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

Plain-language summary

This study compares the drug Niraparib given together with Abiraterone Acetate and Prednisone against Abiraterone Acetate and Prednisone alone in patients with metastatic prostate cancer. Patients with metastatic prostate cancer at castrate testosterone levels, grouped according to their homologous recombination repair (HRR) gene alteration status, can take part. The study is in Phase 3 and is currently not recruiting but is still ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Active, not recruiting

Sponsor

Janssen Research & Development, LLC

Intervention

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

Start date

1/25/2019

Estimated completion

2/27/2027

Countries

United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Related genes

Locations

• Homewood, United States
• Phoenix, United States
• Tucson, United States
• Little Rock, United States
• Riverside, United States
• San Bernardino, United States
• San Francisco, United States
• Santa Barbara, United States
• Denver, United States
• Lakewood, United States
• West Haven, United States
• Bay Pines, United States
• Daytona Beach, United States
• Jacksonville, United States
• Jacksonville, United States
• Hines, United States
• Fort Wayne, United States
• Jeffersonville, United States
• Kansas City, United States
• Louisville, United States
• New Orleans, United States
• Bethesda, United States
• Towson, United States
• Boston, United States
• Troy, United States
• Kansas City, United States
• Omaha, United States
• Omaha, United States
• Las Vegas, United States
• Mount Laurel, United States
• Albany, United States
• New York, United States
• New York, United States
• Syracuse, United States
• Middleburg Heights, United States
• Springfield, United States
• Bala-Cynwyd, United States
• Lancaster, United States
• Pittsburgh, United States
• Myrtle Beach, United States

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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