A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
TRITON3
TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency
2 other identifiers
interventional
405
12 countries
150
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2017
Longer than P75 for phase_3
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedStudy Start
First participant enrolled
June 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2022
CompletedResults Posted
Study results publicly available
August 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2024
CompletedJuly 25, 2025
July 1, 2025
5.2 years
November 19, 2016
June 2, 2023
July 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration
The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined
The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria (Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Secondary Outcomes (16)
Overall Survival in Participants With a BRCA Alteration
From enrollment to completion of study (up to approximately 7 years)
Overall Survival in Participants With a BRCA or ATM Alteration Combined
From enrollment to completion of study (up to approximately 7 years)
Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Duration of Response (DOR) by IRR in Participants With a BRCA Alteration
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
- +11 more secondary outcomes
Study Arms (2)
Rucaparib
EXPERIMENTALOral rucaparib (monotherapy).
Abiraterone acetate or Enzalutamide or Docetaxel
ACTIVE COMPARATOROral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Interventions
Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
Eligibility Criteria
You may qualify if:
- Be 18 years old at the time the informed consent is signed
- 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
You may not qualify if:
- Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- pharmaand GmbHlead
- Foundation Medicinecollaborator
Study Sites (150)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Mayo Clinic - Arizona
Phoenix, Arizona, 85054, United States
Arizona Oncology Associates - USOR
Tucson, Arizona, 85704, United States
University of Southern California
Beverly Hills, California, 90210, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
San Bernardino Urological Associates
San Bernardino, California, 92404, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Pacific Hematology Oncology Associates
San Francisco, California, 94115, United States
San Francisco VA Health Care System
San Francisco, California, 94121, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, 95403, United States
Kaiser Permanente, Northern CA
Vallejo, California, 94589, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Medical Oncology Hematology Consultants - USOR
Newark, Delaware, 19713, United States
Boca Raton Community Hospital, Inc.
Boca Raton, Florida, 33486, United States
University of Florida Health Cancer Center
Orlando, Florida, 32806, United States
Atlanta Urological Group
Atlanta, Georgia, 30312, United States
Kaiser Permanente Medical Group
Honolulu, Hawaii, 96819, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Maryland Oncology Hematology P.A.
Columbia, Maryland, 21044, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
Minnesota Veterans Research Institute
Minneapolis, Minnesota, 55417, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic - Rochester, MN
Rochester, Minnesota, 55902, United States
Alegent Health Bergan Mercy Hospital , GU Research Network
Omaha, Nebraska, 68130, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Premier Urology Associates
Lawrenceville, New Jersey, 08648, United States
Roswell Park
Buffalo, New York, 14263, United States
NYU Perlmutter Cancer Center
New York, New York, 10016, United States
Memorial Sloan Kettering CC
New York, New York, 10065, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12601, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
University of North Carolina Lineberger Cancer Center
Chapel Hill, North Carolina, 27599, United States
Carolina Urology Partners
Concord, North Carolina, 28025, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Oncology Hematology Care
Cincinnati, Ohio, 45211, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Clinical Research Solutions
Middleburg Heights, Ohio, 44130, United States
VA Portland Health Care System
Portland, Oregon, 97219, United States
Northwest Cancer Specialist DBA Compass Oncology
Portland, Oregon, 97227, United States
Knight Cancer Institute
Portland, Oregon, 97239, United States
Urology Associates Clinical Research
Nashville, Tennessee, 37209, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
UT Health Science Center
Houston, Texas, 77030, United States
Texas Oncology Cancer Center-Round Rock
Round Rock, Texas, 78681, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
MultiCare Regional Cancer Center - Gig Harbor
Gig Harbor, Washington, 98335, United States
VA Puget Sound HCS
Seattle, Washington, 98108, United States
University of Washington Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Southside Cancer Care Centre
Miranda, New South Wales, 2228, Australia
Orange Health Service
Orange, New South Wales, 2800, Australia
Northern Cancer Insitute, St. Leonards
Saint Leonards, New South Wales, 2065, Australia
St John of God Hospital, Subiaco
Subiaco, Western Australia, 6008, Australia
Peninsula & Southeast Oncology
Frankston, 3199, Australia
Barwon Health, University Hospital Geelong
Geelong, 3220, Australia
Royal Hobart Hospital
Hobart, 7000, Australia
Riverina Cancer Care Centre
Wagga Wagga, 2650, Australia
ZNA Middelheim
Antwerp, 2020, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Clinique et Maternité Sainte-Elisabeth
Namur, 5000, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Centre Hospitalier Universitaire Dr-Georges-L.-Dumont
Moncton, New Brunswick, E1C 8X3, Canada
London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Lakeridge Health Medical Specialty Medical Oncology
Oshawa, L1G 2B9, Canada
Sunnybrook Odette Cancer Centre
Toronto, M4N3M5, Canada
Copenhagen University Hospital
Copenhagen, 2100, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
Centre Georges François Leclerc
Dijon, 21079, France
Clinique Victor Hugo Centre Jean Bernard
Le Mans, 72000, France
Hôpital Privé La Louvière
Lille, 59000, France
Centre Léon Bérard
Lyon, 69008, France
Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)
Nancy, 54000, France
Institut Curie
Paris, 75248, France
Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO
Plérin, 22190, France
CRLCC Eugene Marquis
Rennes, 35042, France
Institut Gustave-Roussy
Villejuif, 94805, France
Gemeinschaftspraxis für Hämatologie&Onkologie
Augsburg, 86150, Germany
Charite - Universitaetsmedizin Berlin
Berlin, 12200, Germany
Apotheke des Städtischen Klinikums Braunschweig
Braunschweig, 38102, Germany
Universitätsklinikum Köln
Cologne, 50937, Germany
University Hospital Carl Gustav Carus
Dresden, 01307, Germany
Universitatsklinikum Dusseldorf
Düsseldorf, 40225, Germany
Urologische Gemeinschaftspraxis
Emmendingen, 79312, Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246, Germany
Universitatsklinikum Jena
Jena, 07747, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Medizinischen Fakultät Mannheim der Universität Heidelberg
Mannheim, 68167, Germany
Studienpraxis Urologie
Nürtingen, 72622, Germany
University of Tuebingen
Tübingen, 72076, Germany
Die GesundheitsUnion (DGU)
Wuppertal, 42103, 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, 3109601, Israel
Hadassah University Hospital
Jerusalem, 91120, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492, Israel
The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
Tel Aviv, 6423, Israel
Chaim Sheba Medical Center
Tel Litwinsky, 5262000, Israel
Ospedale San Donato, Azienda USLSUDEST
Arezzo, 52100, Italy
Ospedale Santa Maria delle Croci
Faenza, 48018, Italy
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
Meldola, 47014, Italy
IEO Instituto Europeo di Oncologia
Milan, 20141, Italy
University of Modena and Reggio Emilia
Modena, 41124, Italy
Azienda Ospedaliera San Camillo-Forlanini
Roma, 00152, Italy
Azienda Opsedaliera S. Maria di Terni
Terni, 05100, Italy
Presidio Ospedaliero Santa Chiara di Trento
Trento, 38122, Italy
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital General Universitario de Guadalajara
Guadalajara, 19002, Spain
Hospital Universitario Lucus Augusti.
Lugo, 27004, Spain
MD Anderson Cancer Center - Madrid
Madrid, 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, 08208, Spain
Marques de Valdecilla University Hospital (HUMV)
Santander, 39008, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Instituto Valenciano de Oncología
Valencia, 46009, Spain
Guy's and St Thomas' NHS Foundation Trust
London, England, SE1 9RT, United Kingdom
Royal Marsden Hospital
London, England, SM2 5PT, United Kingdom
Oxford Cancer Centre, Medical Oncology Unit
Oxford, England, OX3 7LE, United Kingdom
Royal Preston Hospital
Preston, England, PR2 9HT, United Kingdom
Wexham Park Hospital
Slough, England, SL2 4HL, United Kingdom
Velindre Hospital
Cardiff, CF14 2TL, United Kingdom
Royal Marsden Hospital
London, SM2 5PT, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Musgrove Park Hospital
Taunton, TA15DA, United Kingdom
Related Publications (3)
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.
PMID: 36795891RESULTCollins 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.
PMID: 36898948DERIVEDMaia 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.
PMID: 32203306DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Department
- Organization
- pharmaand GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2016
First Posted
November 29, 2016
Study Start
June 13, 2017
Primary Completion
August 25, 2022
Study Completion
August 8, 2024
Last Updated
July 25, 2025
Results First Posted
August 16, 2023
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be made available to qualified researchers after the primary, secondary, and/or exploratory outcomes of the study are reported or published and for 1 year thereafter.
- Access Criteria
- Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@pharmaand.com.
De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations. Data will be provided by pharmaand GmbH.