Actively Recruiting
A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Led by BioNTech SE · Updated on 2026-05-05
736
Participants Needed
5
Research Sites
249 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
B
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 \[OS\]).
CONDITIONS
Official Title
A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male adults aged 18 years or older at the time of consent
- Documented progressive prostate cancer confirmed by PSA progression, radiographic soft tissue progression, or new bone lesions
- Prior treatment with one or two androgen receptor pathway inhibitors with disease progression after at least 8 weeks
- No prior systemic taxane-based chemotherapy for metastatic castration-resistant prostate cancer
- Prior orchiectomy and/or ongoing androgen-deprivation therapy with castrate-level testosterone (<50 ng/dL or <1.7 nmol/L); ongoing hormone therapy must continue during the study
- Eastern Cooperative Oncology Group performance score of 0 or 1
You will not qualify if you...
- Prior treatment with B7-H3 targeted therapy, including B7-H3 antibody-drug conjugates
- Uncontrolled or significant cardiovascular disease as defined by the protocol
- History of non-infectious interstitial lung disease or pneumonitis requiring steroids, or current interstitial lung disease or pneumonitis
- Other protocol-defined exclusion criteria
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Trial Site Locations
Total: 5 locations
1
Maryland Oncology Hematology
Rockville, Maryland, United States, 20850
Actively Recruiting
2
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
Texas Oncology South Austin
Austin, Texas, United States, 78731
Actively Recruiting
4
Texas Oncology Gulf Coast
Houston, Texas, United States, 77024
Actively Recruiting
5
Texas Oncology, P.A. - Tyler
Tyler, Texas, United States, 75702
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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