Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations

Prior treatment

• Any previous treatment with a poly (adenosine diphosphate \[ADP\] ribose) polymerase (PARP) inhibitor, including olaparib.
• Subjects who had any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose \> 5 years prior to randomization.
• History of another primary malignancy except for malignancy treated with curative intent with no known active disease for ≥5 years before the first dose of study intervention and of low potential risk for recurrence.
• Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.

• Histologically confirmed diagnosis of prostate cancer.
• Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
• Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .
• Ongoing therapy with LHRH analog or bilateral orchiectomy.
• Radiological progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
• Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue.
• Normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.