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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Castration Resistant Prostate Cancer
• Intervention / Treatment: Drug: Rucaparib; Drug: Abiraterone acetate or Enzalutamide or Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 405
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Frankston, Australia, 3199
    • Peninsula & Southeast Oncology
  • Geelong, Australia, 3220
    • Barwon Health, University Hospital Geelong
  • Hobart, Australia, 7000
    • Royal Hobart Hospital
  • Wagga Wagga, Australia, 2650
    • Riverina Cancer Care Centre
  • New South Wales
    • Miranda, New South Wales, Australia, 2228
      • Southside Cancer Care Centre
    • Orange, New South Wales, Australia, 2800
      • Orange Health Service
    • Saint Leonards, New South Wales, Australia, 2065
      • Northern Cancer Insitute, St. Leonards
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • St John of God Hospital, Subiaco
• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
  • Namur, Belgium, 5000
    • Clinique et Maternité Sainte-Elisabeth
• Canada
  • Oshawa, Canada, L1G 2B9
    • Lakeridge Health Medical Specialty Medical Oncology
  • Toronto, Canada, M4N3M5
    • Sunnybrook Odette Cancer Centre
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Cancer Care Manitoba
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Centre Hospitalier Universitaire Dr-Georges-L.-Dumont
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1H8L6
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
• Denmark
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital
  • Herlev, Denmark, 2730
    • Herlev Hospital
  • Vejle, Denmark, 7100
    • Vejle Sygehus
• France
  • Dijon, France, 21079
    • Centre Georges François Leclerc
  • Le Mans, France, 72000
    • Clinique Victor Hugo Centre Jean Bernard
  • Lille, France, 59000
    • Hôpital Privé La Louvière
  • Lyon, France, 69008
    • Centre Léon Bérard
  • Nancy, France, 54000
    • Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)
  • Paris, France, 75248
    • Institut Curie
  • Plérin, France, 22190
    • Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO
  • Rennes, France, 35042
    • CRLCC Eugene Marquis
  • Villejuif, France, 94805
    • Institut Gustave-Roussy
• Germany
  • Augsburg, Germany, 86150
    • Gemeinschaftspraxis für Hämatologie&Onkologie
  • Berlin, Germany, 12200
    • Charite - Universitaetsmedizin Berlin
  • Braunschweig, Germany, 38102
    • Apotheke des Städtischen Klinikums Braunschweig
  • Dresden, Germany, 01307
    • University Hospital Carl Gustav Carus
  • Dusseldorf, Germany, 40225
    • Universitatsklinikum Dusseldorf
  • Emmendingen, Germany, 79312
    • Urologische Gemeinschaftspraxis
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf (UKE)
  • Jena, Germany, 07747
    • Universitätsklinikum Jena
  • Köln, Germany, 50937
    • Universitätsklinikum Köln
  • Lubeck, Germany, 23538
    • Universitatsklinikum Schleswig-Holstein
  • Mannheim, Germany, 68167
    • Medizinischen Fakultät Mannheim der Universität Heidelberg
  • Nurtingen, Germany, 72622
    • Studienpraxis Urologie
  • Tuebingen, Germany, 72076
    • University of Tuebingen
  • Wuppertal, Germany, 42103
    • Die GesundheitsUnion (DGU)
• Ireland
  • Cork, Ireland
    • Cork University Hospital
  • Dublin, Ireland
    • Mater Misericordiae University Hospital
  • Dublin, Ireland
    • St James's Hospital
  • Dublin, Ireland
    • St. Vincent's University Hospital
  • Dublin, Ireland
    • Adelaide & Meath Hospital, Incorporating the National Children's Hospital
  • Dublin, Ireland
    • Mater Private Hospital (MPH)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus (RHCC), Rambam Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah University Hospital
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center-Beilinson Campus
  • Tel Aviv, Israel, 6423
    • The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
  • Tel Hashomer, Israel, 5262000
    • Chaim Sheba Medical Center
• Italy
  • Arezzo, Italy, 52100
    • Ospedale San Donato, Azienda USLSUDEST
  • Faenza, Italy, 48018
    • Ospedale Santa Maria Delle Croci
  • Meldola, Italy, 47014
    • Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
  • Milano, Italy, 20141
    • IEO Instituto Europeo di Oncologia
  • Modena, Italy, 41124
    • University of Modena and Reggio Emilia
  • Roma, Italy, 00152
    • Azienda Ospedaliera San Camillo-Forlanini
  • Terni, Italy, 05100
    • Azienda Opsedaliera S. Maria di Terni
  • Trento, Italy, 38122
    • Presidio Ospedaliero Santa Chiara di Trento
• Spain
  • Barcelona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Guadalajara, Spain, 19002
    • Hospital General Universitario de Guadalajara
  • Lugo, Spain, 27004
    • Hospital Universitario Lucus Augusti.
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center - Madrid
  • Málaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias
  • Sabadell, Spain, 08208
    • Corporacio Sanitaria Parc Tauli
  • Santander, Spain, 39008
    • Marques de Valdecilla University Hospital (HUMV)
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
• United Kingdom
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Hospital
  • London, United Kingdom, SM2 5PT
    • Royal Marsden Hospital
  • Taunton, United Kingdom, TA15DA
    • Musgrove Park Hospital
  • Wirral, United Kingdom, CH63 4JY
    • The Clatterbridge Cancer Centre NHS Foundation Trust
  • England
    • London, England, United Kingdom, SE1 9RT
      • Guy's and St Thomas' NHS Foundation Trust
    • London, England, United Kingdom, SM2 5PT
      • Royal Marsden Hospital
    • Oxford, England, United Kingdom, OX3 7LE
      • Oxford Cancer Centre, Medical Oncology Unit
    • Preston, England, United Kingdom, PR2 9HT
      • Royal Preston Hospital
    • Slough, England, United Kingdom, SL2 4HL
      • Wexham Park Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic - Arizona
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates - USOR
  • California
    • Beverly Hills, California, United States, 90210
      • University of Southern California
    • Laguna Hills, California, United States, 92653
      • Alliance Research Centers
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System
    • San Bernardino, California, United States, 92404
      • San Bernardino Urological Associates
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • San Francisco, California, United States, 94121
      • San Francisco VA Health Care System
    • San Francisco, California, United States, 94115
      • Pacific Hematology Oncology Associates
    • San Francisco, California, United States, 94158
      • UCSF Helen Diller Family Comprehensive Cancer Center
    • Santa Rosa, California, United States, 95403
      • St. Joseph Heritage Healthcare
    • Vallejo, California, United States, 94589
      • Kaiser Permanente, Northern CA
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School Of Medicine
  • Delaware
    • Newark, Delaware, United States, 19713
      • Medical Oncology Hematology Consultants - USOR
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Community Hospital, Inc.
    • Orlando, Florida, United States, 32806
      • University of Florida Health Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30312
      • Atlanta Urological Group
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Permanente Medical Group
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Greenebaum Cancer Center
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Hematology P.A.
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Ann Arbor Healthcare System
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology, P.A.
    • Minneapolis, Minnesota, United States, 55417
      • Minnesota Veterans Research Institute
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic - Rochester, Mn
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Nebraska Cancer Specialists
    • Omaha, Nebraska, United States, 68130
      • Alegent Health Bergan Mercy Hospital , GU Research Network
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Premier Urology Associates
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • New York, New York, United States, 10016
      • NYU Perlmutter Cancer Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering CC
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of the Hudson Valley PC
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Lineberger Cancer Center
    • Concord, North Carolina, United States, 28025
      • Carolina Urology Partners
    • Durham, North Carolina, United States, 27705
      • Durham VA Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • The Urology Group
    • Cincinnati, Ohio, United States, 45211
      • Oncology Hematology Care
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Solutions
  • Oregon
    • Portland, Oregon, United States, 97219
      • VA Portland Health Care System
    • Portland, Oregon, United States, 97227
      • Northwest Cancer Specialist DBA Compass Oncology
    • Portland, Oregon, United States, 97239
      • Knight Cancer Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37209
      • Urology Associates Clinical Research
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
    • Houston, Texas, United States, 77030
      • UT Health Science Center
    • Round Rock, Texas, United States, 78681
      • Texas Oncology Cancer Center-Round Rock
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia
  • Washington
    • Gig Harbor, Washington, United States, 98335
      • MultiCare Regional Cancer Center - Gig Harbor
    • Seattle, Washington, United States, 98108
      • VA Puget Sound HCS
    • Seattle, Washington, United States, 98109
      • University of Washington Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rucaparib; Oral rucaparib (monotherapy).	Drug: Rucaparib; Rucaparib will be administered daily.; Other Names: CO-338
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).	Drug: Abiraterone acetate or Enzalutamide or Docetaxel; Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.; Other Names: Zytiga (abiraterone acetate) or Xtandi (enzalutamide) or Taxotere (docetaxel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interim Overall Survival in Participants With a BRCA Alteration	Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participant was last known to be alive.	From enrollment to primary completion of study (up to approximately 5 years)
Interim Overall Survival in Participants With a BRCA or ATM Alteration Combined	Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participants was last known to be alive.	From enrollment to primary completion of study (up to approximately 5 years)
Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration	ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment). 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 of diameters.	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	ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment). 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 of diameters.	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	DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented.	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 or ATM Alteration Combined	DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented.	From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
PSA Response in Participants With a BRCA Alteration	Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory.	From enrollment to primary completion of study (up to approximately 5 years)
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration	Defined as the percentage of participants 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.	From enrollment to 6 months
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined	Defined as the percentage of participants 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.	From enrollment to 6 months
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration	Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.	From enrollment to primary completion of study (up to approximately 5 years)
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined	Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.	From enrollment to primary completion of study (up to approximately 5 years)
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P	Changes in health and pain status from baseline to week 25 using: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P total score, on a scale of 0 to 156 where a higher score is better quality of life). The greater the decrease in score (ie more negative) from baseline to week 25 the greater the decrease in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.	From enrollment to up to approximately 25 weeks
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF	Changes in health and pain status from baseline to week 25 using: Brief Pain Inventory-Short Form (BPI-SF) questionnaire (on a scale of 1 to 10, from mild to severe, for pain and pain-interference scores). A decrease indicates less severe pain/interference. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.	From enrollment to up to approximately 25 weeks
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L	Changes in health and pain status from baseline to week 25 using: EuroQol-5D-5L Visual Analogue Scale (EQ-5D-5L VAS; on a scale from 100 to 0, from best to worst health status). The greater the increase in score (including more negative) from baseline to week 25 the greater the increase in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.	From enrollment to up to approximately 25 weeks
Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling	Mean trough PK plasma concentration over time in the safety population with at least one PK sample collected at timepoints week 5, 9, 13 and 17; only Week 5 data presented.	From enrollment to week 5 of dosing
PSA Response in Participants With a BRCA or ATM Alteration Combined	Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory.	From enrollment to primary completion of study (up to approximately 5 years)

Collaborators and Investigators

• Sponsor: pharmaand GmbH
• Collaborators: Foundation Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2017
• Primary Completion (Actual): August 25, 2022
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 19, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (Estimated): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: PARP inhibitor; mCRPC; CRPC; BRCA; PARPi; germline; HRD; homologous recombination; DNA defect; ATM; DNA repair; DNA anomaly; somatic; TRITON
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Hormones, Hormone Substitutes, and Hormone Antagonists; Poly(ADP-ribose) Polymerase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Docetaxel; Rucaparib; Abiraterone Acetate
• Other Study ID Numbers: CO-338-063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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 zr pharma& Austria GmbH

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No