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 Interventional Study
PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
370 (estimated)
Sponsor
Jiangsu HengRui Medicine Co., Ltd. · Industry
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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 evalua…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Be willing to participate in this clinical trial, understand the study procedures, and be able to sign the informed consent form in writing; 2. Male, aged ≥ 18 years; 3. ECOG performance status score of 0-1; 4. Expected survival time of no less than 6 months; 5. Prostate aden…
Contacts

Yuezheng Ti

+0518-82342973

yuezheng.ti@hengrui.com

CONTACT