Clarity Pharmaceuticals dosed its first patient in a pivotal Phase III 64Cu-SAR-bisPSMA diagnostic trial for prostate cancer.
The study, which will include 383 participants in the US and Australia, seeks to reveal if 64Cu-SAR-bisPSMA can reliably detect regional nodal metastases in patients with high-risk prostate cancer before radical prostatectomy.
If the results are positive, Clarity Pharmaceuticals aims to apply to the Food and Drug Administration for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer for pre-prostatectomy patients.