Clinical Trial

A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer

Recruiting Phase 3
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Summary
This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC. The main goals of this study are: * To find out if BNT324 helps participants live longer without their cancer getting worse (radiographic progression-free survival \[rPFS\]). * To find out if BNT324 helps participants live longer overall (overall survival \[OS\]).
Protocol Amendment History 4 changes
notable Trial sites expanded: 9 -> 15 locations 2026-07-21
notable Trial sites expanded: 5 -> 9 locations 2026-06-27
critical Recruitment opened 2026-05-06
notable Trial sites expanded: 0 -> 5 locations 2026-05-06
Trial Details
NCT Number NCT07365995
Lead Sponsor BioNTech SE
Collaborators: BioNTech (Shanghai) Pharmaceuticals Co., Ltd., DualityBio Inc.
Conditions Metastatic Castration-resistant Prostate Cancer
Enrollment 736 participants
Start Date 2026-04-22
Primary Completion 2031-02 (estimated)
Study Completion 2031-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-20