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-MutatedProstatic Neoplasms (mCSPC)

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04497844
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib+ Abiraterone acetate fixed dose combination (FDC) — COMBINATION_PRODUCT
    Participants will receive a FDC of Niraparib 200 mg + AA 1000 mg once daily.
  • Abiraterone acetate (AA) — DRUG
    Participants will receive AA 1000 mg once daily.
  • Prednisone — DRUG
    Participants will receive prednisone 5 mg once daily.
  • Placebo FDC — DRUG
    Participants will receive matching placebo for Niraparib +AA FDC once daily.
  • Placebo AA — DRUG
    Participants will receive matching placebo for AA once daily.

Study Details

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).

Key Dates

First listed
Aug 4, 2020
Start date
Sep 23, 2020
Status verified
Aug 2026
Primary completion
Jan 7, 2025
Completion
Nov 1, 2027

Study Design

Enrollment
696 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib with Abiraterone Acetate plus Prednisone (AAP)
    Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg) + abiraterone acetate (AA) 1000 mg fixed dose combination (FDC) along with placebo for AA and prednisone 5 mg once daily.
  • Active Comparator: Placebo for Niraparib + AA FDC plus AA and prednisone (AAP)
    Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib+AA FDC along with AA 1000 mg and prednisone 5 mg once daily.

Primary Outcome Measure

Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator [ Time Frame: From date of randomization (Day -3 to Day 1) up to approximately 49 months ]

Locations (53)

FacilityCityStateZIPSite coordinators
Urology Centers Of AlabamaHomewoodAlabama35209-
Mayo Clinic ArizonaPhoenixArizona85054-
Urological Associates of Southern Arizona, P.C.TucsonArizona85741-
Greater Los Angeles VA Healthcare SystemLos AngelesCalifornia90073-
University of California Irvine Medical Center Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
San Bernardino Urological AssociatesSan BernardinoCalifornia92404-
University of San Francisco CaliforniaSan FranciscoCalifornia94158-
Rocky Mountain Cancer CentersColorado SpringsColorado80907-
AdventHealth Medical Group Urology of DenverDenverColorado80210-
Colorado Clinical ResearchLakewoodColorado80228-
Eastern Connecticut Hematology & Oncology Assoc.NorwichConnecticut06360-
Advanced Urology InstituteDaytona BeachFlorida32114-
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer CenterFort LauderdaleFlorida33308-
Cancer Specialists of North FloridaJacksonvilleFlorida32256-
University of Florida Health JacksonvilleJacksonvilleFlorida32209-
Urology of IndianaGreenwoodIndiana46143-
First UrologyJeffersonvilleIndiana47130-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Baltimore VA Medical CenterBaltimoreMaryland21201-
Maryland Oncology Hematology, PAColumbiaMaryland21044-
Chesapeake Urology AssociatesTowsonMaryland21204-
Michigan Institute of UrologyTroyMichigan48084-
Mosaic Life CareSaint JosephMissouri64507-
St. Louis VA Medical CenterSt LouisMissouri63109-
GU Research NetworkOmahaNebraska68130-
New York Oncology HematologyAlbanyNew York12206-
Manhattan VAMCNew YorkNew York10010-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Mount SinaiNew YorkNew York10029-
Associated Medical ProfessionalsSyracuseNew York13210-
Montefiore Medical CenterThe BronxNew York10461-
Durham VAMCDurhamNorth Carolina27705-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
VA Portland Health Care SystemPortlandOregon97239-
Oregon Oncology SpecialistsSalemOregon97301-
Keystone Urology SpecialistsLancasterPennsylvania17604-
Philadelphia VA Medical CenterPhiladelphiaPennsylvania19104-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical Center (UPMC)PittsburghPennsylvania15232-
Ralph H. Johnson Veterans Affairs Medical CenterCharlestonSouth Carolina29401-
Prisma HealthSenecaSouth Carolina29672-
Urology AssociatesNashvilleTennessee37209-
Texas Oncology-AustinAustinTexas78731-
Texas Oncology - NortheastDentonTexas76201-
Houston Metro UrologyHoustonTexas77027-
Texas Oncology P ANew BraunfelsTexas78130-
Texas Oncology - Northeast 1TylerTexas75702-
University of Utah Huntsman Cancer InstituteSalt Lake CityUtah84112-
Virginia Oncology AssociatesNorfolkVirginia23502-
Virginia Commonwealth University - Massey Cancer CenterRichmondVirginia23298-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
VA Puget Sound Healthcare SystemSeattleWashington98108-
MultiCare Health SystemTacomaWashington98405-

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Urology Centers Of Alabama· Homewood, ALMayo Clinic Arizona· Phoenix, AZUrological Associates of Southern Arizona, P.C.· Tucson, AZGreater Los Angeles VA Healthcare System· Los Angeles, CAUniversity of California Irvine Medical Center Chao Family Comprehensive Cancer Center· Orange, CASan Bernardino Urological Associates· San Bernardino, CA

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