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Metastatic Castration Resistant Prostate CancerPhase 2TRITON2NCT02952534

A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

A Phase 2 study testing Rucaparib in people with Metastatic Castration Resistant Prostate Cancer, run by pharmaand GmbH at 149 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 patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Rucaparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
277 participants
Where
149 sitesin 12 countries
Study dates
15 Feb 2017to 27 Jul 2021
Phase
Phase 2
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 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

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, 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

Trial locations and contacts

149 sites in 12 countries.

149 sites in 12 countries

United States58 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 Hospital

    Bethesda, Maryland, 48202

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Boca Raton Community Hospital, Inc.

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Roswell Park

    Buffalo, New York, 14263

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • The Urology Group

    Cincinnati, Ohio, 45212

  • Carolina Urology Partners

    Concord, North Carolina, 28025

  • Texas Oncology Medical City Dallas

    Dallas, Texas, 75320

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Fairview Hospital

    Edina, Minnesota, 55435

  • Florida Cancer Specialists

    Fort Myers, Florida, 33980

  • Consultants in Medical Oncology Hematology

    Horsham, Pennsylvania, 19044

  • UT Health Science Center

    Houston, Texas, 77030

  • HCA Midwest Division - Kansas City

    Kansas City, Missouri, 64132

  • Kettering Cancer Center

    Kettering, Ohio, 45429

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89119

  • Premier Urology Associates dba/AdvanceMed Research

    Lawrenceville, New Jersey, 08648

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • University of Southern California

    Los Angeles, California, 90211

  • Clinical Research Solutions

    Middleburg Heights, Ohio, 44130

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Minnesota Veterans Research Institute

    Minneapolis, Minnesota, 55417

  • SCRI - Tennessee Oncology

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Yale 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/NewYork-Presbyterian Hospital

    New York, New York, 10065

  • 4701 Ogletown Stanton Rd.

    Newark, Delaware, 19713

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • 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

  • Stanford University

    Palo Alto, California, 94305

  • Mayo Clinc

    Phoenix, Arizona, 85259

  • VA Portland Health Care System

    Portland, Oregon, 97219

  • Premier Medical Group of the Hudson Valley PC

    Poughkeepsie, New York, 12301

  • University of Rochester

    Rochester, New York, 14642

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115

  • San Francisco VA Health Care System

    San Francisco, California, 94143

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

  • Redwood Regional Medical Group

    Santa Rosa, California, 95406

  • VA Puget Sound

    Seattle, Washington, 98108

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Arizona Oncology Associates

    Tucson, Arizona, 85704

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Kaiser Permanente Medical Center (Vallejo)

    Vallejo, California, 94589

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Spain17 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Hospital del Mar, Servicio de Oncología

    Barcelona, 08003

  • Hospital Clínic i Provincial de Barcelona-Oncology

    Barcelona, 08036

  • Instituto Catalan de Oncologia

    Barcelona, 08908

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

  • Hospital General Universitario de Guadalajara

    Guadalajara, 19002

  • Hospital Universitario Lucus Augusti.

    Lugo, 27003

  • 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 Puerta de Hierro-Majadahonda

    Madrid, 28222

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Corporacio Sanitaria Parc Tauli

    Sabadell, 8208

  • Marques de Valdecilla University Hospital (HUMV)

    Santander, 39008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Instituto Valenciano de Oncologia IVO

    Valencia, 46009

Other trials in Spain

Germany14 sites

  • Gemeinschaftspraxis fur Hamatologie & Onkologie

    Augsburg, 86150

  • Charite Universitatsmedizin Berlin

    Berlin, 12200

  • Universitätsklinik Köln

    Cologne, 50937

  • Universitatsklinikum Carl Gustav Carus

    Dresden, 01307

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225

  • Urologische Gemeinschaftspraxis

    Emmendingen, 79312

  • Universitaetsklinikum Hamburg-Eppendorf (UKE)

    Hamburg, 20246

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • 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 Gesundhehitsunion DGU

    Wuppertal, 42103

Other trials in Germany

United Kingdom11 sites

  • Oxford University Hospitals

    Headington, OC3 7LJ

  • Royal Liverpool Hospital

    Liverpool, L7 8XP

  • London Health Science Center - Victoria Hospital

    London, N6A 4L6

  • Guy's Hospital

    London, SE1 9RT

  • Sarah Cannon Research Institutute - UK

    London, W1G 6AD

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral, CH63 4JY

  • Mount Vernon Cancer Centre

    Northwood, England, HA6 2RN

  • Wexham Park Hospital

    Slough, Berkshire, SL2 4HL

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

  • Musgrove Park Hospital

    Taunton, TA1 5DA

Other trials in United Kingdom

Australia9 sites

  • Peninsula & Southeast Oncology

    Frankston, Victoria, 3199

  • Barwon Health, University Hospital Geelong

    Geelong, Victoria, 3220

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Cabrini Hospital

    Malvern, Victoria, 3144

  • Southside Cancer Care Centre

    Miranda, 2228

  • Orange Health Services

    Orange, 2800

  • Northern Cancer Insitute, St. Leonards

    Saint Leonards, New South Wales, 2065

  • St John of God Hospital, Subiaco

    Subiaco, 6008

  • Riverina Cancer Care Centre

    Wagga Wagga, 2650

Other trials in Australia

France8 sites

  • Centre François Baclesse

    Caen, 14000

  • Centre Georges François Leclerc

    Dijon, 21079

  • Clinique Victor Hugo Centre Jean Bernard

    Le Mans, 72000

  • Hôpital Privé La Louvière

    Lille, 59800

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

    Nancy, 54100

  • Institut Curie

    Paris, 75248

  • Hôpital Privé des Côtes d'Armor

    Plérin, 22190

  • CRLCC Eugene Marquis

    Rennes, 35042

Other trials in France

Italy8 sites

  • Ospedale San Donato, Azienda USLSUDEST

    Arezzo, 52100

  • Ospedale Santa Maria delle Croci

    Faenza, 48018

  • IRCCS Istituto Nazionale dei Tumori (INT)

    Milan, 20133

  • IEO Instituto Europeo di Oncologia

    Milan, 20141

  • University of Modena and Reggio Emilia Medical Oncology

    Modena, 41124

  • Azienda Ospedaliera San Camillo-Forlanini

    Rome, 00152

  • Azienda Opsedaliera S. Maria di Terni

    Terni, 05100

  • Santa Chiara Hospital, Dept Medical Oncology

    Trento, 38122

Other trials in Italy

Belgium6 sites

  • ZNA Middelheim

    Antwerp, 2020

  • Universitair Ziekenhuis Gent

    Ghent, B-9000

  • AZ Groeninge

    Kortrijk, 8500

  • CHU Sart-Tilman

    Liège, 4000

  • Equipe de Recherche Clinique, Département d'Oncologie/Hématologie

    Liège, 4000

  • AZ DELTA

    Roeselare, B-8800

Other trials in Belgium

Israel6 sites

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

    Haifa, 3109601

  • Hadassah University Hospital

    Jerusalem, 71120

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • The Tel Aviv Sourasky Medical Center (Ichilov Hospital)

    Tel Aviv, 64231

Other trials in Israel

Ireland5 sites

  • Cork University Hospital

    Cork, T12 DFK4

  • St. Vincent's University Hospital

    Dublin, D04T6F4

  • St James's Hospital

    Dublin, D08 NHY1

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

    Dublin, Dublin 24

  • Mater Misericordiae University Hospital

    Dublin, Dublin 7

Other trials in Ireland

Canada4 sites

  • Juravinski Cancer Centre Hamilton Health Services

    Hamilton, Ontario, L8V5C2

  • London Health Science Center - Victoria Hospital

    London, Ontario, N6A 4L6

  • The Ottawa Hospital

    Ottawa, Ontario, K1H8L6

  • Princess Margaret Hospital

    Toronto, M5G 2M9

Other trials in Canada

Denmark3 sites

  • Copenhagen University Hospital

    Copenhagen, 2100

  • Herlev Hospital

    Herlev, 2730

  • Vejle Sygehus

    Vejle, 7100

Other trials in Denmark

About this study

Official title: TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

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.

Being tested
Rucaparib
Keywords
CRPC, PARP inhibitor, PARPi, BRCA, ATM, HRD, TRITON, homologous recombination, DNA repair, DNA defect, DNA anomaly, BARD1, BRIP1, CDK12, CHEK2, FANCA, NBN, PALB2, RAD51, RAD51B
Medical subject headings
Mental Retardation, X-Linked, With Or Without Seizures, Arx-Related

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

Study groups in NCT02952534
Study groupRoleWhat they receive
RucaparibExperimentalOral rucaparib (monotherapy)
Receives: Drug: Rucaparib

What is being measured

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

  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.

    Measured: 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)

  1. Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Investigator (INV)

    A supportive efficacy endpoint is confirmed radiographic ORR by INV. 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 of diameters.

    Measured: 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.

  2. Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Central Independent Radiology Review (IRR)

    A secondary efficacy endpoint is DOR by central IRR. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.

    Measured: 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.

  3. Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Investigator

    A secondary efficacy endpoint is DOR as assessed by the investigator. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.

    Measured: 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.

  4. Confirmed PSA Response (≥ 50% Decrease) by Gene as Assessed by Local Laboratory

    A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 50% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 50% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.

    Measured: 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.

  5. Confirmed PSA Response (≥ 90% Decrease) by Gene as Assessed by Local Laboratory

    A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 90% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 90% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.

    Measured: 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.

  6. Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Central Independent Radiology Review (IRR)

    A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by IRR. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression adjudicated by IRR using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.

    Measured: 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.

  7. Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Investigator

    A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by Investigator. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.

    Measured: 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.

  8. Overall Survival (OS) by Gene

    A secondary efficacy endpoint is Overall Survival (OS). OS is defined as the date from first dose of rucaparib to the date of death due to any cause, +1 day.

    Measured: From date of first dose until event, loss to follow-up, withdrawal of consent, or study closure: an overall median of approximately 33.1 months

  9. Clinical Benefit Rate (CBR) by Gene Per Central Independent Radiology Review (IRR)

    A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by IRR. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.

    Measured: 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.

  10. Clinical Benefit Rate (CBR) by Gene Per Investigator

    A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by Investigator. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.

    Measured: 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.

  11. Time to PSA Progression by Gene

    A secondary efficacy endpoint is time to PSA progession. Time to PSA progression is defined as the time from first dose of rucaparib to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline if there was no PSA decline after baseline) in PSA was measured, plus 1 day. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later (unless the PSA progression occurred at the last recorded PSA assessment). If confirmed, the date used for time of PSA progression is the earlier of the 2 PSA dates.

    Measured: 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.

  12. Steady State Trough (Cmin) Level Rucaparib Concentrations

    Trough (Cmin) concentrations of rucaparib are summarized for all patients with at least one PK sample collected. The absolute values of rucaparib plasma concentration at each time point are presented by gene.

    Measured: Participants were assessed at Study Day 29, Day 57, Day 85 and Day 113

Timeline

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

  1. First posted2 Nov 2016 (estimated)
  2. Study start15 Feb 2017
  3. Primary completion18 Jul 2021
  4. Study completion27 Jul 2021

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02952534
Sponsor's protocol ID
CO-338-052
Other IDs
2016-003162-13, 2016
Acronym
TRITON2
Status last verified
Jun 2023
First submitted
24 Oct 2016
Last updated
9 Jun 2023
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 Clovis Oncology.

Publications

  • 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.

    PubMed 37277275

  • 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

  • Green 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.

    PubMed 35397664

  • 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 2 study testing Rucaparib in people with Metastatic Castration Resistant Prostate Cancer, run by pharmaand GmbH at 149 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 5 inclusion and 4 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 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in United States, Spain, Germany, United Kingdom, Australia 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 Jun 2022). 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?

Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR) (time frame: 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.). 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 NCT02952534, which also lists 4 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 9 Jun 2023.

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