BNT324 versus docetaxel for metastatic castration-resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, phase III trial that assigns participants 1:1 to receive either BNT324 or docetaxel with prednisone/prednisolone in 21‑day treatment cycles. Key eligibility includes men with progressive mCRPC after one or two androgen‑receptor pathway inhibitors and no prior taxane chemotherapy for mCRPC. The co‑primary endpoints are radiographic progression‑free survival (rPFS) and overall survival (OS), with tumor scans reviewed by a blinded independent central review (BICR). Treatment continues until disease progression, unacceptable toxicity, withdrawal, or study end, with safety monitoring by an independent committee and follow‑up planned for up to about 58 months per participant.

Why it matters

Who can join: the full rules

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 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.

Key Exclusion Criteria:

* 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Where it's running

• Sansum Clinic
  Santa Barbara, California, United States Recruiting
• Rocky Mountain Cancer Centers
  Aurora, Colorado, United States Recruiting
• Florida Cancer Specialists- Fort Myers
  Fort Myers, Florida, United States Recruiting
• Florida Cancer Specialists- St. Petersburg
  St. Petersburg, Florida, United States Recruiting
• Florida Cancer Specialists- West Palm Beach
  West Palm Beach, Florida, United States Recruiting
• Piedmont Cancer Institute
  Atlanta, Georgia, United States Recruiting

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BioNTech clinical trials patient information
• Email: patients@biontech.de
• Phone: +49 6131 9084

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.