance of 64Cu SAR-bispsMA PET to detect PC within the pelvic lymph nodes. Evaluation will be across 2 imaging timepoints, Day 1 (day of administration) and Day 2 (approximately 24 hours post administration).

The company would like to thank everyone who contributed to this exciting milestone, from scientific collaborators at the University of Melbourne, who helped overcome the low uptake and washout of first generation PSMA agents by assisting in making an optimised PSMA agent for imaging and therapy, to the patients who participate in clinical trials and to incredible team and collaborators who work tirelessly towards mutual goal of improving treatment outcomes for patients with PC. With this product, in both diagnostic and therapy trials, are now getting very close to achieving this goal.