• Phase III AMPLIFY trial has consented in excess of the planned number of participants
• AMPLIFY aims to investigate the diagnostic ability of 64Cu-SAR-bisPSMA PET/CT in detecting prostate cancer recurrence
• Data from AMPLIFY will support FDA approval application for 64Cu-SAR-bisPSMA as a new diagnostic imaging agent

Clarity Pharmaceuticals (ASX: CU6) has announced that the Phase III AMPLIFY trial (NCT06970847) has now consented in excess of the planned number of participants following strong demand for study participation at sites in the United States (US) and Australia. The AMPLIFY trial is a non-randomised, single-arm, open-label, multi-centre, diagnostic clinical trial of 64Cu-SAR-bisPSMA positron emission tomography (PET) in participants with rising or detectable prostate-specific antigen (PSA) after initial definitive treatment. The aim of the study is to investigate the diagnostic ability of 64Cu-SAR-bisPSMA PET/computed tomography (CT) to detect recurrence of prostate cancer in men with PSA levels above 0.2 ng/mL. The data from this study will complement the Phase I/II COBRA and Phase II Co-PSMA trials, which have demonstrated enhanced imaging capabilities of 64Cu-SAR-bisPSMA over standard-of-care PSMA PET imaging in patients with biochemical recurrence of prostate cancer. The final study results from AMPLIFY are intended to provide 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 biochemical recurrence of prostate cancer.

Clarity Pharmaceuticals is also progressing its theranostic Phase I/IIa SECuRE trial and expects to close recruitment in the CLARIFY trial this year. Together with three Fast Track Designations for SAR-bisPSMA and positive interactions with the US FDA to date, these milestones place the company closer than ever to commercialisation of this exciting agent through the entirety of the prostate cancer journey, from first detection to late-stage metastatic disease.