BNT324 vs Docetaxel for Metastatic Prostate Cancer

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

Recruiting Phase 3 Interventional Study
Metastatic Castration-resistant Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
736 (estimated)
Sponsor
BioNTech SE · Industry
Who this trial is looking for

This trial is looking for men with advanced prostate cancer that has not responded to certain previous treatments. Participants will compare a new treatment called BNT324 to the standard chemotherapy treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have advanced prostate cancer that is worsening.
  • I have had previous treatment with androgen receptor pathway inhibitors.
  • I have not received chemotherapy for my prostate cancer.
  • I have had surgery to remove my testicles or am on hormone therapy.
  • I have a low level of testosterone.
  • I have a good performance status score.

You may not be able to join if

  • I have received treatment targeting B7-H3.
  • I have uncontrolled heart disease.
  • I have a history of lung issues that required steroids.
  • I have current lung issues.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 wit…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: * 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 progressio…
Contacts

BioNTech clinical trials patient information

+49 6131 9084

patients@biontech.de

CONTACT