A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
Condition: Castration-Resistant Prostatic Cancer
MeSH terms: Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant
Intervention: Niraparib; Abiraterone Acetate; Prednisone; Placebo; New Formulation of Niraparib and Abiraterone Acetate (AA)
Intervention description: Participants will receive niraparib 200 mg capsules once daily.; Participants will receive AA 1000 mg tablets once daily.; Participants will receive prednisone 10 mg tablets daily.; Participants will receive matching placebo once daily.; Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.
Intervention MeSH terms: Prednisone; Abiraterone Acetate; Niraparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 765.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness of niraparib in combination with
      abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HRR gene alteration (as identified by the sponsor's required assays) as follows:

               1. Cohort 1: positive for HRR gene alteration

               2. Cohort 2: not positive for DRD (that is, HRR gene alteration)

               3. Cohort 3: eligible by HRR status

          -  Metastatic disease documented by positive bone scan or metastatic lesions on computed
             tomography (CT) or magnetic resonance imaging (MRI)

          -  Metastatic prostate cancer in the setting of castrate levels of testosterone less than
             or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone
             analog (GnRHa) or bilateral orchiectomy

          -  Able to continue GnRHa during the study if not surgically castrate

          -  Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst
             pain in last 24 hours)

        Exclusion Criteria:

          -  Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP)
             inhibitor

          -  Systemic therapy (that is, novel second-generation AR-targeted therapy such as
             enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4
             months of abiraterone acetate plus prednisone [AAP] prior to randomization) in the
             metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the
             mCRPC setting

          -  Symptomatic brain metastases

          -  History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia
             (AML)

          -  Other prior malignancy (exceptions: adequately treated basal cell or squamous cell
             skin cancer, superficial bladder cancer, or any other cancer in situ currently in
             complete remission) <= 2 years prior to randomization, or malignancy that currently
             requires active systemic therapy