AMPLIFY Trial Achieves Participant Enrollment Milestone

Clarity Pharmaceuticals, an emerging clinical-stage radiopharmaceutical company, has successfully met the intended enrollment target for its Phase III AMPLIFY trial. The trial, designed to evaluate 64Cu-SAR-bisPSMA positron emission tomography (PET) in prostate cancer patients exhibiting biochemical recurrence, has seen higher than anticipated participation rates across sites in the United States and Australia.

The AMPLIFY study is a non-randomized, single-arm, open-label, multi-center trial focusing on men with rising or detectable prostate-specific antigen (PSA) after initial definitive treatment. The objective is to assess the diagnostic capabilities of 64Cu-SAR-bisPSMA PET/computed tomography (CT) in detecting prostate cancer recurrence in patients with PSA levels exceeding 0.2 ng/mL. This involves imaging at two timepoints: the first within 1-4 hours after administration (same-day) and the second approximately 24 hours later (next-day).

Launched in May 2025, the trial swiftly reached its recruitment target of around 220 participants within just nine months. The data gathered from AMPLIFY is poised to complement findings from prior Phase I/II COBRA and Phase II Co-PSMA trials, both of which have indicated superior imaging performance of 64Cu-SAR-bisPSMA compared to standard prostate-specific membrane antigen (PSMA) PET imaging in similar patient cohorts.

The results of this pivotal trial are intended to back Clarity’s forthcoming application to the US Food and Drug Administration for the approval of 64Cu-SAR-bisPSMA as a diagnostic imaging agent for patients with biochemical recurrence of prostate cancer. Additionally, 64Cu-SAR-bisPSMA is concurrently under evaluation in the CLARIFY trial, another Phase III study, which aims to assess its performance in detecting prostate cancer within pelvic lymph nodes.

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, remarked on the success of the AMPLIFY trial’s rapid enrollment. This achievement comes despite competing products in the market and reflects the unmet needs within the biochemical recurrence space, alongside the demand from clinicians and patients for a more refined diagnostic alternative.

Clarity Pharmaceuticals continues to advance its SAR-bisPSMA clinical program, seeking to deliver significant benefits in imaging efficacy and contribute to improved management of prostate cancer. The company remains committed to working with regulatory bodies to make this agent available for clinical use.

For more information on the trial and Clarity’s innovative SAR-bisPSMA technology, interested professionals can refer to the ClinicalTrials.gov identifier NCT06970847.