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A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Sponsor: BioNTech SE
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 \[OS\]).
Official title: A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
736
Start Date
2026-04-22
Completion Date
2031-02
Last Updated
2026-10-16
Healthy Volunteers
No
Interventions
BNT324
Intravenous infusion
Docetaxel
Intravenous infusion
Prednisone/prednisolone
Oral
Locations (52)
Sansum Clinic
Santa Barbara, California, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Florida Cancer Specialists- Fort Myers
Fort Myers, Florida, United States
Florida Cancer Specialists- St. Petersburg
St. Petersburg, Florida, United States
Florida Cancer Specialists- West Palm Beach
West Palm Beach, Florida, United States
Piedmont Cancer Institute
Atlanta, Georgia, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Illinois CancerCare PC
Peoria, Illinois, United States
Maryland Oncology Hematology
Rockville, Maryland, United States
NYOH Albany Cancer Center
Albany, New York, United States
White Plains Hospital
White Plains, New York, United States
Oncology/Hematology Care, Inc.
Cincinnati, Ohio, United States
START Carolinas
Myrtle Beach, South Carolina, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology South Austin
Austin, Texas, United States
Texas Oncology Gulf Coast
Houston, Texas, United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, United States
Texas Oncology - West Texas
Wichita Falls, Texas, United States
Virginia Cancer Specialists PC
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Tasman Onco Research Pty Ltd
Southport, Australia
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Peking University First Hospital
Beijing, China
Beijing Cancer Hospital
Beijing, China
The First Affiliated Hospital of Hunan Normal University
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Fujian Medical University Union Hospital
Fuzhou, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Second Hospital of Anhui Medical University
Hefei, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Nanjing Drum Tower Hospital
Nanjing, China
Shanghai Cancer Center
Shanghai, China
No. 10 People's Hospital of Shanghai
Shanghai, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Hubei Cancer Hospital
Wuhan, China
Yijishan Hospital of Wannan Medical College
Wuhu, China
Yantai Yuhuangding Hospital
Yantai, China
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Asklepios Klinik Altona
Hamburg, Germany
Pratia MCM Krakow
Krakow, Poland
National Research Institute of Oncology - National Research Institute (NIO-PIB)
Warsaw, Poland
Addenbrooke's Hospital
Cambridge, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
St James's University Hospital
Leeds, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom