A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer

Metastatic castration-resistant prostate cancer (mCRPC)

Per arm. rPFS is defined as time from randomization to radiographic disease progression per PCWG3-modified RECIST v1.1 criteria, or death from any cause, whichever occurs first., Per arm. OS is defined as time from randomization to death from any cause.

Per arm. TFST is defined as time from randomization to initiation of the first subsequent systemic anticancer therapy or death, whichever occurs first., Per arm. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per PCWG3-modifed RECIST v1.1 as assessed by BICR) is observed as best overall response., Per arm. DOR is defined as time from first objective response (confirmed CR or PR per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) to first occurrence of objective tumor progression (progressive disease per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) or death from any cause, whichever occurs first., Per arm. TTPP is defined as time from randomization to pain progression as determined by Brief Pain Inventory-Short Form Item 3 “worst pain in 24 hours” and opiate analgesic use (Analgesic Quantification Algorithm score)., Per arm. rPFS is defined as time from randomization to radiographic disease progression per PCWG3-modified RECIST v1.1 criteria, or death from any cause, whichever occurs first., By arm. Time to first SSRE is defined as time from randomization to first occurrence of any of the following SSREs: - Use of external beam radiation therapy to prevent or relieve skeletal symptoms. - New symptomatic pathologic bone fracture (vertebral or non-vertebral). - Spinal cord compression. - Tumor-related orthopedic surgical intervention., Per arm. Time to PSA progression is defined as time from randomization to PSA progression per PCWG3 criteria., Per arm. PSA response is defined as having a post-baseline PSA reduction ≥50% from baseline with a consecutive confirmation assessment at least 3 weeks later per PCWG3 criteria., Per arm, from the start of trial treatment until 30 days after the last dose of trial treatment or until start of new systemic anticancer therapy, whichever occurs first: - Occurrence of TEAEs including Grade ≥3, serious, and fatal TEAEs by relationship. - Occurrence of dose interruptions, reductions or discontinuations of trial treatment due to TEAEs.

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