Clarity Pharmaceuticals Reports Promising Results in SECuRE Trial for Prostate Cancer
The SECuRE trial, a Phase II study conducted by Clarity Pharmaceuticals, has shown promising outcomes in treating metastatic castration-resistant prostate cancer (mCRPC) using the radiopharmaceutical 67Cu-SAR-bisPSMA. A recent trial participant achieved undetectable levels of prostate-specific antigen (PSA) after just one treatment cycle, alongside a negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan following a second cycle.
The participant, a 76-year-old man diagnosed with prostate cancer 15 years ago, had developed metastatic disease by 2020 and entered the trial with progressive mCRPC in 2025. His baseline PSA was 3.25 ng/mL before initiating treatment. Post-treatment, he experienced only mild adverse effects, which included fatigue and resolved symptoms such as altered taste and dry eyes, with no observed hematological or renal side effects.
Clarity Pharmaceuticals has reported similar success in earlier cases, with this being the fifth patient achieving undetectable disease through radiographic assessment following 67Cu-SAR-bisPSMA treatment. Another participant, who previously achieved undetectable PSA following three treatment cycles, maintained these results on recent PSMA PET scans conducted after a fourth cycle.
The Phase II Cohort Expansion Phase involves administering 8 GBq of 67Cu-SAR-bisPSMA per cycle, pending trial expansion. The trial continues to demonstrate a favorable safety profile and promising efficacy levels, meriting its progress towards a registrational Phase III study.
The SECuRE trial's innovative approach involves using 64Cu-SAR-bisPSMA for lesion visualization, aiding in patient selection before administering 67Cu-SAR-bisPSMA therapy. The study is actively enrolling participants in the U.S., aiming for a total of 54 patients.
The trial's advancements follow the favorable outcomes in the earlier Dose Escalation Phase, where significant declines in PSA levels were observed among patients. The ongoing research aims to validate the safety and efficacy of the 67Cu-SAR-bisPSMA therapeutic approach in treating advanced prostate cancer, potentially paving the way for new treatment protocols in oncological healthcare.