Clarity Pharmaceuticals has imaged the first patient in its phase III copper-64 (Cu-64) SAR-bisPSMA diagnostic trial in participants with biochemical recurrence (BCR) of prostate cancer, the Amplify trial, at XCancer in Omaha, NE.
The trial is investigating the use of Cu-64 SAR-bisPSMA PET in participants with rising or detectable prostate-specific antigen (PSA) after initial definitive treatment.
The trial's goal is to investigate the ability of Cu-64 SAR-bisPSMA PET/CT to detect recurrence of prostate cancer, with evaluation across two imaging time points: Day 1 (day of administration, same-day imaging) and Day 2 (about 24 hours post administration, next-day imaging).
The study will enroll around 220 participants at multiple clinical sites across the U.S. and Australia. Clarity said the results intend to provide evidence to support an application to the U.S. Food and Drug Administration (FDA) for approval of Cu-64 SAR-bisPSMA as a new diagnostic imaging agent in BCR of prostate cancer.
