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

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03748641
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Castration-Resistant Prostatic Cancer

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    Participants will receive niraparib 200 mg capsules or tablets once daily.
  • Abiraterone Acetate — DRUG
    Participants will receive AA 1000 mg tablets once daily.
  • Prednisone — DRUG
    Participants will receive prednisone 10 mg tablets daily.
  • Placebo — DRUG
    Participants will receive matching placebo once daily.
  • New Formulation of Niraparib and Abiraterone Acetate (AA) — DRUG
    Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.

Study Details

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.

Key Dates

Start date
Jan 25, 2019
Status verified
Jun 2026
Primary completion
Oct 8, 2021
Completion
Feb 27, 2027

Study Design

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

Arms

  • Experimental: Cohort 1: Participants with mCRPC and HRR Gene Alteration
    Participants with L1 metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alteration will receive combination of niraparib 200 milligrams (mg) or matching placebo and abiraterone acetate (AA) 1000 mg plus prednisone 10 mg. In the open label extension (OLE) phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.
  • Experimental: Cohort 2: Participants with mCRPC and No HRR Gene Alteration
    Participants with L1 mCRPC and no HRR Gene alteration will receive combination of niraparib 200 mg or matching placebo and AA 1000 mg plus prednisone 10 mg. In the OLE phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.
  • Experimental: Cohort 3 (Open-label): Participants with mCRPC
    Participants with mCRPC will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets plus prednisone 10 mg.

Primary Outcome Measure

Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to 32 months ]

Locations (47)

FacilityCityStateZIPSite coordinators
Urology Centers Of AlabamaHomewoodAlabama35209-
Mayo Clinic ArizonaPhoenixArizona85054-
Urological Associates of Southern Arizona, P.C.TucsonArizona85741-
Arkansas UrologyLittle RockArkansas72211-
Kaiser PermanenteRiversideCalifornia92505-
San Bernardino Urological AssociatesSan BernardinoCalifornia92404-
University of California San FranciscoSan FranciscoCalifornia94158-
Sansum Clinic PharmSanta BarbaraCalifornia93105-
The Urology Center of ColoradoDenverColorado80211-
Colorado Clinical ResearchLakewoodColorado80228-
VA Connecticut HealthcareWest HavenConnecticut06516-
Bay Pines VA Healthcare SystemBay PinesFlorida33744-
Advanced Urology InstituteDaytona BeachFlorida32114-
Mayo Clinic - Division Of Hematology/oncologyJacksonvilleFlorida32224-
University of Florida Health JacksonvilleJacksonvilleFlorida32209-
Veterans Affairs Medical CtrHinesIllinois60141-
Fort Wayne Medical Oncology and HematologyFort WayneIndiana46825-
First UrologyJeffersonvilleIndiana47130-
University of Kansas Medical CenterKansas CityKansas66160-
Norton HealthcareLouisvilleKentucky40202-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Rcca Md, LlcBethesdaMaryland20817-
Chesapeake Urology Research AssociatesTowsonMaryland21204-
Massachusetts GeneralBostonMassachusetts02114-
Michigan Institute of UrologyTroyMichigan48084-
Kansas City Veterans Affairs Medical CenterKansas CityMissouri64128-
Adult Pediatric Urology & Urogynecology, P.COmahaNebraska68114-
Nebraska Cancer SpecialistsOmahaNebraska68130-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Delaware Valley Urology, LLCMount LaurelNew Jersey08054-
New York Oncology HematologyAlbanyNew York12208-
Icahn School of Medicine at Mount Sinai - The Derald H. RuttenbergNew YorkNew York10029-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Upstate Cancer CenterSyracuseNew York13210-
Helios Clinical Research, LLCMiddleburg HeightsOhio44130-
Oregon Urology InstituteSpringfieldOregon97477-
MidLantic UrologyBala-CynwydPennsylvania19004-
Lancaster UrologyLancasterPennsylvania17604-
VA PittsburghPittsburghPennsylvania15240-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
Urology AssociatesNashvilleTennessee37209-
Houston Metro UrologyHoustonTexas77027-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Utah Cancer SpecialistsSalt Lake CityUtah84106-
Salem VA Medical CenterSalemVirginia80113-
Urology of Virginia, PLCCVirginia BeachVirginia23462-
NorthWest Medical Specialties, PLLCTacomaWashington98405-

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Urology Centers Of Alabama· Homewood, ALMayo Clinic Arizona· Phoenix, AZUrological Associates of Southern Arizona, P.C.· Tucson, AZArkansas Urology· Little Rock, ARKaiser Permanente· Riverside, CASan Bernardino Urological Associates· San Bernardino, CA

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