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AzTrials

Metastatic Prostate CancerNCT03871816

A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer

An observational study of Metastatic Prostate Cancer, run by Janssen Research & Development, LLC at 338 sites in 25 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 evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis
How many people
14,532 participants
Where
338 sitesin 25 countries
Study dates
22 Apr 2019to 22 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Study population consists of male participants diagnosed with metastatic prostate cancer who will be evaluated for the prevalence for DNA-repair gene defects.

Who may be able to join

  • Diagnosis of metastatic (Stage IV) prostate cancer (PC), confirmed by either biopsy of a metastatic tumor site or history of localized disease supported by metastatic disease on imaging studies (that is [i.e.], clearly noted in hospital/clinical records)
  • Signed Informed consent form (ICF)
  • No condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example [e.g.], compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Willing to provide a saliva, blood, and/or archival tumor tissue sample for genomic analysis
  • No prior poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor (PARPi) for the treatment of prostate cancer
  • No prior DNA-repair gene defect test results from a Janssen sponsored interventional trial

Who cannot join

None listed.

Trial locations and contacts

338 sites in 25 countries.

338 sites in 25 countries

United States93 sites
  • Texas Onc.

    Abilene, Texas, 79606

  • New York Oncology Hematology

    Albany, New York, 12208

  • Texas Oncology-Amarillo

    Amarillo, Texas, 79106

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • Texas Oncology-Austin

    Austin, Texas, 78731

  • Centers for Advanced Urology LLC d b a MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702-1449

  • Central Care Cancer Center

    Bolivar, Missouri, 65613

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Affiliated Oncologists, LLC

    Chicago Ridge, Illinois, 60415

  • Maryland Oncology Hematology, PA

    Columbia, Maryland, 21044

  • Pontchartrain Cancer Center

    Covington, Louisiana, 70433

  • Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • Advanced Urology Institute

    Daytona Beach, Florida, 32114

  • Texas Oncology-Denton South

    Denton, Texas, 76201

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • INOVA

    Fairfax, Virginia, 22031

  • Texas Oncology, P.A. - Flower Mound

    Flower Mound, Texas, 75028

  • Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

    Fort Lauderdale, Florida, 33308-4668

  • Fort Wayne Medical Oncology and Hematology, Inc.

    Fort Wayne, Indiana, 46804

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Frederick Health Hospital - James M Stockman Cancer Institute

    Frederick, Maryland, 21702-4337

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Foothills Urology - Golden Off

    Golden, Colorado, 80401

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Prisma Health

    Greenville, South Carolina, 29615

  • Urology Centers Of Alabama

    Homewood, Alabama, 35209

  • Hawaii Cancer Care

    Honolulu, Hawaii, 96813

  • Consultants in Medical Oncology and Hematology, P.C. - Abington

    Horsham, Pennsylvania, 19044

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • Houston Metro Urology

    Houston, Texas, 77027

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Texas Oncology - Willowbrook

    Houston, Texas, 77070

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Building Oncology Research

    Janesville, Wisconsin, 53548

  • First Urology

    Jeffersonville, Indiana, 47130

  • Lancaster Urology

    Lancaster, Pennsylvania, 17601

  • Edward W Sparrow Hospital

    Lansing, Michigan, 48219

  • Virginia Cancer Specialists

    Leesburg, Virginia, 20176

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • MemorialCare Research Miller Children's and Women's Hospital Long Beach

    Long Beach, California, 90806

  • Texas Oncology P.A.

    Longview, Texas, 75601

  • Norton Healthcare

    Louisville, Kentucky, 40202

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Texas Oncology P.A.

    McAllen, Texas, 78503

  • Texas Oncology-Mesquite

    Mesquite, Texas, 75150

  • Miami Cancer Institute at Baptist Health / Baptist Health Medical Group

    Miami, Florida, 33176

  • Texas Oncology-Midland Allison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Southern Cancer Center, PC

    Mobile, Alabama, 36608

  • Atlantic Urology Clinics

    Myrtle Beach, South Carolina, 29572

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Tisch Cancer Institution

    New York, New York, 10029

  • Virginia Oncology Asc

    Norfolk, Virginia, 23502

  • Eastern Connecticut Hematology & Oncology Assoc.

    Norwich, Connecticut, 06360

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Adult Pediatric Urology & Urogynecology, P.C

    Omaha, Nebraska, 68114

  • GU Research Network

    Omaha, Nebraska, 68130

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Texas Oncology, P.A. - Paris

    Paris, Texas, 75460

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85016

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15232

  • Texas Oncology P A

    Plano, Texas, 75075

  • Texas Oncology P.A.

    Plano, Texas, 75093

  • Beth Israel Deaconess Hospital Plymouth, Jordan Club Cancer Center

    Plymouth, Massachusetts, 02360

  • Northwest Cancer Specialists PC

    Portland, Oregon, 97213-2982

  • Kaiser Permanente

    Riverside, California, 92505

  • Mosaic Life Care

    Saint Joseph, Missouri, 64507

  • Oregon Oncology Specialists

    Salem, Oregon, 97301

  • University of Texas at San Antonio

    San Antonio, Texas, 78217

  • San Bernardino Urological Associates

    San Bernardino, California, 92506

  • Sansum Clinic Pharm

    Santa Barbara, California, 93105

  • Beacon Medical Group Clinical Research

    South Bend, Indiana, 46601

  • Oregon Urology Institute

    Springfield, Oregon, 97477

  • Associated Medical Professionals

    Syracuse, New York, 13210

  • Upstate Cancer Center

    Syracuse, New York, 13210

  • Northwest Medical Specialists

    Tacoma, Washington, 98405

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Chesapeake Urology Associates

    Towson, Maryland, 21204

  • Michigan Institute of Urology

    Troy, Michigan, 48084

  • Urological Associates of Southern Arizona, P.C.

    Tucson, Arizona, 85741

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74146

  • Urology of Virginia, PLCC

    Virginia Beach, Virginia, 23462

  • Texas Oncology -Waco

    Waco, Texas, 76712

  • Texas Oncology Deke Slayton Cancer Center

    Webster, Texas, 77598

  • Texas Oncology P.A.

    Wichita Falls, Texas, 76310

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

Other trials in United States

Brazil34 sites
  • Fundacao Pio XII

    Barretos, 14784-400

  • Cetus Oncologia

    Belo Horizonte, 30110-022

  • PERSONAL - Oncologia de Precisão e Personalizada

    Belo Horizonte, 30130-090

  • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia

    Brasília, 7020-730

  • CIONC - Centro Integrado de Oncologia de Curitiba

    Curitiba, 80810-050

  • Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060

  • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN

    Florianópolis, 88034-000

  • Suporte Nutricional e Quimioterapia Ltda-Pronutrir

    Fortaleza, 60 810180

  • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

    Goiânia, 74605-070

  • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

    Ijuí, 98700-000

  • Fundação São Francisco Xavier

    Ipatinga, 35162 189

  • Clínica de Neoplasias Litoral Ltda.

    Itajaí, 88301-220

  • Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia

    Joinville, 89201-260

  • Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.

    Maceió, 57052-765

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062-000

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090

  • Hospital Ernesto Dornelles

    Porto Alegre, 90160-093

  • MultiHemo Servicos Medicos S.A

    Recife, CEP: 50070-460

  • Universidade do Estado do Rio de Janeiro - UERJ

    Rio de Janeiro, 20551-030

  • Oncoclínicas Rio de Janeiro S.A.

    Rio de Janeiro, 22250-905

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775-001

  • Nucleo de Oncologia da Bahia

    Salvador, 40170-110

  • Hospital Sao Rafael

    Salvador, 41253-190

  • CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060-650

  • Instituto do Cancer Arnaldo Vieira de Carvalho

    São Paulo, 01221-020

  • Irmandade Santa Casa de Misericordia de Sao Paulo

    São Paulo, 01221-020

  • Instituto de Ensino e Pesquisa São Lucas

    São Paulo, 01236-030

  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246-000

  • Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, 01323-900

  • Fundacao Antonio Prudente - A.C. Camargo Cancer Center

    São Paulo, 01509900

  • Núcleo de Pesquisa São Camilo

    São Paulo, 04014-002

  • Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

    São Paulo, 04039-004

  • IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

    Sorocaba, 18030-075

  • Instituto do Cancer De Tres Lagoas

    Três Lagoas, 79601-001

Other trials in Brazil

Spain25 sites
  • Hosp. Univ. A Coruna

    A Coruña, 15006

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hosp. Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Gral. Univ. de Castellon

    Castellon, 12004

  • Institut Català D'Oncologia Girona

    Girona, 17007

  • Hosp. Univ. de Jaen

    Jaén, 23007

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Hosp. Univ. Arnau de Vilanova de Lleida

    Lleida, 25198

  • Hosp. Univ. de La Princesa

    Madrid, 28006

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. Univ. Hm Monteprincipe

    Madrid, 28660

  • Hosp. Univ. Del Henares

    Madrid, 28822

  • Hosp. Virgen de La Victoria

    Málaga, 29010

  • Complexo Hosp. Univ. de Ourense

    Ourense, 32005

  • Hosp. Univ. Infanta Cristina

    Parla, Madrid, 28981

  • Hosp. Puerto Real

    Puerto Real, Cádiz, 11510

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. de Sant Pau I Santa Tecla

    Tarragona, 43003

  • Hosp. de Terrassa

    Terrassa, 08227

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

Other trials in Spain

France17 sites
  • Institut Sainte Catherine

    Avignon, 84918

  • Centre Hospitalier Regional Universitaire Besancon

    Besançon, 25030

  • Institut Bergonié

    Bordeaux, 33000

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Bérard

    Lyon, 69008

  • Polyclinique de Gentilly

    Nancy, 54100

  • Centre Antoine Lacassagne

    Nice, 6189

  • Hopital Europeen Georges-Pompidou

    Paris, 75908

  • Institut de Cancérologie de l'Ouest (ICO)

    Saint-Herblain, 44805

  • HIA Begin

    Saint-Mandé, 94163

  • Institut de Cancérologie de Loire

    Saint-Priest-en-Jarez, 42271

  • Clinique Sainte Anne

    Strasbourg, 67000

  • Hôpitaux Universitaire de Strasbourg -CHU

    Strasbourg, 67091

  • Hopital Foch

    Suresnes, 32151

  • CHRU de Tours

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Argentina15 sites
  • Hospital Aleman

    Buenos Aires, C1118AAT

  • Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

    Buenos Aires, C1419AHN

  • Centro Oncológico Korben

    Buenos Aires, C1426AGE

  • CEMIC Saavedra

    Buenos Aires, C1431FWN

  • CINME - Centro de Investigaciones Metabolicas

    Caba, C1027AAP

  • Centro de Urologia (CDU)

    Ciudad Automoma Buenos Aires, C1120AAT

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de, C1199ABB

  • Clínica Adventista Belgrano

    Ciudad de Buenos Aires, C1430EGF

  • Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, 5000

  • Centro Urologico Profesor Bengio

    Córdoba, X5000KPH

  • Hospital Privado - Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Hospital Privado de Comunidad

    Mar del Plata, B7602CBM

  • Centro de Investigacion Pergamino SA

    Pergamino, B2700CPM

  • Sanatorio Parque

    Rosario, S2000SDV

  • ARS Médica

    San Salvador de Jujuy, Y4600AFW

Other trials in Argentina

Italy15 sites
  • Ospedale Cardinal Massaia

    Asti, 14100

  • Ospedale Sacro Cuore Di Gesu

    Benevento, 82100

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Ospedale di Bolzano

    Bolzano, 39100

  • oncologia medica - Oncology

    Brindisi, 72100

  • Azienda Ulss 6 Euganea- Ospedale Di Camposampiero

    Camposampiero, 35012

  • Ospedale Di Carrara

    Carrara, 54033

  • AORN Sant'anna e San Sebastiano

    Caserta, 81100

  • ASST -Ospedale Maggiore di Crema

    Crema, 26013

  • Azienda ULSS 3 Serenissima, presidio di Mirano

    Mirano, 30035

  • PP.OO. di Piombino e Portoferraio Azienda USL Toscana nord ovest

    Piombino, 57025

  • Ospedale degli Infermi

    Ponderano, 13875

  • Ospedale del Mare ASL Napoli 1 centro

    Ponticelli, 80147

  • Azienda ULSS5 Polesana di Rovigo - Ospedale Santa Maria della Misericordia

    Rovigo, 45100

  • PO Ospedale S.Anna, ASST Lariana

    San Fermo della Battaglia, 22042

Other trials in Italy

Ukraine15 sites
  • Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

    Cherkasy, 18009

  • Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc

    Dnipo, 49005

  • Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

    Dnipro, 49100

  • Ivano-Frankivsk Regional Clinical Hospital

    Ivano-Frankivsk, 76008

  • Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council

    Kamyanske, 51900

  • Municipal non-profit enterprise 'Regional Center of Oncology'

    Khakhiv, 61070

  • Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval

    Kharkiv, 61037

  • Khmelnitckiy regional hospital

    Khmelnytsky, 29000

  • Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'

    Kropyvnytskyi, 25011

  • National Cancer Institute

    Kyiv, 03022

  • State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

    Kyiv, 03115

  • Lviv Clinical Regional Hospital

    Lviv, 79031

  • ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'

    Poltava, 36024

  • Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

    Uzhhorod, 88000

  • Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council

    Zhytomyr, 10002

Other trials in Ukraine

South Korea14 sites
  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • Chungnam National University Hospital

    Daejeon, 35015

  • National Cancer Center

    Goyang-si, 10408

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Ajou University Hospital

    Gyeonggi-do, 16499

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, 06591

Other trials in South Korea

Australia13 sites
  • Pindara Private Hospital

    Benowa, 4217

  • Sunshine Coast University Hospital

    Birtinya, 4575

  • Chris O'Brien Lifehouse

    Camperdown, 2050

  • St Vincent's hospital

    Darlinghurst, 2010

  • Border Medical Oncology

    East Albury, 2640

  • Royal Hobart Hospital

    Hobart, 7000

  • Ashford Cancer Centre

    Kurralta Park, 5037

  • Liverpool Hospital

    Liverpool, 2170

  • Macquarie University Hospital

    Macquarie University, 2109

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Prince Of Wales Hospital

    Randwick, 2031

  • Sydney Adventist Hospital

    Wahroonga, 2076

Other trials in Australia

Russia13 sites
  • Altai Regional Oncology Dispensary

    Barnaul, 656045

  • Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

    Chelyabinsk, 454087

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • Russian Scientific Center of Roentgenoradiology

    Moscow, 117997

  • Moscow City Clinical Hospital # 62

    Moscow, 125130

  • Hertzen Oncology Research Institute

    Moscow, 125284

  • Privolzhsky District Medical Centre

    Nizhny Novgorod, 603074

  • Clinical Oncology Dispensary

    Omsk, 644013

  • Pyatigorsk Interdistrict Oncology Dispensary

    Pyatigorsk, 357502

  • Leningrad Regional Oncology Dispensary

    Saint Petersburg, 191104

  • Republican Oncology Dispensary

    Saransk, 430032

  • Multifunctional clinical medical center 'Medical city'

    Tyumen, 625041

  • Bashkir State Medical University

    Ufa, 450008

Other trials in Russia

Turkey (Türkiye)11 sites
  • Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Ankara Bilkent City Hospital

    Ankara, 06800

  • Akdeniz University Medical Faculty

    Antalya, 07070

  • Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi

    Bursa, 16310

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34000

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

    Istanbul, 34098

  • T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

    Istanbul, 34722

  • Izmir Medical Park Hospital

    Izmir, 35580

  • Sakarya University Training and Research Hospital

    Sakarya, 54100

Other trials in Turkey (Türkiye)

Taiwan10 sites
  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 88301

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Tungs' Taichung MetroHarbor Hospital

    Taichung, 435

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Chi Mei Medical Center - Yong Kang

    Tainan, 710

  • National Taiwan University Hospital

    Taipei, 10002

  • Tri-Service General Hospital

    Taipei, 11490

  • Chang Gung Memorial Hospital

    Taoyuan, 33305

Other trials in Taiwan

Poland9 sites
  • Centrum Onkologii im. Prof. F. Lukaszczyka

    Bydgoszcz, 85-796

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia, 81-519

  • Przychodnia Lekarska KOMED Roman Karaszewski

    Konin, 62-500

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    Lodz, 93-513

  • Urologica Praktyka Lekarska Adam Marcheluk

    Siedlce, 08-110

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

  • Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

    Warsaw, 04-073

  • Specjalistyczna przychodnia lekarska POLIMED

    Wroclaw, 53-329

Other trials in Poland

Belarus8 sites
  • Bobruisk Interregional Oncological Dispensary

    Babruysk, 213825

  • Brest Regional Oncology Dispensary

    Brest, 224027

  • Grodno University Hospital

    Grodno, 230017

  • Gomel Regional Clinical Oncology Dispensary

    Homyel, 246012

  • State Institution N.N. Alexandrov Republican Scientific and

    Lesnoy, 223040

  • Minsk city Clinical Oncological Dispensary

    Minsk, 220013

  • Mogilev Regional Hospital

    Mogilev, 212018

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210603

Other trials in Belarus

Canada8 sites
  • Southern Alberta Institute of Urology / Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9

  • McMaster Institute of Urology

    Hamilton, Ontario, L8N 4A6

  • Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)

    Kingston, Ontario, K7L 3N6

  • Centre de Recherche du CHUM

    Montreal, Quebec, H2X 0A9

  • Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc

    Québec, Quebec, G1R2J6

  • University Health Network (UHN) Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency (BCCA) - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

  • British Columbia Cancer Agency - Vancouver Island Centre

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Germany8 sites
  • Urologisches Zentrum Bonn

    Bonn, 53111

  • Urologie im Schlosscarree Schreier/Eichler/Junius - Germany

    Braunschweig, 38100

  • Zeisigwaldkliniken Bethanien Chemnitz

    Chemnitz, 09130

  • Urologische Gemeinschaftspraxis Böhm/Linne - Germany

    Dresden, 01307

  • uro Eimsbüttel - Gemeinschaftspraxis Bath/Weinzierl

    Hamburg, 20255

  • Klinikum Region Hannover Klinikum Siloah

    Hanover, 30459

  • Matthias Schulze - Germany

    Markkleeberg, 04416

  • CUROS - Uberörtliche urologische Gemeinschaftspraxis

    Wesseling, 50389

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Israel5 sites
  • Soroka Hospital

    Beersheba, 85101

  • Rambam Hospital

    Haifa, 31096

  • Rabin Medical Center

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, 74047

  • Asaf Harofe Medical Center

    Zrifin, 60930

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Belgium4 sites
  • Clinique Notre Dame de Grâce

    Charleroi, 6000

  • Jolimont

    Haine-Saint-Paul, La Louviere, 7100

  • Clinique Saint Pierre

    Ottignies, 1340

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

Other trials in Belgium

Bulgaria4 sites
  • MHAT Deva Maria

    Burgas, 8001

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

  • District Oncology Dispensary with In-Patient Stationary - Plovdiv

    Plovdiv, 4004

  • Comprehensive Cancer Center

    Vratsa, 3001

Other trials in Bulgaria

Malaysia4 sites
  • Hospital Pulau Pinang

    George Town, 10990

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Sarawak General Hospital

    Kuching, 93586

Other trials in Malaysia

Netherlands3 sites
  • Renier de Graaf

    Delft, 2625 AD

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6524 KD

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, 5022 GC

Other trials in Netherlands

Thailand3 sites
  • Ramathibodi Hospital

    Bangkok, 10400

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10500

  • Siriraj Hospital

    Bangkok, 10700

Other trials in Thailand

United Kingdom3 sites
  • Royal Blackburn Hospital

    Blackburn, BB2 3HH

  • Royal Marsden Hospital

    London, SW7 3RP

  • University College London Hospitals

    London, WC1E 6BT

Other trials in United Kingdom

Denmark2 sites
  • Copenhagen University Hospital

    Copenhagen, 2100

  • Næstved Hospital

    Næstved, 4700

Other trials in Denmark

Sweden2 sites
  • Skanes universitetssjukhus

    Malmö, 20502

  • Södersjukhuset

    Stockholm, 11883

Other trials in Sweden

About this study

Official title: Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer

The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies.

Being tested
Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Saliva, Blood, or and/or Archival Tumor Tissue Collection and AnalysisOther

    Saliva, blood, and/or archival tumor tissue will be collected from the participants with metastatic PC for genomic testing to confirm DRD status.

Study groups in NCT03871816
Study groupRoleWhat they receive
Participants with Metastatic Prostate CancerParticipants with metastatic prostate Cancer (PC) will be evaluated for the prevalence of DNA-repair gene defects (DRDs) and will be assessed for biomarker eligibility status for niraparib interventional studies. Participants will be consented to saliva, blood, and/or archival tumor tissue testing for the presence or absence of DNA-repair gene defects.
Receives: Other: Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis

What is being measured

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

  1. Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Prostate Cancer as an Estimate for Prevalence

    Percentage of participants with 4 or more Deoxyribonucleic acid (DNA)-repair gene defects with metastatic Prostate Cancer (PC) as an estimate for prevalence will be assessed. A saliva, blood, and/or archival tumor tissue sample will be collected for genomic testing to confirm DNA-repair gene defect (DRD) status.

    Measured: Approximately 2.4 years

  2. Percentage of Participants who Meet Biomarker Eligibility Criteria for Other Niraparib Interventional Studies

    Percentage of participants who meet biomarker eligibility criteria for other niraparib interventional studies will be assessed.

    Measured: Approximately 2.4 years

Secondary outcomes (2)
  1. Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and with Metastatic Hormone Sensitive PC (HSPC) as an Estimate for Prevalence

    Percentage of participants with 4 or more DRDs with mCRPC and HSPC as an estimate for prevalence will be assessed. A saliva, blood, and/or archival tumor tissue sample will be collected for genomic testing to confirm DRD status.

    Measured: Approximately 2.4 years

  2. Percentage of Participants with 1 or more DNA-repair gene defects with Metastatic Prostate Cancer as an Estimate for Prevalence

    Percentage of participants with 1 or more DRDs with metastatic PC as an estimate for prevalence will be assessed. Saliva, blood, and/or archival tumor tissue sample will be collected for genomic testing to confirm DRD status.

    Measured: Approximately 2.4 years

Timeline

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

  1. First posted12 Mar 2019
  2. Study start22 Apr 2019
  3. Primary completion30 Oct 2022
  4. Study completion22 Nov 2022

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
14,532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03871816
Sponsor's protocol ID
CR108591
Other IDs
64091742PCR0002
Status last verified
Dec 2023
First submitted
11 Mar 2019
Last updated
11 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Prostate Cancer, run by Janssen Research & Development, LLC at 338 sites in 25 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 0 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 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 338 sites in United States, Brazil, Spain, France, Argentina and 20 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Prostate Cancer as an Estimate for Prevalence (time frame: Approximately 2.4 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?
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 11 Dec 2023.

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