AzTrials
AzTrials

Metastatic Castration Resistant Prostate CancerPhase 3TRITON3NCT02975934

A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

A Phase 3 study testing Rucaparib and Abiraterone acetate or Enzalutamide or Docetaxel in people with Metastatic Castration Resistant Prostate Cancer, run by pharmaand GmbH at 150 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Rucaparib and Abiraterone acetate or Enzalutamide or Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
405 participants
Where
150 sitesin 12 countries
Study dates
13 Jun 2017to 8 Aug 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

150 sites in 12 countries.

150 sites in 12 countries

United States61 sites

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48105

  • Atlanta Urological Group

    Atlanta, Georgia, 30312

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • University of Southern California

    Beverly Hills, California, 90210

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Boca Raton Community Hospital, Inc.

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Roswell Park

    Buffalo, New York, 14263

  • University of North Carolina Lineberger Cancer Center

    Chapel Hill, North Carolina, 27599

  • Oncology Hematology Care

    Cincinnati, Ohio, 45211

  • The Urology Group

    Cincinnati, Ohio, 45212

  • Maryland Oncology Hematology P.A.

    Columbia, Maryland, 21044

  • Carolina Urology Partners

    Concord, North Carolina, 28025

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • MultiCare Regional Cancer Center - Gig Harbor

    Gig Harbor, Washington, 98335

  • Kaiser Permanente Medical Group

    Honolulu, Hawaii, 96819

  • UT Health Science Center

    Houston, Texas, 77030

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Premier Urology Associates

    Lawrenceville, New Jersey, 08648

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • Clinical Research Solutions

    Middleburg Heights, Ohio, 44130

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Minnesota Veterans Research Institute

    Minneapolis, Minnesota, 55417

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Urology Associates Clinical Research

    Nashville, Tennessee, 37209

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • NYU Perlmutter Cancer Center

    New York, New York, 10016

  • Memorial Sloan Kettering CC

    New York, New York, 10065

  • Weill Cornell Medical College

    New York, New York, 10065

  • Medical Oncology Hematology Consultants - USOR

    Newark, Delaware, 19713

  • Alegent Health Bergan Mercy Hospital , GU Research Network

    Omaha, Nebraska, 68130

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • University of Florida Health Cancer Center

    Orlando, Florida, 32806

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054

  • VA Portland Health Care System

    Portland, Oregon, 97219

  • Northwest Cancer Specialist DBA Compass Oncology

    Portland, Oregon, 97227

  • Knight Cancer Institute

    Portland, Oregon, 97239

  • Premier Medical Group of the Hudson Valley PC

    Poughkeepsie, New York, 12601

  • Mayo Clinic - Rochester, MN

    Rochester, Minnesota, 55902

  • University of Rochester

    Rochester, New York, 14642

  • Texas Oncology Cancer Center-Round Rock

    Round Rock, Texas, 78681

  • San Bernardino Urological Associates

    San Bernardino, California, 92404

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115

  • San Francisco VA Health Care System

    San Francisco, California, 94121

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

  • St. Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • VA Puget Sound HCS

    Seattle, Washington, 98108

  • University of Washington Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Arizona Oncology Associates - USOR

    Tucson, Arizona, 85704

  • Kaiser Permanente, Northern CA

    Vallejo, California, 94589

  • Urology of Virginia

    Virginia Beach, Virginia, 23462

Other trials in United States

Germany14 sites

  • Gemeinschaftspraxis für Hämatologie&Onkologie

    Augsburg, 86150

  • Charite - Universitaetsmedizin Berlin

    Berlin, 12200

  • Apotheke des Städtischen Klinikums Braunschweig

    Braunschweig, 38102

  • Universitätsklinikum Köln

    Cologne, 50937

  • University Hospital Carl Gustav Carus

    Dresden, 01307

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225

  • Urologische Gemeinschaftspraxis

    Emmendingen, 79312

  • Universitaetsklinikum Hamburg-Eppendorf (UKE)

    Hamburg, 20246

  • Universitatsklinikum Jena

    Jena, 07747

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Medizinischen Fakultät Mannheim der Universität Heidelberg

    Mannheim, 68167

  • Studienpraxis Urologie

    Nürtingen, 72622

  • University of Tuebingen

    Tübingen, 72076

  • Die GesundheitsUnion (DGU)

    Wuppertal, 42103

Other trials in Germany

Spain14 sites

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario de Guadalajara

    Guadalajara, 19002

  • Hospital Universitario Lucus Augusti.

    Lugo, 27004

  • MD Anderson Cancer Center - Madrid

    Madrid, 28033

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Corporacio Sanitaria Parc Tauli

    Sabadell, 08208

  • Marques de Valdecilla University Hospital (HUMV)

    Santander, 39008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Instituto Valenciano de Oncología

    Valencia, 46009

Other trials in Spain

France9 sites

  • Centre Georges François Leclerc

    Dijon, 21079

  • Clinique Victor Hugo Centre Jean Bernard

    Le Mans, 72000

  • Hôpital Privé La Louvière

    Lille, 59000

  • Centre Léon Bérard

    Lyon, 69008

  • Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)

    Nancy, 54000

  • Institut Curie

    Paris, 75248

  • Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO

    Plérin, 22190

  • CRLCC Eugene Marquis

    Rennes, 35042

  • Institut Gustave-Roussy

    Villejuif, 94805

Other trials in France

United Kingdom9 sites

  • Velindre Hospital

    Cardiff, CF14 2TL

  • Guy's and St Thomas' NHS Foundation Trust

    London, England, SE1 9RT

  • Royal Marsden Hospital

    London, England, SM2 5PT

  • Royal Marsden Hospital

    London, SM2 5PT

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral, CH63 4JY

  • Oxford Cancer Centre, Medical Oncology Unit

    Oxford, England, OX3 7LE

  • Royal Preston Hospital

    Preston, England, PR2 9HT

  • Wexham Park Hospital

    Slough, England, SL2 4HL

  • Musgrove Park Hospital

    Taunton, TA15DA

Other trials in United Kingdom

Australia8 sites

  • Peninsula & Southeast Oncology

    Frankston, 3199

  • Barwon Health, University Hospital Geelong

    Geelong, 3220

  • Royal Hobart Hospital

    Hobart, 7000

  • Southside Cancer Care Centre

    Miranda, New South Wales, 2228

  • Orange Health Service

    Orange, New South Wales, 2800

  • Northern Cancer Insitute, St. Leonards

    Saint Leonards, New South Wales, 2065

  • St John of God Hospital, Subiaco

    Subiaco, Western Australia, 6008

  • Riverina Cancer Care Centre

    Wagga Wagga, 2650

Other trials in Australia

Canada8 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Centre Hospitalier Universitaire Dr-Georges-L.-Dumont

    Moncton, New Brunswick, E1C 8X3

  • Lakeridge Health Medical Specialty Medical Oncology

    Oshawa, L1G 2B9

  • The Ottawa Hospital

    Ottawa, Ontario, K1H8L6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • Sunnybrook Odette Cancer Centre

    Toronto, M4N3M5

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Italy8 sites

  • Ospedale San Donato, Azienda USLSUDEST

    Arezzo, 52100

  • Ospedale Santa Maria delle Croci

    Faenza, 48018

  • Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica

    Meldola, 47014

  • IEO Instituto Europeo di Oncologia

    Milan, 20141

  • University of Modena and Reggio Emilia

    Modena, 41124

  • Azienda Ospedaliera San Camillo-Forlanini

    Roma, 00152

  • Azienda Opsedaliera S. Maria di Terni

    Terni, 05100

  • Presidio Ospedaliero Santa Chiara di Trento

    Trento, 38122

Other trials in Italy

Ireland6 sites

  • Cork University Hospital

    Cork

  • Adelaide & Meath Hospital, Incorporating the National Children's Hospital

    Dublin

  • Mater Misericordiae University Hospital

    Dublin

  • Mater Private Hospital (MPH)

    Dublin

  • St James's Hospital

    Dublin

  • St. Vincent's University Hospital

    Dublin

Other trials in Ireland

Israel6 sites

  • Rambam Health Care Campus (RHCC), Rambam Medical Center

    Haifa, 3109601

  • Hadassah University Hospital

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • The Tel Aviv Sourasky Medical Center (Ichilov Hospital)

    Tel Aviv, 6423

  • Chaim Sheba Medical Center

    Tel HaShomer, 5262000

Other trials in Israel

Belgium4 sites

  • ZNA Middelheim

    Antwerp, 2020

  • AZ Groeninge

    Kortrijk, 8500

  • CHU Sart-Tilman

    Liège, 4000

  • Clinique et Maternité Sainte-Elisabeth

    Namur, 5000

Other trials in Belgium

Denmark3 sites

  • Copenhagen University Hospital

    Copenhagen, 2100

  • Herlev Hospital

    Herlev, 2730

  • Vejle Sygehus

    Vejle, 7100

Other trials in Denmark

About this study

Official title: 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.

Being tested
Rucaparib, Abiraterone acetate or Enzalutamide or Docetaxel
Keywords
CRPC, PARP inhibitor, PARPi, BRCA, ATM, HRD, TRITON, homologous recombination, DNA repair, DNA defect, DNA anomaly, germline, somatic, mCRPC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RucaparibDrug

    Also called CO-338

    Rucaparib will be administered daily.

  • Abiraterone acetate or Enzalutamide or DocetaxelDrug

    Also called Zytiga (abiraterone acetate) or Xtandi (enzalutamide) or Taxotere (docetaxel)

    Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.

Study groups in NCT02975934
Study groupRoleWhat they receive
RucaparibExperimentalOral rucaparib (monotherapy).
Receives: Drug: Rucaparib
Abiraterone acetate or Enzalutamide or DocetaxelActive comparatorOral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Receives: Drug: Abiraterone acetate or Enzalutamide or Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)

  2. 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).

    Measured: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)

Secondary outcomes (16)

  1. 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.

    Measured: From enrollment to completion of study (up to approximately 7 years)

  2. 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.

    Measured: From enrollment to completion of study (up to approximately 7 years)

  3. 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.

    Measured: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)

  4. 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.

    Measured: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)

  5. 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.

    Measured: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)

  6. 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.

    Measured: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)

  7. 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.

    Measured: From enrollment to primary completion of study (up to approximately 5 years)

  8. 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.

    Measured: From enrollment to primary completion of study (up to approximately 5 years)

  9. 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.

    Measured: From enrollment to 6 months

  10. 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.

    Measured: From enrollment to 6 months

  11. 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.

    Measured: From enrollment to primary completion of study (up to approximately 5 years)

  12. 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.

    Measured: From enrollment to primary completion of study (up to approximately 5 years)

  13. 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.

    Measured: From enrollment to up to approximately 25 weeks

  14. 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.

    Measured: From enrollment to up to approximately 25 weeks

  15. 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.

    Measured: From enrollment to up to approximately 25 weeks

  16. 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.

    Measured: From enrollment to week 5 of dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2016 (estimated)
  2. Study start13 Jun 2017
  3. Primary completion25 Aug 2022
  4. Study completion8 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02975934
Sponsor's protocol ID
CO-338-063
Other IDs
2016-003163-20, 2016
Acronym
TRITON3
Status last verified
Jul 2025
First submitted
19 Nov 2016
Last updated
25 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36795891

  • 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.

    PubMed 36898948

  • 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.

    PubMed 32203306

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rucaparib and Abiraterone acetate or Enzalutamide or Docetaxel in people with Metastatic Castration Resistant Prostate Cancer, run by pharmaand GmbH at 150 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, Germany, Spain, France, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration (time frame: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02975934, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.

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