A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Phase 3

Active, not recruiting

• Conditions: Metastatic Castration-sensitive Prostate Cancer
• Interventions: Drug: Niraparib; Drug: Abiraterone acetate (AA); Drug: Prednisone; Drug: Placebo for Niraparib

• Registration Number: NCT04497844
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).

Detailed Description

Prostate cancer is a heterogenous disease and recent genomic analyses have highlighted specific germline and somatic mutations and alternative driver growth signaling pathways in patients with metastatic disease. Abiraterone acetate plus prednisone (AAP) is an established standard of care for the treatment of participants with mCSPC and is included in widely accepted clinical treatment guidelines. Niraparib in combination with AAP has been approved for the treatment of BRCA-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC). Niraparib is an investigational agent in the Metastatic Castration-Sensitive Prostate Cancer (mCSPC) population. Whether the addition of niraparib to the AAP standard of care may improve initial disease control and long-term outcomes compared with AAP alone in a biomarker selected mCSPC population is being evaluated on this trial. The study will consist of 4 phases; a Prescreening Phase for biomarker evaluation for eligibility only, a Screening Phase, a Treatment Phase, and a Follow-up Phase. Efficacy evaluations include the following: tumor measurements by computed tomography (CT), magnetic resonance imaging (MRI; abdomen, chest, and pelvis), Technetium-99m (99mTc) bone scans, serum prostate sensitive antigen (PSA) evaluations, and patient reported outcomes (PROs). Safety evaluations include incidence of adverse events and clinical laboratory parameters.

Study Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-04
• Study Start: 2020-09-23
• Primary Completion: 2025-01-07
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-18
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 696

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Niraparib with Abiraterone Acetate plus Prednisone (AAP)	Niraparib	Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily.
Niraparib with Abiraterone Acetate plus Prednisone (AAP)	Prednisone	Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily.
Niraparib with Abiraterone Acetate plus Prednisone (AAP)	Abiraterone acetate (AA)	Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily.
AA plus Prednisone (AAP)	Abiraterone acetate (AA)	Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily.
AA plus Prednisone (AAP)	Prednisone	Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily.
AA plus Prednisone (AAP)	Placebo for Niraparib	Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily.

Primary Outcome Measures

Name	Time	Method
Radiographic Progression-free Survival (rPFS)	Up to 47 months	rPFS is defined as time from randomization date to date of radiographic progression or death, whichever occurs first. Radiographic progression will be evaluated by Prostate Cancer Working Group 3 (PCWG3) criteria and Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Up to 78 months	An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. AE does not necessarily have a causal relationship with intervention.
Overall Survival (OS)	Up to 78 months	OS is defined as the time from date of randomization to date of death from any cause.
Time to Symptomatic Progression	Up to 47 months	Time to symptomatic progression is defined as time from the date of randomization to the date of any of the following (whichever occurs first): a) the use of external beam radiation therapy for skeletal or pelvic symptoms; b) the need for tumor-related orthopedic surgical intervention; c) other cancer-related procedures; d) cancer-related morbid events; e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.
Time to Subsequent Therapy	Up to 47 months	Time to Subsequent Therapy is defined as the time from date of randomization to the date of initiation of subsequent therapy for prostate cancer.

Trial Locations

Locations (385)

Urology Centers Of Alabama; 🇺🇸 Homewood, Alabama, United States

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

Urological Associates of Southern Arizona, P.C.; 🇺🇸 Tucson, Arizona, United States

Greater Los Angeles VA Healthcare System; 🇺🇸 Los Angeles, California, United States

University of California Irvine Medical Center Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

San Bernardino Urological Associates; 🇺🇸 San Bernardino, California, United States

University of San Francisco California; 🇺🇸 San Francisco, California, United States

Rocky Mountain Cancer Centers; 🇺🇸 Colorado Springs, Colorado, United States

AdventHealth Medical Group Urology of Denver; 🇺🇸 Denver, Colorado, United States

Colorado Clinical Research; 🇺🇸 Lakewood, Colorado, United States

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