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
2 other identifiers
interventional
736
1 country
5
Brief 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 \[OS\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2026
Longer than P75 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2026
CompletedFirst Posted
Study publicly available on registry
January 26, 2026
CompletedStudy Start
First participant enrolled
April 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2031
May 5, 2026
April 1, 2026
4.8 years
January 23, 2026
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
rPFS assessed by BICR
By arm. rPFS is defined as time from randomization to radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurs first.
From randomization to end of study, i.e., up to 58 months
OS
By arm. OS is defined as time from randomization to death from any cause.
From randomization to end of study, i.e., up to 58 months
Secondary Outcomes (10)
Time to first subsequent therapy (TFTS)
From randomization to end of study, i.e., up to 58 months
Objective response rate (ORR)
From randomization to end of study, i.e., up to 58 months
Duration of response (DOR)
From randomization to end of study, i.e., up to 58 months
Time to pain progression (TTPP)
From randomization to safety follow-up visit (30 days after the last dose), i.e., up to 58 months
rPFS as assessed by investigator
From randomization to end of study, i.e., up to 58 months
- +5 more secondary outcomes
Study Arms (2)
BNT324
EXPERIMENTALDocetaxel plus prednisone/ prednisolone
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).
- Must have documented progressive prostate cancer based on at least one of the following criteria:
- Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng/mL.
- Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.
- Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria.
- Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy.
- Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC.
- Must have had prior orchiectomy and/or have ongoing androgen-deprivation therapy and a castrate-level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study.
- Must have an Eastern Cooperative Oncology Group performance score of 0 or 1.
You may not qualify if:
- Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs.
- Have uncontrolled or significant cardiovascular disease, as defined in the protocol.
- Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or have current ILD/pneumonitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DualityBio Inc.collaborator
- BioNTech SElead
- BioNTech (Shanghai) Pharmaceuticals Co., Ltd.collaborator
Study Sites (5)
Maryland Oncology Hematology
Rockville, Maryland, 20850, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Texas Oncology South Austin
Austin, Texas, 78731, United States
Texas Oncology Gulf Coast
Houston, Texas, 77024, United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, 75702, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
BioNTech Responsible Person
BioNTech SE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2026
First Posted
January 26, 2026
Study Start
April 22, 2026
Primary Completion (Estimated)
February 1, 2031
Study Completion (Estimated)
February 1, 2031
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share