RecruitingPhase 3NCT07311694

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


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

370 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase III trial compares a new drug called HRS-4357 to existing hormone-blocking treatments for advanced prostate cancer that has become resistant to castration (hormone therapy) and has spread to other parts of the body. The cancer must also show a protein called PSMA on its cells. **You may be eligible if...** - You are a male aged 18 or older - You have confirmed metastatic castration-resistant prostate cancer (mCRPC) — prostate cancer that has spread and is no longer responding to hormone therapy - Your cancer tests positive for PSMA (a protein on prostate cancer cells) - Your disease is progressing - Your general health is good (ECOG 0–1) and life expectancy is at least 6 months **You may NOT be eligible if...** - Your cancer does not have PSMA - Your prostate cancer has not yet become castration-resistant - You have major organ problems or other conditions preventing participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS-4357 injection

HRS-4357 injection are administered each time, with dosing for 4 to 6 cycles

DRUGEnzalutamide;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)


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT07311694