FDA Offers Boost For Prostate Cancer Patients With New 64Cu-SAR-bisPSMA Trial Guidance

Clarity Pharmaceuticals, a clinical-stage company focused on radiopharmaceuticals, is excited to announce the initiation of a pivotal Phase III trial for its 64Cu-SAR-bisPSMA diagnostic. This advancement follows a successful end-of-phase meeting with the U.S. FDA and aims to enhance treatment outcomes for both children and adults battling cancer. The trial, dubbed AMPLIFY (64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants with Biochemical Recurrence of Prostate Cancer), is anticipated to begin recruiting patients in early 2025.

The AMPLIFY trial will be a non-randomized, single-arm, open-label, multi-center Phase III clinical study involving around 220 participants who exhibit rising or detectable PSA levels after initial definitive treatment. As a pivotal trial, the outcomes are designed to generate robust evidence supporting a future FDA application for 64Cu-SAR-bisPSMA as a novel diagnostic imaging agent for prostate cancer.

The primary goal of this Phase III trial is to assess the efficacy of 64Cu-SAR-bisPSMA PET/computed tomography (CT) in identifying the recurrence of prostate cancer. Participants will undergo evaluations at two imaging time points: Day 1, which coincides with the administration of the diagnostic, and Day 2, occurring approximately 24 hours later for follow-up imaging.

Clarity’s Executive Chairperson, Dr Alan Taylor, said in a statement, “We are very excited to progress our second Phase III trial with Clarity’s lead product and appreciate the valuable guidance the FDA has provided in relation to our 64Cu-SAR-bisPSMA program to date. The data we have seen so far for this product has been incredibly favourable and we believe 64Cu-SAR-bisPSMA to be best-in-class. Beyond its clinical benefits, we believe that 64Cu-SAR-bisPSMA’s shelf-life of up to 48 hours will improve patient access to this important diagnostic and broaden the use of radiopharmaceuticals to more clinical sites where the short half-life of current PSMA PET tracers, such as 18F- and 68Ga-based products, restricts their use.”

He further added, “This milestone with the AMPLIFY trial is a testament to the hard work of our team and collaborators. We would like to thank all clinicians and patients who participate in our clinical trials and trust us in delivering on our promise of developing products to improve treatment outcomes. We look forward to commencing recruitment in our registrational AMPLIFY trial early next year and continuing to build on the exceptional data that we have seen in our trials with 64Cu-SAR-bisPSMA to date. We believe that better diagnostic tools will help clinicians determine the best course of treatment for their patients, and our team and collaborators look forward to bringing this next-generation PSMA diagnostic to prostate cancer patients around the world.”