Australia-based clinical-stage radiopharmaceutical company Clarity Pharmaceuticals (ASX:CU6) announced on Thursday that it has imaged the first patient in its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in participants with biochemical recurrence (BCR) of prostate cancer, AMPLIFY, at XCancer in Omaha, Nebraska.

AMPLIFY's official title is '64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants with Biochemical Recurrence of Prostate Cancer'. It is a non-randomised, single-arm, open-label, multi-centre, diagnostic clinical trial of 64Cu-SAR-bisPSMA PET in participants with rising or detectable prostate-specific antigen (PSA) after initial definitive treatment.

The aim of this trial is to investigate the ability of 64Cu-SAR-bisPSMA PET/computed tomography (CT) to detect recurrence of prostate cancer, with evaluation across 2 imaging timepoints, Day 1 (day of administration, same-day imaging) and Day 2 (approximately 24 hours post administration, next-day imaging).

Approximately 220 participants will be enrolled in the study at multiple clinical sites across the United States and Australia. As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the US Food and Drug Administration (FDA) for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in BCR of prostate cancer.