Phase III Study Comparing BNT324 With Docetaxel Plus PrednisonePrednisolone for Men With Metastatic Castration-resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating BNT324, a new drug, compared to the current standard chemotherapy treatment docetaxel with prednisone or prednisolone in men with metastatic castration-resistant prostate cancer mCRPC. This study focuses on participants who have previously been treated with androgen receptor pathway inhibitors but have not received taxane-based chemotherapy for mCRPC. The main goals are to see if BNT324 can help participants live longer without their cancer worsening and improve overall survival. Participants are randomly assigned to one of two groups one group receives BNT324 through intravenous infusion, and the other group receives docetaxel infusions combined with oral prednisone or prednisolone. The study includes a screening period lasting up to 28 days, followed by treatment cycles every 21 days. Treatment continues until the cancer clearly worsens, side effects become unacceptable, the participant chooses to stop, or the study ends. After treatment, there is a 30-day safety follow-up and a long-term survival observation that may last up to about 58 months. During the study, participants undergo regular assessments including scans reviewed by an independent committee, laboratory tests, and evaluations of symptoms and side effects. Researchers will monitor how long participants live without cancer progression and overall survival, as well as other measures like response to treatment and time to symptom worsening. Safety is closely tracked throughout treatment and follow-up. The total time a participant may be involved in the study, including follow-up, is up to approximately 58 months.

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