NCT07365995

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

A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 736 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[OS\]).

Detailed description

The study consists of a screening period (up to 28 days), a treatment period with 21-day cycles, and an after-treatment period that includes a 30-day safety follow-up period and a long-term survival follow-up period. Treatment continues until the cancer clearly gets worse (in scans, based on blinded independent central review \[BICR\] assessment or investigator's decision), side effects become unacceptable, the participant chooses to stop, or the study ends. Participants are put into one of two groups in a 1:1 ratio, which means they will have an equal chance to be in either treatment group, i.e., BNT324 group, or docetaxel plus prednisone/prednisolone group (current SoC). An independent committee will help ensure participant safety, by regularly reviewing safety and early results. For each participant, the treatment and follow-up periods are projected to be up to \~58 months.

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	BNT324	Intravenous infusion
DRUG	Docetaxel	Intravenous infusion
DRUG	Prednisone/prednisolone	Oral

Timeline

• Start date: 2026-03-01
• Primary completion: 2031-02-01
• Completion: 2031-02-01
• First posted: 2026-01-26
• Last updated: 2026-01-26

Regulatory

• FDA-regulated drug study