A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
pharmaand GmbH
Study ID
NCT02975934
Phase
PHASE3
Status
Completed

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

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

Interventions

  • Rucaparib — DRUG
    Rucaparib will be administered daily.
  • Abiraterone acetate or Enzalutamide or Docetaxel — DRUG
    Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.

Study Details

The purpose of this study is to determine how participants with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

Key Dates

Start date
Jun 13, 2017
Status verified
Jul 2025
Primary completion
Aug 25, 2022
Completion
Aug 8, 2024

Study Design

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

Arms

  • Experimental: Rucaparib
    Oral rucaparib (monotherapy).
  • Active Comparator: Abiraterone acetate or Enzalutamide or Docetaxel
    Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).

Primary Outcome Measure

Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration [ Time Frame: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) ]

Locations (61)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Mayo Clinic - ArizonaPhoenixArizona85054-
Arizona Oncology Associates - USORTucsonArizona85704-
University of Southern CaliforniaBeverly HillsCalifornia90210-
Alliance Research CentersLaguna HillsCalifornia92653-
VA Greater Los Angeles Healthcare SystemLos AngelesCalifornia90073-
San Bernardino Urological AssociatesSan BernardinoCalifornia92404-
Sharp Memorial HospitalSan DiegoCalifornia92123-
Pacific Hematology Oncology AssociatesSan FranciscoCalifornia94115-
San Francisco VA Health Care SystemSan FranciscoCalifornia94121-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
St. Joseph Heritage HealthcareSanta RosaCalifornia95403-
Kaiser Permanente, Northern CAVallejoCalifornia94589-
Rocky Mountain Cancer CentersAuroraColorado80012-
Yale University School of MedicineNew HavenConnecticut06510-
Medical Oncology Hematology Consultants - USORNewarkDelaware19713-
Boca Raton Community Hospital, Inc.Boca RatonFlorida33486-
University of Florida Health Cancer CenterOrlandoFlorida32806-
Atlanta Urological GroupAtlantaGeorgia30312-
Kaiser Permanente Medical GroupHonoluluHawaii96819-
Ochsner Medical CenterNew OrleansLouisiana70121-
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201-
Walter Reed National Military Medical CenterBethesdaMaryland20889-
Maryland Oncology Hematology P.A.ColumbiaMaryland21044-
Massachusetts General HospitalBostonMassachusetts02114-
VA Ann Arbor Healthcare SystemAnn ArborMichigan48105-
Henry Ford HospitalDetroitMichigan48202-
Minnesota Oncology Hematology, P.A.MinneapolisMinnesota55404-
Minnesota Veterans Research InstituteMinneapolisMinnesota55417-
University of MinnesotaMinneapolisMinnesota55455-
Mayo Clinic - Rochester, MNRochesterMinnesota55902-
Alegent Health Bergan Mercy Hospital , GU Research NetworkOmahaNebraska68130-
Nebraska Cancer SpecialistsOmahaNebraska68130-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Premier Urology AssociatesLawrencevilleNew Jersey08648-
Roswell ParkBuffaloNew York14263-
Memorial Sloan Kettering CCNew YorkNew York10065-
NYU Perlmutter Cancer CenterNew YorkNew York10016-
Weill Cornell Medical CollegeNew YorkNew York10065-
Premier Medical Group of the Hudson Valley PCPoughkeepsieNew York12601-
University of RochesterRochesterNew York14642-
SUNY Upstate Medical UniversitySyracuseNew York13210-
University of North Carolina Lineberger Cancer CenterChapel HillNorth Carolina27599-
Carolina Urology PartnersConcordNorth Carolina28025-
Durham VA Medical CenterDurhamNorth Carolina27705-
Oncology Hematology CareCincinnatiOhio45211-
The Urology GroupCincinnatiOhio45212-
Kettering Medical CenterKetteringOhio45429-
Clinical Research SolutionsMiddleburg HeightsOhio44130-
Knight Cancer InstitutePortlandOregon97239-
Northwest Cancer Specialist DBA Compass OncologyPortlandOregon97227-
VA Portland Health Care SystemPortlandOregon97219-
Urology Associates Clinical ResearchNashvilleTennessee37209-
Urology Clinics of North TexasDallasTexas75231-
UT Southwestern Medical CenterDallasTexas75390-
UT Health Science CenterHoustonTexas77030-
Texas Oncology Cancer Center-Round RockRound RockTexas78681-
Urology of VirginiaVirginia BeachVirginia23462-
MultiCare Regional Cancer Center - Gig HarborGig HarborWashington98335-
University of Washington Fred Hutchinson Cancer Research CenterSeattleWashington98109-
VA Puget Sound HCSSeattleWashington98108-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALMayo Clinic - Arizona· Phoenix, AZArizona Oncology Associates - USOR· Tucson, AZUniversity of Southern California· Beverly Hills, CAAlliance Research Centers· Laguna Hills, CAVA Greater Los Angeles Healthcare System· Los Angeles, CA

Related Studies