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A Study of BNT324 for Metastatic Castration-Resistant Prostate Cancer

This study is testing a new drug, BNT324, for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and no longer responds to hormone therapy. You may be eligible if you've previously received a specific type of hormone therapy but haven't had taxane-based chemotherapy for mCRPC. Researchers want to see if BNT324 is safer and more effective than the current standard treatment, docetaxel (given with prednisone or prednisolone). The main goals are to find out if BNT324 helps you live longer without your cancer getting worse, and if it helps you live longer overall. The study is currently recruiting about 736 participants.

Study design
This is an interventional study where participants will be randomly assigned to receive either BNT324 or docetaxel plus prednisone/prednisolone. The study aims to enroll 736 participants.
What's involved
You will have a screening period of up to 28 days, followed by a treatment period with 21-day cycles. Treatment continues until your cancer worsens, side effects are too severe, you choose to stop, or the study ends.
Compensation
Not stated in the trial record.
Follow-up
After treatment, there will be a 30-day safety follow-up and a long-term survival follow-up, projected to be up to 58 months in total.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07365995

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
BioNTech SE
~736 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:BNT324DocetaxelPrednisone/prednisolone

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
rPFS assessed by BICR
Measured over From randomization to end of study, i.e., up to 58 months
+1 more outcome measured

Conditions

Metastatic Castration-resistant Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

15 sites across 8 states
Texas4
Florida3
Illinois2
Virginia2
Colorado1
Maryland1
Ohio1
Tennessee1

Study leadership

  • BioNTech Responsible Person · STUDY_DIRECTOR · BioNTech SE

Who to contact

BioNTech clinical trials patient information
[email protected]
+49 6131 9084 · ext. 0
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • rPFS assessed by BICRFrom randomization to end of study, i.e., up to 58 months

    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.

  • OSFrom randomization to end of study, i.e., up to 58 months

    By arm. OS is defined as time from randomization to death from any cause.