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


Condition: Metastatic Castration Resistant Prostate Cancer

Intervention:

  • Drug: Rucaparib
  • Drug: Abiraterone acetate or Enzalutamide or Docetaxel

Purpose: The purpose of this study is to determine how patients 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02975934

Sponsor: Clovis Oncology, Inc.

Primary Outcome Measures:

  • Measure: Radiographic Progression-free Survival (rPFS)
  • Time Frame: From enrollment to primary completion of study (up to approximately 5 years)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Objective Response Rate (ORR)
  • Time Frame: From enrollment to primary completion of study (up to approximately 5 years)
  • Safety Issue:
  • Measure: Duration of Response (DOR)
  • Time Frame: From enrollment to primary completion of study (up to approximately 5 years)
  • Safety Issue:
  • Measure: Time to Prostate Specific Antigen (PSA) Progression
  • Time Frame: From enrollment to primary completion of study (up to approximately 5 years)
  • Safety Issue:
  • Measure: PSA Response
  • Time Frame: From enrollment to primary completion of study (up to approximately 5 years)
  • Safety Issue:
  • Measure: Change in Patient-reported Outcome (PRO)
  • Time Frame: From enrollment to primary completion of study (up to approximately 5 years)
  • Safety Issue:
  • Measure: Clinical Benefit Rate (CBR), defined as the percentage of patients with a complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST Version 1.1 with no progression in bone per PCWG3 criteria
  • Time Frame: From enrollment to primary completion of study (up to approximately 5 years)
  • Safety Issue:
  • Measure: Overall Survival
  • Time Frame: From enrollment to primary completion of study (up to approximately 5 years)
  • Safety Issue:
  • Measure: Trough plasma PK (Cmin) of rucaparib based on sparse sampling
  • Time Frame: From enrollment to primary completion of study (up to approximately 5 years)
  • Safety Issue:
  • Measure: Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
  • Time Frame: From enrollment to primary completion of study (up to approximately 5 years)
  • Safety Issue:

Estimated Enrollment: 400

Study Start Date: June 13, 2017

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 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 for castration-resistant disease
  • Have a deleterious mutation in a BRCA1/2 or ATM gene

Exclusion Criteria:

  • 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:

  • Clovis Oncology Clinical Trial Navigation Service
  • 1-855-262-3040 (USA)

Locations:

  • 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
  • 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
  • University Hospital Carl Gustav Carus
  • Dresden 01307 Germany
  • Universitatsklinikum Dusseldorf
  • Dusseldorf 40225 Germany
  • Urologische Gemeinschaftspraxis
  • Emmendingen 79312 Germany
  • Universitaetsklinikum Hamburg-Eppendorf (UKE)
  • Hamburg 20246 Germany
  • Universitatsklinikum Jena
  • Jena 07747 Germany
  • Universitätsklinikum Köln
  • Köln 50937 Germany
  • Universitätsklinikum Schleswig-Holstein
  • Lubeck 23538 Germany
  • Medizinischen Fakultät Mannheim der Universität Heidelberg
  • Mannheim 68167 Germany
  • Studienpraxis Urologie
  • Nurtingen 72622 Germany
  • University of Tuebingen
  • Tuebingen 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
  • Petach Tikva 4941492 Israel
  • The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
  • Tel Aviv 6423 Israel
  • Chaim Sheba Medical Center
  • Tel Hashomer 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
  • Milano 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
  • Sevilla 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
  • Musgrove Park Hospital
  • Taunton TA15DA United Kingdom
  • The Clatterbridge Cancer Centre NHS Foundation Trust
  • Wirral CH63 4JY United Kingdom

View trial on ClinicalTrials.gov