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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 is a Phase 3 study that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 736 participants.
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 \[OS\]).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07365995
The ClinicalTrials.gov registry entry for NCT07365995 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 736 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT07365995 reports 0 study locations.
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.
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