Clinical Trial

A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

Recruiting Phase 3
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Summary
This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced metastatic castration-resistant prostate cancer (mCRPC). The efficacy of HRS-4357 versus novel androgen receptor pathway inhibitors (ARPI) in the treatment of PSMA-positive advanced metastatic castration-resistant prostate cancer (mCRPC) will be evaluated based on radiographic progression-free survival (rPFS) assessed by the BIRC.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-30.
Status change: Not Yet Recruiting → Recruiting 2026-02-03
Trial Details
NCT Number NCT07311694
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer
Enrollment 370 participants
Start Date 2026-02-02
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-04