Clarity Doses 383-Participant Target in Phase III CLARIFY

Clarity (ASX:CU6) announced that its registrational Phase III CLARIFY trial has dosed its planned target of 383 participants, a step towards the results it intends to use to support a US FDA application.

CLARIFY is a non-randomised, open-label study of 64Cu-SAR-bisPSMA in participants with untreated, histopathology-confirmed prostate cancer with high-risk features who are proceeding to radical prostatectomy with pelvic lymph node dissection, conducted in the United States and Australia. The primary endpoints are the sensitivity and specificity of 64Cu-SAR-bisPSMA in detecting prostate cancer within the pelvic lymph nodes against histopathology, assessed independently for same-day and next-day imaging. The trial builds on the Phase I PROPELLER study of 30 participants, which the company says showed approximately 30% greater lesion detection and 2-3 times higher tracer uptake and contrast for same-day 64Cu-SAR-bisPSMA PET compared with 68Ga-PSMA-11 PET. Clarity says it now has two registrational Phase III trials of 64Cu-SAR-bisPSMA that have completed recruitment and are in patient follow-up, the other being AMPLIFY in biochemical recurrence of prostate cancer.

Topline data from CLARIFY and AMPLIFY are anticipated in the first half of calendar year 2027. Whether next-day imaging adds benefit in this setting is still to be assessed, and the release does not state when an FDA application would be lodged.