A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)

Inclusion Criteria:

- Histologically confirmed prostate cancer (mixed histology is acceptable, with the
exception of the small cell pure phenotype, which is be excluded

- At least 1 line of prior taxane-based chemotherapy

- At least 1 line of prior androgen receptor (AR) targeted therapy

- Progression of metastatic prostate cancer in the setting of castrate levels of
testosterone or history of bilateral orchiectomy at study entry

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of lesser than or
equal to [<=]1

Exclusion Criteria:

- Known brain metastases or history of seizure

- Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP)
inhibitor

- Prior platinum-based chemotherapy for the treatment of prostate cancer

- Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid
leukemia (AML)

- Severe or unstable cardiovascular disease or uncontrolled hypertension

- Left ventricular ejection fraction (LVEF) of lesser than [<] 50 percent (%) as
determined by multiple uptake gated acquisition (MUGA) or echocardiography during
screening