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A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

NCT03748641

Active Not RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Castration-Resistant Prostatic Cancer

Interventions: Niraparib, Abiraterone Acetate, Prednisone, Placebo, New Formulation of Niraparib and Abiraterone Acetate (AA)

Countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (318)

Homewood, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Riverside, California, United States
San Bernardino, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
West Haven, Connecticut, United States
Bay Pines, Florida, United States
Daytona Beach, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Hines, Illinois, United States
Fort Wayne, Indiana, United States
Jeffersonville, Indiana, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Bethesda, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Troy, Michigan, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Mount Laurel, New Jersey, United States
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