Cu-SAR-bisPSMA Phase III Trial Targets 220 Patients to Detect Prostate Cancer Recurrence

A New Chapter in Prostate Cancer Diagnostics

Clarity Pharmaceuticals (ASX: CU6) has taken a significant step forward in the fight against prostate cancer with the launch of its second registrational Phase III clinical trial, AMPLIFY. This trial focuses on Cu-SAR-bisPSMA, an innovative positron emission tomography (PET) imaging agent designed to detect biochemical recurrence of prostate cancer. The first clinical site has been activated at XCancer in Omaha, Nebraska, marking the beginning of a multi-centre effort spanning the United States and Australia.

The AMPLIFY trial aims to enroll approximately 220 participants who have experienced a rise or detectable levels of prostate-specific antigen (PSA) following initial treatment. By evaluating imaging at two timepoints, same-day and next-day post-administration, the study seeks to establish the diagnostic accuracy and clinical utility of Cu-SAR-bisPSMA PET/CT scans in identifying recurrent cancer lesions.

Building on Promising Early Data

This Phase III trial builds on encouraging results from earlier studies, including the Phase I/II COBRA and PROPELLER trials. These investigations demonstrated that Cu-SAR-bisPSMA not only has an excellent safety profile but also outperforms current standard imaging agents. Notably, it detects more lesions, including those as small as 2 millimeters, and identifies cancer recurrence earlier, sometimes months before conventional scans.

Such enhanced detection capabilities could be a game-changer for clinicians managing biochemical recurrence, enabling earlier and more precise treatment decisions. The technology’s ability to provide clearer tumour-to-background contrast and higher uptake rates further underscores its potential as a best-in-class diagnostic tool.

Regulatory Momentum and Market Potential

Clarity’s progress has been recognised by the US Food and Drug Administration (FDA), which granted three Fast Track Designations to SAR-bisPSMA within six months. This regulatory support highlights the unmet need for improved prostate cancer diagnostics and therapies, and it accelerates the development pathway for Clarity’s targeted copper theranostic platform.

Executive Chairperson Dr Alan Taylor emphasised the urgency of advancing better diagnostic options, citing the high prevalence of prostate cancer in both the US and Australia. He referenced recent high-profile cases, including former US President Joe Biden and Australian MP Barnaby Joyce, to illustrate the widespread impact of the disease and the critical importance of timely detection.

Looking Ahead

Beyond AMPLIFY, Clarity is conducting several complementary trials, including the CLARIFY study in pre-prostatectomy patients and the Co-PSMA head-to-head comparison study. Additionally, the theranostic SECuRE trial explores Cu-SAR-bisPSMA’s therapeutic potential in metastatic castration-resistant prostate cancer. Together, these efforts aim to establish a comprehensive diagnostic and treatment platform that could reshape prostate cancer management from early detection through to advanced disease stages.

While Cu-SAR-bisPSMA remains unregistered and pending regulatory approval, the clinical and regulatory milestones achieved so far position Clarity Pharmaceuticals as a notable player in the oncology diagnostics space. The coming months will be critical as the AMPLIFY trial progresses and data emerges to validate the promise of this next-generation imaging agent.