Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

Inclusion Criteria

• 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.
• Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
• Qualifying HRR mutation in tumor tissue.

Exclusion Criteria

• Any previous treatment with PARP inhibitor, including olaparib.
• Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose > 5 years prior to randomization.
• Other malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥5 years.
• Subjects with known brain metastases.