A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Recruiting now · Phase 3
Conditions studied: Metastatic Castration-resistant Prostate Cancer
In brief
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 \[OS\]).
Key facts
- Study ID
- NCT07365995
- Run by
- BioNTech SE
- People needed
- 736
- Starts
- 2026-04-22
- Expected to finish
- 2031-02-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Rocky Mountain Cancer Centers — Aurora, Colorado, United States (enrolling)
- Florida Cancer Specialists- Fort Myers — Fort Myers, Florida, United States (enrolling)
- Florida Cancer Specialists- St. Petersburg — St. Petersburg, Florida, United States (enrolling)
- Florida Cancer Specialists- West Palm Beach — West Palm Beach, Florida, United States (enrolling)
- Illinois Cancer Specialists — Niles, Illinois, United States (enrolling)
- Illinois CancerCare PC — Peoria, Illinois, United States (enrolling)
- Maryland Oncology Hematology — Rockville, Maryland, United States (enrolling)
- Oncology/Hematology Care, Inc. — Cincinnati, Ohio, United States (enrolling)
- SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
- Texas Oncology South Austin — Austin, Texas, United States (enrolling)
- Texas Oncology Gulf Coast — Houston, Texas, United States (enrolling)
- Texas Oncology, P.A. - Tyler — Tyler, Texas, United States (enrolling)
- Texas Oncology - West Texas — Wichita Falls, Texas, United States (enrolling)
- Virginia Cancer Specialists PC — Fairfax, Virginia, United States (enrolling)
- Virginia Oncology Associates — Norfolk, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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