A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
NCT ID: NCT02975934
Last Updated: 2025-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
405 participants
INTERVENTIONAL
2017-06-13
2024-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rucaparib
Oral rucaparib (monotherapy).
Rucaparib
Rucaparib will be administered daily.
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).
Abiraterone acetate or Enzalutamide or Docetaxel
Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
Interventions
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Rucaparib
Rucaparib will be administered daily.
Abiraterone acetate or Enzalutamide or Docetaxel
Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic
* Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
* Be eligible for treatment with physician's choice of comparator treatment (abiraterone acetate, enzalutamide or docetaxel)
* Experienced disease progression after having received 1 prior next generation androgen receptor-targeted therapy
* Have a deleterious mutation in a BRCA1/2 or ATM gene
Exclusion Criteria
* Prior treatment with any PARP inhibitor
* Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
* Symptomatic and/or untreated central nervous system metastases
* Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug
18 Years
MALE
No
Sponsors
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Foundation Medicine
INDUSTRY
pharmaand GmbH
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic - Arizona
Phoenix, Arizona, United States
Arizona Oncology Associates - USOR
Tucson, Arizona, United States
University of Southern California
Beverly Hills, California, United States
Alliance Research Centers
Laguna Hills, California, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
San Bernardino Urological Associates
San Bernardino, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
San Francisco VA Health Care System
San Francisco, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, United States
Kaiser Permanente, Northern CA
Vallejo, California, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Medical Oncology Hematology Consultants - USOR
Newark, Delaware, United States
Boca Raton Community Hospital, Inc.
Boca Raton, Florida, United States
University of Florida Health Cancer Center
Orlando, Florida, United States
Atlanta Urological Group
Atlanta, Georgia, United States
Kaiser Permanente Medical Group
Honolulu, Hawaii, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Maryland Oncology Hematology P.A.
Columbia, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
Minnesota Veterans Research Institute
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester, MN
Rochester, Minnesota, United States
Alegent Health Bergan Mercy Hospital , GU Research Network
Omaha, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Premier Urology Associates
Lawrenceville, New Jersey, United States
Roswell Park
Buffalo, New York, United States
NYU Perlmutter Cancer Center
New York, New York, United States
Memorial Sloan Kettering CC
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, United States
University of Rochester
Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
University of North Carolina Lineberger Cancer Center
Chapel Hill, North Carolina, United States
Carolina Urology Partners
Concord, North Carolina, United States
Durham VA Medical Center
Durham, North Carolina, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
The Urology Group
Cincinnati, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Clinical Research Solutions
Middleburg Heights, Ohio, United States
VA Portland Health Care System
Portland, Oregon, United States
Northwest Cancer Specialist DBA Compass Oncology
Portland, Oregon, United States
Knight Cancer Institute
Portland, Oregon, United States
Urology Associates Clinical Research
Nashville, Tennessee, United States
Urology Clinics of North Texas
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
UT Health Science Center
Houston, Texas, United States
Texas Oncology Cancer Center-Round Rock
Round Rock, Texas, United States
Urology of Virginia
Virginia Beach, Virginia, United States
MultiCare Regional Cancer Center - Gig Harbor
Gig Harbor, Washington, United States
VA Puget Sound HCS
Seattle, Washington, United States
University of Washington Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Southside Cancer Care Centre
Miranda, New South Wales, Australia
Orange Health Service
Orange, New South Wales, Australia
Northern Cancer Insitute, St. Leonards
Saint Leonards, New South Wales, Australia
St John of God Hospital, Subiaco
Subiaco, Western Australia, Australia
Peninsula & Southeast Oncology
Frankston, , Australia
Barwon Health, University Hospital Geelong
Geelong, , Australia
Royal Hobart Hospital
Hobart, , Australia
Riverina Cancer Care Centre
Wagga Wagga, , Australia
ZNA Middelheim
Antwerp, , Belgium
AZ Groeninge
Kortrijk, , Belgium
CHU Sart-Tilman
Liège, , Belgium
Clinique et Maternité Sainte-Elisabeth
Namur, , Belgium
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Centre Hospitalier Universitaire Dr-Georges-L.-Dumont
Moncton, New Brunswick, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Lakeridge Health Medical Specialty Medical Oncology
Oshawa, , Canada
Sunnybrook Odette Cancer Centre
Toronto, , Canada
Copenhagen University Hospital
Copenhagen, , Denmark
Herlev Hospital
Herlev, , Denmark
Vejle Sygehus
Vejle, , Denmark
Centre Georges François Leclerc
Dijon, , France
Clinique Victor Hugo Centre Jean Bernard
Le Mans, , France
Hôpital Privé La Louvière
Lille, , France
Centre Léon Bérard
Lyon, , France
Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)
Nancy, , France
Institut Curie
Paris, , France
Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO
Plérin, , France
CRLCC Eugene Marquis
Rennes, , France
Institut Gustave-Roussy
Villejuif, , France
Gemeinschaftspraxis für Hämatologie&Onkologie
Augsburg, , Germany
Charite - Universitaetsmedizin Berlin
Berlin, , Germany
Apotheke des Städtischen Klinikums Braunschweig
Braunschweig, , Germany
Universitätsklinikum Köln
Cologne, , Germany
University Hospital Carl Gustav Carus
Dresden, , Germany
Universitatsklinikum Dusseldorf
Düsseldorf, , Germany
Urologische Gemeinschaftspraxis
Emmendingen, , Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE)
Hamburg, , Germany
Universitatsklinikum Jena
Jena, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Medizinischen Fakultät Mannheim der Universität Heidelberg
Mannheim, , Germany
Studienpraxis Urologie
Nürtingen, , Germany
University of Tuebingen
Tübingen, , Germany
Die GesundheitsUnion (DGU)
Wuppertal, , Germany
Cork University Hospital
Cork, , Ireland
Adelaide & Meath Hospital, Incorporating the National Children's Hospital
Dublin, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
Mater Private Hospital (MPH)
Dublin, , Ireland
St James's Hospital
Dublin, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
Rambam Health Care Campus (RHCC), Rambam Medical Center
Haifa, , Israel
Hadassah University Hospital
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, , Israel
The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
Tel Aviv, , Israel
Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Ospedale San Donato, Azienda USLSUDEST
Arezzo, , Italy
Ospedale Santa Maria delle Croci
Faenza, , Italy
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
Meldola, , Italy
IEO Instituto Europeo di Oncologia
Milan, , Italy
University of Modena and Reggio Emilia
Modena, , Italy
Azienda Ospedaliera San Camillo-Forlanini
Roma, , Italy
Azienda Opsedaliera S. Maria di Terni
Terni, , Italy
Presidio Ospedaliero Santa Chiara di Trento
Trento, , Italy
Hospital Universitari Germans Trias i Pujol
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital General Universitario de Guadalajara
Guadalajara, , Spain
Hospital Universitario Lucus Augusti.
Lugo, , Spain
MD Anderson Cancer Center - Madrid
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Corporacio Sanitaria Parc Tauli
Sabadell, , Spain
Marques de Valdecilla University Hospital (HUMV)
Santander, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Instituto Valenciano de Oncología
Valencia, , Spain
Guy's and St Thomas' NHS Foundation Trust
London, England, United Kingdom
Royal Marsden Hospital
London, England, United Kingdom
Oxford Cancer Centre, Medical Oncology Unit
Oxford, England, United Kingdom
Royal Preston Hospital
Preston, England, United Kingdom
Wexham Park Hospital
Slough, England, United Kingdom
Velindre Hospital
Cardiff, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Countries
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References
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Fizazi K, Piulats JM, Reaume MN, Ostler P, McDermott R, Gingerich JR, Pintus E, Sridhar SS, Bambury RM, Emmenegger U, Lindberg H, Morris D, Nole F, Staffurth J, Redfern C, Saez MI, Abida W, Daugaard G, Heidenreich A, Krieger L, Sautois B, Loehr A, Despain D, Heyes CA, Watkins SP, Chowdhury S, Ryan CJ, Bryce AH; TRITON3 Investigators. Rucaparib or Physician's Choice in Metastatic Prostate Cancer. N Engl J Med. 2023 Feb 23;388(8):719-732. doi: 10.1056/NEJMoa2214676. Epub 2023 Feb 16.
Collins K, Cheng L. Reprint of: morphologic spectrum of treatment-related changes in prostate tissue and prostate cancer: an updated review. Hum Pathol. 2023 Mar;133:92-101. doi: 10.1016/j.humpath.2023.02.007. Epub 2023 Mar 8.
Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003163-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CO-338-063
Identifier Type: -
Identifier Source: org_study_id
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