Policy & Regulation
Clarity Pharmaceuticals starts registrational Phase III CLARIFY trial
1 December 2023 -

Clarity Pharmaceuticals (ASX: CU6), an Australia-based, clinical stage radiopharmaceutical company, announced on Thursday that it has started 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 CLARIFY study's aim is to evaluate the diagnostic performance of 64Cu-SAR-bisPSMA to detect regional nodal metastasis in subjects with high-risk prostate cancer prior to radical prostatectomy. The study is expected to enrol 383 subjects at multiple clinical sites across the United States and Australia.

Assessment is to be conducted over two imaging timepoints, day one (day of administration) and day two (around 24 hours post administration). The study is expected to image the first subject 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.