RecruitingPhase 3NCT07365995

A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer

A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer


Sponsor

BioNTech SE

Enrollment

736 participants

Start Date

Apr 22, 2026

Study Type

INTERVENTIONAL

Conditions

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 \[OS\]).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BNT324, a drug called Docetaxel, and others for people with metastatic castration-resistant prostate cancer. The study is currently recruiting participants at 9 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBNT324

Intravenous infusion

DRUGDocetaxel

Intravenous infusion

DRUGPrednisone/prednisolone

Oral


Locations(33)

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

Illinois Cancer Specialists

Niles, Illinois, United States

Illinois CancerCare PC

Peoria, Illinois, United States

Maryland Oncology Hematology

Rockville, Maryland, United States

White Plains Hospital

White Plains, New York, United States

Oncology/Hematology Care, Inc.

Cincinnati, Ohio, United States

SCRI Oncology Partners

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

The First Affiliated Hospital of Hunan Normal University

Changsha, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Nanjing Drum Tower Hospital

Nanjing, China

Shanghai Cancer Center

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

Addenbrooke's Hospital

Cambridge, United Kingdom

Royal Marsden Hospital

London, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07365995


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