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

StatusRecruiting
PhasePhase 3
Started2026-02-02
View on ClinicalTrials.gov ↗

Amendment history

2026-02-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-01→confirmed 2026-02-02
Study sitesdetails revised at 1 of 1 site
2025-12-30
Original filing
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.
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