Clarity Pharmaceuticals announced that the first patient has been dosed in its pivotal Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY (NCT06056830) at the Urology Cancer Center /XCancer Omaha, NE. The aim of the CLARIFY study is to assess the diagnostic performance of 64Cu-SAR- bisPSMA to detect regional nodal metastases in participants with high-risk prostate cancer prior to radical prostatectomy. The study will recruit 383 participants at multiple clinical sites across the United States and Australia.

Evaluation of the first patient is taking place over 2 imaging timepoints, day 1 (day of administration) and day 2 (approximately 24 hours post administration) and the patient will be followed up as per protocol. Subsequent patients will be evaluated in the same manner. 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 -bisPSMA as a new diagnostic imaging agent in prostate cancer in pre-prostatectomy patients.

CLARIFY derives from "Positron Emission Tomography using 64Cu-SAR- BisPSMA in participants with high-risk PC prior to radical prostatectomy: A prospective, single-arm, multi-centre, blinded-review, Phase III diagnostic performance study". It is a non-randomised, open-label clinical trial in 383 participants. The primary aim of the Phase III trial is to assess the diagnosticperformance of 64Cu-SAR thebisPSMA PET to detect regional nodal metastase.

Furthermore, the safety, tolerability, and consistency of 64Cu-Sar-bisPSMA will be assessed. Evaluation will take place over 2 imaging timepoints. Day 1 (day of administration)and Day 2 (approximately 24 hours post Administration).

SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting twoPSMA-targeting agents to Clarity's proprietary sarcophagene (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a TCT that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu-SAR-bis PSMA are unregistered products.

Individual results may not represent the overall safety and efficacy of the products. A clinical development program is currently underway to assess the efficacy and safety of these products. A clinical development program are currently underway to assess the effectiveness and safety of these products.

The clinical development program is now underway to assess the efficacy and efficacy of these products. A clinical develop program is currently underway to assess The efficacy and safety of these products and safety of these products.