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Safety, Efficacy of PSMA-Targeting Agent Being Assessed in mCRPC
Investigators behind the phase 3 SPLASH trial are evaluating the safety and efficacy of 177Lu-PNT2002 (Lu-177-PSMA-I&T) as a PSMA-targeting agent for delaying radiographic progression after second-line hormone treatment in patients with metastatic castration-resistant prostate cancer (mCRPC).
Researchers commenced the study with a 25-patient dosimetry lead-in to determine the efficacy and safety of 177Lu-PNT2002 following treatment with androgen receptor axis-targeted therapy (ARAT) versus abiraterone or enzalutamide with prednisone or dexamethasone.
During the dosimetry phase, approximately 390 patients enrolled will receive up to 4 cycles of 177Lu-PNT2002 at 6.8 GBq every 8 weeks. All patients must meet PSMA PET avidity criteria per blind independent central review (BICR) prior to enrollment with documented progressive mCPRC, chemotherapy-naive characteristics, and are unfit to receive chemotherapy.
In the second phase, all patients will be randomly assigned in a 2:1 ratio to receive 177Lu-PNT2002 in the experimental arm versus the control arm. Patients in the aforementioned arm who experience radiographic progression per BICR may crossover to receive 177Lu-PNT2002.
Radiological progression-free survival (rPFS) will be evaluated as a primary outcome measure as assessed by BICR using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 soft tissue and Prostate Cancer Working Group 3 (PCWG3) bone criteria.
Objective response rate (ORR), duration of response, PSA response, and overall survival (OS) are key secondary endpoints.
“The study is powered at 90% to test the alternative hypothesis of a hazard ratio (HR) ≤ 0.66 at an α of 0.025,” concluded Kim Chi, MD, BC Cancer Agency-Vancouver Centre, Vancouver, BC, Canada, and co-investigators. – Alexa Stoia
