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NCT07365995 · ClinicalTrials.gov registry record · Phase 3
A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
A Phase 3 study, sponsored by BioNTech SE.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 736
- Enrollment target
NCT07365995: Recruiting Phase 3 study, sponsored by BioNTech SE.
NCT07365995 is a Phase 3 study that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 736 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07365995, a Phase 3 study, is actively recruiting participants, sponsored by BioNTech SE.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 736 participants
- Enrollment target
Study 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 \[OS\]).
Primary Outcome
By arm. rPFS is defined as time from randomization to radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurs first.
Interventions
- DRUG Docetaxel
- DRUG Prednisone/prednisolone
- DRUG BNT324
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 736 participants |
| Start Date | 2026-04-22 |
| Est. Completion | 2031-02 |
| Phase | Phase 3 |
What NCT07365995 shows while recruiting
NCT07365995 is an interventional study that assigns participants to a tested intervention. The registered 736 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT07365995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07365995 about?
NCT07365995 is a clinical study titled "A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer". 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 partici...
What is the current status of trial NCT07365995?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 736 participants. The study started on 2026-04-22. Estimated completion is 2031-02.
What interventions are being tested in trial NCT07365995?
The interventions under investigation include: Docetaxel (DRUG), Prednisone/prednisolone (DRUG), BNT324 (DRUG).
Who is sponsoring clinical trial NCT07365995?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07365995's enrollment target sits among peer trials
736 479th of 2000 higher than 1,520 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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