A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
TRITON2
TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency
2 other identifiers
interventional
277
12 countries
149
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2017
Typical duration for phase_2
149 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
October 24, 2016
CompletedFirst Posted
Study publicly available on registry
November 2, 2016
CompletedStudy Start
First participant enrolled
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2021
CompletedResults Posted
Study results publicly available
June 8, 2022
CompletedJune 9, 2023
June 1, 2023
4.4 years
October 24, 2016
April 12, 2022
June 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR)
The primary efficacy endpoint is confirmed radiographic ORR by central IRR. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Secondary Outcomes (12)
Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Investigator (INV)
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Central Independent Radiology Review (IRR)
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Investigator
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Confirmed PSA Response (≥ 50% Decrease) by Gene as Assessed by Local Laboratory
PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.
Confirmed PSA Response (≥ 90% Decrease) by Gene as Assessed by Local Laboratory
PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.
- +7 more secondary outcomes
Study Arms (1)
Rucaparib
EXPERIMENTALOral rucaparib (monotherapy)
Interventions
Eligibility Criteria
You may qualify if:
- Be 18 years old at the time the informed consent form is signed
- Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate
- Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
- Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease
- Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency
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, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy
- 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 rucaparib
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- pharmaand GmbHlead
- Foundation Medicinecollaborator
Study Sites (149)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinc
Phoenix, Arizona, 85259, United States
Arizona Oncology Associates
Tucson, Arizona, 85704, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
University of Southern California
Los Angeles, California, 90211, United States
Stanford University
Palo Alto, California, 94305, 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, 94143, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
Redwood Regional Medical Group
Santa Rosa, California, 95406, United States
Kaiser Permanente Medical Center (Vallejo)
Vallejo, California, 94589, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
Yale School of Medicine
New Haven, Connecticut, 06510, United States
4701 Ogletown Stanton Rd.
Newark, Delaware, 19713, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Boca Raton Community Hospital, Inc.
Boca Raton, Florida, 33486, United States
Florida Cancer Specialists
Fort Myers, Florida, 33980, United States
University of Florida Health Cancer Center
Orlando, Florida, 32806, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Atlanta Urological Group
Atlanta, Georgia, 30312, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Walter Reed Hospital
Bethesda, Maryland, 48202, 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
Fairview Hospital
Edina, Minnesota, 55435, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
Minnesota Veterans Research Institute
Minneapolis, Minnesota, 55417, United States
HCA Midwest Division - Kansas City
Kansas City, Missouri, 64132, 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, 89119, United States
Premier Urology Associates dba/AdvanceMed Research
Lawrenceville, New Jersey, 08648, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, 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/NewYork-Presbyterian Hospital
New York, New York, 10065, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12301, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Carolina Urology Partners
Concord, North Carolina, 28025, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Kettering Cancer 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
Consultants in Medical Oncology Hematology
Horsham, Pennsylvania, 19044, United States
SCRI - Tennessee Oncology
Nashville, Tennessee, 37203, United States
Texas Oncology Medical City Dallas
Dallas, Texas, 75320, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
UT Health Science Center
Houston, Texas, 77030, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
VA Puget Sound
Seattle, Washington, 98108, United States
Northern Cancer Insitute, St. Leonards
Saint Leonards, New South Wales, 2065, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Peninsula & Southeast Oncology
Frankston, Victoria, 3199, Australia
Barwon Health, University Hospital Geelong
Geelong, Victoria, 3220, Australia
Cabrini Hospital
Malvern, Victoria, 3144, Australia
Southside Cancer Care Centre
Miranda, 2228, Australia
Orange Health Services
Orange, 2800, Australia
St John of God Hospital, Subiaco
Subiaco, 6008, Australia
Riverina Cancer Care Centre
Wagga Wagga, 2650, Australia
ZNA Middelheim
Antwerp, 2020, Belgium
Universitair Ziekenhuis Gent
Ghent, B-9000, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Equipe de Recherche Clinique, Département d'Oncologie/Hématologie
Liège, 4000, Belgium
AZ DELTA
Roeselare, B-8800, Belgium
Juravinski Cancer Centre Hamilton Health Services
Hamilton, Ontario, L8V5C2, Canada
London Health Science Center - Victoria Hospital
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H8L6, Canada
Princess Margaret Hospital
Toronto, M5G 2M9, Canada
Copenhagen University Hospital
Copenhagen, 2100, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
Centre François Baclesse
Caen, 14000, France
Centre Georges François Leclerc
Dijon, 21079, France
Clinique Victor Hugo Centre Jean Bernard
Le Mans, 72000, France
Hôpital Privé La Louvière
Lille, 59800, France
Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)
Nancy, 54100, France
Institut Curie
Paris, 75248, France
Hôpital Privé des Côtes d'Armor
Plérin, 22190, France
CRLCC Eugene Marquis
Rennes, 35042, France
Gemeinschaftspraxis fur Hamatologie & Onkologie
Augsburg, 86150, Germany
Charite Universitatsmedizin Berlin
Berlin, 12200, Germany
Universitätsklinik Köln
Cologne, 50937, Germany
Universitatsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Universitatsklinikum Dusseldorf
Düsseldorf, 40225, Germany
Urologische Gemeinschaftspraxis
Emmendingen, 79312, Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, 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 Gesundhehitsunion DGU
Wuppertal, 42103, Germany
Cork University Hospital
Cork, T12 DFK4, Ireland
St. Vincent's University Hospital
Dublin, D04T6F4, Ireland
St James's Hospital
Dublin, D08 NHY1, Ireland
Adelaide & Meath Hospital, Incorporating the National Children's Hospital
Dublin, Dublin 24, Ireland
Mater Misericordiae University Hospital
Dublin, Dublin 7, Ireland
Rambam Health Care Campus (RHCC), Rambam Medical Center
Haifa, 3109601, Israel
Hadassah University Hospital
Jerusalem, 71120, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
Tel Aviv, 64231, Israel
Ospedale San Donato, Azienda USLSUDEST
Arezzo, 52100, Italy
Ospedale Santa Maria delle Croci
Faenza, 48018, Italy
IRCCS Istituto Nazionale dei Tumori (INT)
Milan, 20133, Italy
IEO Instituto Europeo di Oncologia
Milan, 20141, Italy
University of Modena and Reggio Emilia Medical Oncology
Modena, 41124, Italy
Azienda Ospedaliera San Camillo-Forlanini
Rome, 00152, Italy
Azienda Opsedaliera S. Maria di Terni
Terni, 05100, Italy
Santa Chiara Hospital, Dept Medical Oncology
Trento, 38122, Italy
Hospital Universitari Germans Trias i Pujol
Badalona, 08916, Spain
Hospital del Mar, Servicio de Oncología
Barcelona, 08003, Spain
Hospital Clínic i Provincial de Barcelona-Oncology
Barcelona, 08036, Spain
Instituto Catalan de Oncologia
Barcelona, 08908, Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital General Universitario de Guadalajara
Guadalajara, 19002, Spain
Hospital Universitario Lucus Augusti.
Lugo, 27003, 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 Puerta de Hierro-Majadahonda
Madrid, 28222, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, 8208, Spain
Marques de Valdecilla University Hospital (HUMV)
Santander, 39008, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Instituto Valenciano de Oncologia IVO
Valencia, 46009, Spain
Wexham Park Hospital
Slough, Berkshire, SL2 4HL, United Kingdom
Mount Vernon Cancer Centre
Northwood, England, HA6 2RN, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
Oxford University Hospitals
Headington, OC3 7LJ, United Kingdom
Royal Liverpool Hospital
Liverpool, L7 8XP, United Kingdom
London Health Science Center - Victoria Hospital
London, N6A 4L6, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Sarah Cannon Research Institutute - UK
London, W1G 6AD, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Musgrove Park Hospital
Taunton, TA1 5DA, United Kingdom
Related Publications (4)
Abida W, Campbell D, Patnaik A, Bryce AH, Shapiro J, Bambury RM, Zhang J, Burke JM, Castellano D, Font A, Ganju V, Hardy-Bessard AC, McDermott R, Sautois B, Spaeth D, Voog E, Piulats JM, Pintus E, Ryan CJ, Merseburger AS, Daugaard G, Heidenreich A, Fizazi K, Loehr A, Despain D, Simmons AD, Dowson M, Go J, Watkins SP, Chowdhury S. Rucaparib for the Treatment of Metastatic Castration-resistant Prostate Cancer Associated with a DNA Damage Repair Gene Alteration: Final Results from the Phase 2 TRITON2 Study. Eur Urol. 2023 Sep;84(3):321-330. doi: 10.1016/j.eururo.2023.05.021. Epub 2023 Jun 3.
PMID: 37277275DERIVEDCollins 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: 36898948DERIVEDGreen ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.
PMID: 35397664DERIVEDMaia 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
Conditions
Interventions
Results Point of Contact
- Title
- Medical Information Department
- Organization
- Clovis Oncology, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2016
First Posted
November 2, 2016
Study Start
February 15, 2017
Primary Completion
July 18, 2021
Study Completion
July 27, 2021
Last Updated
June 9, 2023
Results First Posted
June 8, 2022
Record last verified: 2023-06
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@clovisoncology.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 Clovis Oncology.