SPLASH: Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using 177Lu-PNT2002 PSMA Therapy After Second-line Hormonal Treatment

Metastatic castration-resistant prostate cancer (mCRPC)

Radiological progression-free survival (rPFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Working Group 3 (PCWG3) (bone) criteria.

1. ORR: proportion of patients with partial or complete response (PR or CR, respectively) by BICR based on RECIST 1.1 criteria (soft tissue) and PCWG3 criteria (bone). Duration of response: time from the first date of CR or PR by BICR to the first occurrence of PD by BICR based on PCWG3-modified RECIST 1.1 or death in the absence of progression., 2. Overall survival (OS): time from randomization to date of death from any cause., 3. Time from randomization to first symptomatic skeletal-related event., 4. PSA response rate according to PCWG3 criteria (first occurrence of a 50% or more decline in PSA from baseline, confirmed by a second measurement at least 3 wk later). Biochemical PFS: time from randomization to the date of the first PSA increase from baseline ≥25% and ≥2 ng/mL above nadir confirmed by a 2nd PSA measurement defining progression ≥3 wk later per PCWG3., 5. Safety Endpoints: • Frequency and severity of adverse events and serious adverse events using CTCAE v. 5.0. • Changes from baseline in physical exam findings, vital signs, clinical laboratory values, and electrocardiogram (ECG) values. • Number of patients discontinuing study drug due to adverse events.

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