Clarity Pharmaceuticals announced it has commenced its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY (NCT06056830), with the initiation of the first clinical site 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 metastasis in participants with high-risk prostate cancer prior to radical prostatectomy. The study expects to recruit 383 participants at multiple clinical sites across the United States and Australia.

Evaluation will take place over 2 imaging timepoints, day 1 (day of administration) and day 2 (approximately 24 hours post administration). CLARIFY is expected to image the first participant in late 2023. As a registrational trial, the final study results are intended to provide sufficient evidence to support an application to the US FDA for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer.

SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-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) for therapy.

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA are unregistered products. Individual results may not represent the overall safety and efficacy of the products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA).

A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available. Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide.

The American Cancer Institute estimates in 2023 there will be 288,300 new cases of prostate cancer in the US and around 34,700 deaths from the disease.