Prostate Cancer Clinical Trials

• Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).

• Must have documented progressive prostate cancer based on at least one of the following criteria:

‣ Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng/mL.

⁃ Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.

⁃ Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria.

• Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy.

• Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC.

• Must have had prior orchiectomy and/or have ongoing androgen-deprivation therapy and a castrate-level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study.

• Must have an Eastern Cooperative Oncology Group performance score of 0 or 1.