736 Participants NeededMy employer runs this trial

BNT324 vs Docetaxel for Prostate Cancer

Recruiting at 4 trial locations
Bc
Overseen ByBioNTech clinical trials patient information
Age: 18+
Sex: Male
Trial Phase: Phase 3
Sponsor: BioNTech SE
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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 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 \[OS\]).

Who Is on the Research Team?

BR

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Are You a Good Fit for This Trial?

Inclusion Criteria

I am a man aged 18 or older.
My bone scans show new or worsening bone disease.
I've had 1 or 2 treatments targeting the androgen receptor and my cancer still progressed.
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • BNT324
  • Docetaxel
  • Prednisone/prednisolone

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: BNT324Experimental Treatment1 Intervention
Group II: Docetaxel plus prednisone/ prednisoloneActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials
84
Recruited
120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

BioNTech (Shanghai) Pharmaceuticals Co., Ltd.

Industry Sponsor

DualityBio Inc.

Industry Sponsor

Trials
12
Recruited
5,800+

BioNTech Shanghai Pharmaceutical Co., Ltd.

Collaborator