Actively Recruiting
A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer
Led by BioNTech SE · Updated on 2026-05-05
736
Participants Needed
5
Research Sites
N/A
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
Researchers are evaluating whether BNT324 is safe and more effective than the current standard chemotherapy treatment, docetaxel combined with prednisone or prednisolone, for men with metastatic castration-resistant prostate cancer (mCRPC). This trial focuses on participants who have previously been treated with androgen receptor pathway inhibitors but have not received taxane-based chemotherapy for mCRPC. The main goals include measuring how long participants live without their cancer worsening and overall survival. Participants will undergo a screening period lasting up to 28 days, followed by treatment cycles every 21 days. They will be randomly assigned to receive either BNT324 by intravenous infusion or the standard care of docetaxel infusion plus oral prednisone or prednisolone. Treatment continues until the cancer progresses as seen on scans, side effects become unacceptable, the participant decides to stop, or the study concludes. After treatment, there is a 30-day safety follow-up and a long-term survival follow-up, with total involvement lasting up to about 58 months. During the study, participants will have regular assessments including scans reviewed by independent experts, laboratory tests, and monitoring of side effects. Researchers will track outcomes such as radiographic progression-free survival, overall survival, response rates, pain progression, and treatment-emergent adverse events. Safety is overseen by an independent committee to ensure participant well-being throughout the long-term follow-up period.
CONDITIONS
Brief 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
- Documented progressive prostate cancer by PSA progression, radiographic soft tissue progression, or bone disease progression
- Previously treated with one or two androgen receptor pathway inhibitors with disease progression during or after at least 8 weeks of therapy
- No prior taxane-based chemotherapy for metastatic castration-resistant prostate cancer
- Prior orchiectomy and/or ongoing androgen-deprivation therapy with castrate-level serum/plasma testosterone
- Eastern Cooperative Oncology Group performance status of 0 or 1
You will not qualify if you...
- Prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs
- Uncontrolled or significant cardiovascular disease as defined in the protocol
- History or current interstitial lung disease or pneumonitis requiring steroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive treatment with either BNT324 or docetaxel plus prednisone/prednisolone in 21-day cycles. Treatment continues until the cancer worsens, side effects are unacceptable, the participant chooses to stop, or the study ends.
Visits every 21 days for treatment administration
Duration - 30 days
Participants are monitored for safety for 30 days after their last dose of study treatment.
1 follow-up visit approximately 30 days after last treatment
Duration - Up to approximately 58 months
Participants are followed long-term to assess survival outcomes after treatment ends.
Periodic visits during follow-up period
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
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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