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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

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 criteria

Qualifiers

Be willing to participate in this clinical trial, understand the study procedures, and be able to sign the informed consent form in writing;

Male, aged ≥ 18 years;

ECOG performance status score of 0-1;

Expected survival time of no less than 6 months;

Disqualifiers

Any radionuclide therapy or hemi-body radiotherapy within 6 months.

Any PSMA-targeted radiopharmaceutical therapy.

Surgery, radiotherapy, or any local therapy within 4 weeks.

Any other investigational drug intervention within 4 weeks.

Trial design

Treatments tested in this trial

  • HRS-4357 injection
  • Enzalutamide;Abiraterone

Treatment groups

370 Participants
are divided into 2 treatment groups