Phase III Study Comparing BNT324 and Docetaxel for Advanced Prostate Cancer
Sponsor: BioNTech SE
ClinicalTrials ID:NCT07365995
This clinical trial is testing a new drug, BNT324, to see if it is safer and more effective than the current standard chemotherapy, docetaxel, for treating advanced prostate cancer that no longer responds to hormone therapy.
Patient Parameters
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Program Overview
The study aims to determine if BNT324 can help patients with advanced prostate cancer live longer without their cancer worsening and improve overall survival compared to the standard chemotherapy treatment with docetaxel and steroids. Participants will be men with advanced prostate cancer that has progressed despite previous hormone therapy but have not yet received chemotherapy for this condition.
Description
The trial includes a screening period of up to 28 days, followed by treatment cycles every 21 days, and a follow-up period after treatment. Treatment will continue until the cancer worsens, side effects become too severe, the participant decides to stop, or the study concludes. Participants will be randomly assigned to receive either BNT324 or the standard treatment of docetaxel with prednisone or prednisolone. An independent committee will regularly review safety and early results to ensure participant safety. The entire study period for each participant is expected to last up to approximately 58 months.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 or older with advanced prostate cancer that is getting worse.
- Cancer progression must be confirmed by rising PSA levels, new or growing tumors on scans, or new bone lesions.
- Must have previously tried one or two hormone therapies and experienced cancer progression during or after at least 8 weeks of treatment.
- Must not have received chemotherapy for advanced prostate cancer.
- Must have had surgery to remove the testicles or be on ongoing hormone therapy to lower testosterone levels.
- Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
Exclusion Criteria
- Have previously received treatment targeting B7-H3, including specific antibody-drug conjugates.
- Have uncontrolled or serious heart disease.
- Have a history of lung disease that required steroid treatment or currently have lung disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Maryland Oncology Hematology | 20850 | Rockville | Maryland |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| Texas Oncology South Austin | 78731 | Austin | Texas |
| Texas Oncology Gulf Coast | 77024 | Houston | Texas |
| Texas Oncology, P.A. - Tyler | 75702 | Tyler | Texas |
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