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

The study consists of a screening period (up to 28 days), a treatment period with 21-day cycles, and an after-treatment period that includes a 30-day safety follow-up period and a long-term survival follow-up period. Treatment continues until the cancer clearly gets worse (in scans, based on blinded independent central review \[BICR\] assessment or investigator's decision), side effects become unacceptable, the participant chooses to stop, or the study ends. Participants are put into one of two groups in a 1:1 ratio, which means they will have an equal chance to be in either treatment group, i.e., BNT324 group, or docetaxel plus prednisone/prednisolone group (current SoC). An independent committee will help ensure participant safety, by regularly reviewing safety and early results. For each participant, the treatment and follow-up periods are projected to be up to \~58 months.