A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Public ClinicalTrials.gov record NCT07365995. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 \[OS\]).
Study identification
- NCT ID
- NCT07365995
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 736 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 21, 2026
- Primary completion
- Jan 31, 2031
- Completion
- Jan 31, 2031
- Last update posted
- Sep 1, 2026
2026 – 2031
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | Recruiting |
| Florida Cancer Specialists- Fort Myers | Fort Myers | Florida | 33901 | Recruiting |
| Florida Cancer Specialists- St. Petersburg | St. Petersburg | Florida | 33701 | Recruiting |
| Florida Cancer Specialists- West Palm Beach | West Palm Beach | Florida | 33401 | Recruiting |
| Illinois Cancer Specialists | Niles | Illinois | 60714 | Recruiting |
| Illinois CancerCare PC | Peoria | Illinois | 61615 | Recruiting |
| Maryland Oncology Hematology | Rockville | Maryland | 20850 | Recruiting |
| White Plains Hospital | White Plains | New York | 10601 | Recruiting |
| Oncology/Hematology Care, Inc. | Cincinnati | Ohio | 45242 | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | Recruiting |
| Texas Oncology South Austin | Austin | Texas | 78731 | Recruiting |
| Texas Oncology Gulf Coast | Houston | Texas | 77024 | Recruiting |
| Texas Oncology, P.A. - Tyler | Tyler | Texas | 75702 | Recruiting |
| Texas Oncology - West Texas | Wichita Falls | Texas | 76310 | Recruiting |
| Virginia Cancer Specialists PC | Fairfax | Virginia | 22031 | Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07365995, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07365995 live on ClinicalTrials.gov.