NCT07311694

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	HRS-4357 injection	HRS-4357 injection are administered each time, with dosing for 4 to 6 cycles
DRUG	Enzalutamide；Abiraterone	ARPI (investigator's choice of any of the following agents, with the requirement that the agent has not been used previously): * Enzalutamide 160 mg orally once daily (qd) * Abiraterone 1000 mg orally once daily (qd) + Prednisone 5 mg orally twice daily (bid)

Timeline

• Start date: 2026-02-02
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-12-31
• Last updated: 2026-02-04

Locations

1 site across 1 country: China