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

December 8, 2023 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14532

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Hospital Aleman
      • Buenos Aires, Argentina, C1419AHN
        • Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
      • Buenos Aires, Argentina, C1426AGE
        • Centro Oncologico Korben
      • Caba, Argentina, C1027AAP
        • Cinme - Centro de Investigaciones Metabolicas
      • Ciudad Automoma Buenos Aires, Argentina, C1120AAT
        • Centro de Urologia (CDU)
      • Ciudad Autonoma de, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Argentina, C1431FWN
        • CEMIC Saavedra
      • Ciudad De Buenos Aires, Argentina, C1430EGF
        • Clinica Adventista Belgrano
      • Cordoba, Argentina, X5016KEH
        • Hospital Privado - Centro Medico de Cordoba
      • Cordoba, Argentina, 5000
        • Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
      • Cordoba, Argentina, X5000KPH
        • Centro Urológico Profesor Bengió
      • Mar Del Plata, Argentina, B7602CBM
        • Hospital Privado de Comunidad
      • Pergamino, Argentina, B2700CPM
        • Centro de Investigacion Pergamino SA
      • Rosario, Argentina, S2000SDV
        • Sanatorio Parque
      • San Salvador De Jujuy, Argentina, Y4600AFW
        • ARS Medica
  • Australia
      • Benowa, Australia, 4217
        • Pindara Private Hospital
      • Birtinya, Australia, 4575
        • Sunshine Coast University Hospital
      • Camperdown, Australia, 2050
        • Chris O'Brien Lifehouse
      • Darlinghurst, Australia, 2010
        • St Vincent's Hospital
      • East Albury, Australia, 2640
        • Border Medical Oncology
      • Hobart, Australia, 7000
        • Royal Hobart Hospital
      • Kurralta Park, Australia, 5037
        • Ashford Cancer Centre
      • Liverpool, Australia, 2170
        • Liverpool Hospital
      • Macquarie University, Australia, 2109
        • Macquarie University Hospital
      • Melbourne, Australia, 3000
        • Peter MacCallum Cancer Centre
      • Murdoch, Australia, 6150
        • Fiona Stanley Hospital
      • Randwick, Australia, 2031
        • Prince of Wales Hospital
      • Wahroonga, Australia, 2076
        • Sydney Adventist Hospital
  • Belarus
      • Bobruisk, Belarus, 213825
        • Bobruisk Interregional Oncological Dispensary
      • Brest, Belarus, 224027
        • Brest Regional Oncology Dispensary
      • Gomel, Belarus, 246012
        • Gomel Regional Clinical Oncology Dispensary
      • Grodno, Belarus, 230017
        • Grodno University Hospital
      • Lesnoy, Belarus, 223040
        • State Institution N.N. Alexandrov Republican Scientific and
      • Minsk, Belarus, 220013
        • Minsk city Clinical Oncological Dispensary
      • Mogilev, Belarus, 212018
        • Mogilev Regional Hospital
      • Vitebsk, Belarus, 210603
        • Vitebsk Regional Clinical Hospital
  • Belgium
      • Charleroi, Belgium, 6000
        • Clinique Notre Dame de Grâce
      • Haine-Saint-Paul, La Louviere, Belgium, 7100
        • Jolimont
      • Ottignies, Belgium, 1340
        • Clinique Saint Pierre
      • Roeselare, Belgium, 8800
        • Algemeen Ziekenhuis Delta
  • Brazil
      • Barretos, Brazil, 14784-400
        • Fundação PIO XII
      • Belo Horizonte, Brazil, 30130-090
        • PERSONAL - Oncologia de Precisao e Personalizada
      • Belo Horizonte, Brazil, 30110-022
        • Cetus Oncologia
      • Brasilia, Brazil, 7020-730
        • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
      • Curitiba, Brazil, 80810-050
        • CIONC - Centro Integrado de Oncologia de Curitiba
      • Curitiba, Brazil, 81520-060
        • Liga Paranaense de Combate ao Cancer
      • Florianopolis, Brazil, 88034-000
        • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
      • Fortaleza, Brazil, 60 810180
        • Suporte Nutricional e Quimioterapia Ltda-Pronutrir
      • Goiania, Brazil, 74605-070
        • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
      • Ijui, Brazil, 98700-000
        • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
      • Ipatinga, Brazil, 35162 189
        • Fundação São Francisco Xavier
      • Itajai, Brazil, 88301-220
        • Clínica de Neoplasias Litoral Ltda.
      • Joinville, Brazil, 89201-260
        • Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia
      • Maceio, Brazil, 57052-765
        • Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.
      • Natal, Brazil, 59062-000
        • Liga Norte Riograndense Contra O Câncer
      • Porto Alegre, Brazil, 90020-090
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre, Brazil, 90160-093
        • Hospital Ernesto Dornelles
      • Recife, Brazil, CEP: 50070-460
        • MultiHemo Servicos Medicos S.A
      • Rio de Janeiro, Brazil, 22250-905
        • Oncoclinicas Rio de Janeiro S.A.
      • Rio de Janeiro, Brazil, 22775-001
        • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
      • Rio de Janeiro, Brazil, 20551-030
        • Universidade do Estado do Rio de Janeiro - UERJ
      • Salvador, Brazil, 41253-190
        • Hospital Sao Rafael
      • Salvador, Brazil, 40170-110
        • Nucleo de Oncologia da Bahia
      • Santo André, Brazil, 09060-650
        • CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
      • Sao Paulo, Brazil, 01246-000
        • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
      • Sao Paulo, Brazil, 01509900
        • Fundacao Antonio Prudente - A.C. Camargo Cancer Center
      • Sao Paulo, Brazil, 01236-030
        • Instituto de Ensino e Pesquisa São Lucas
      • Sao Paulo, Brazil, 01221-020
        • Irmandade Santa Casa de Misericordia de Sao Paulo
      • Sao Paulo, Brazil, 04039-004
        • Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
      • Sorocaba, Brazil, 18030-075
        • IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
      • São Paulo, Brazil, 01323-900
        • Real e Benemérita Associação Portuguesa de Beneficência
      • São Paulo, Brazil, 04014-002
        • Núcleo de Pesquisa São Camilo
      • São Paulo, Brazil, 01221-020
        • Instituto do Cancer Arnaldo Vieira de Carvalho
      • Tres Lagoas, Brazil, 79601-001
        • Instituto do Cancer De Tres Lagoas
  • Bulgaria
      • Burgas, Bulgaria, 8001
        • MHAT Deva Maria
      • Pleven, Bulgaria, 5800
        • UMHAT 'Dr. Georgi Stranski', EAD
      • Plovdiv, Bulgaria, 4004
        • District Oncology Dispensary with In-Patient Stationary - Plovdiv
      • Vratsa, Bulgaria, 3001
        • Comprehensive Cancer Center
  • Canada
      • Quebec, Canada, G1R2J6
        • Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc
    • Alberta
      • Calgary, Alberta, Canada, T2V 1P9
        • Southern Alberta Institute of Urology / Prostate Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency (BCCA) - Vancouver Centre
      • Victoria, British Columbia, Canada, V8R 6V5
        • British Columbia Cancer Agency - Vancouver Island Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • McMaster Institute of Urology
      • Kingston, Ontario, Canada, K7L 3N6
        • Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network (UHN) Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre de Recherche du CHUM
  • Denmark
      • Copenhagen, Denmark, 2100
        • Copenhagen University Hospital
      • Naestved, Denmark, 4700
        • Næstved Hospital
  • France
      • Avignon, France, 84918
        • Institut Sainte Catherine
      • Besançon, France, 25030
        • Centre Hospitalier Regional Universitaire Besancon
      • Bordeaux, France, 33000
        • Institut Bergonié
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Nancy, France, 54100
        • Polyclinique de Gentilly
      • Nice, France, 6189
        • Centre Antoine Lacassagne
      • Paris Cedex 15, France, 75908
        • Hopital Europeen Georges-Pompidou
      • Saint Herblain, France, 44805
        • Institut de cancerologie de l'ouest (ICO)
      • Saint Mande, France, 94163
        • Hia Begin
      • Saint-Priest-en-Jarez, France, 42271
        • Institut de Cancérologie de Loire
      • Strasbourg, France, 67000
        • Clinique Sainte Anne
      • Strasbourg, France, 67091
        • Hôpitaux Universitaire de Strasbourg -CHU
      • Suresnes, France, 32151
        • Hopital FOCH
      • Tours, France, 37044
        • CHRU de Tours
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Bonn, Germany, 53111
        • Urologisches Zentrum Bonn
      • Braunschweig, Germany, 38100
        • Urologie im Schlosscarree Schreier/Eichler/Junius - Germany
      • Chemnitz, Germany, 09130
        • Zeisigwaldkliniken Bethanien Chemnitz
      • Dresden, Germany, 01307
        • Urologische Gemeinschaftspraxis Böhm/Linne - Germany
      • Hamburg, Germany, 20255
        • uro Eimsbüttel - Gemeinschaftspraxis Bath/Weinzierl
      • Hannover, Germany, 30459
        • Klinikum Region Hannover Klinikum Siloah
      • Markkleeberg, Germany, 04416
        • Matthias Schulze - Germany
      • Wesseling, Germany, 50389
        • CUROS - Uberörtliche urologische Gemeinschaftspraxis
  • Israel
      • Beer-Sheva, Israel, 85101
        • Soroka Hospital
      • Haifa, Israel, 31096
        • Rambam Hospital
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center
      • Ramat Gan, Israel, 74047
        • Sheba Medical Center
      • Zrifin, Israel, 60930
        • Asaf Harofe Medical Center
  • Italy
      • Asti, Italy, 14100
        • Ospedale Cardinal Massaia
      • Benevento, Italy, 82100
        • Ospedale Sacro Cuore Di Gesu
      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Bolzano, Italy, 39100
        • Ospedale di Bolzano
      • Brindisi, Italy, 72100
        • oncologia medica - Oncology
      • Camposampiero, Italy, 35012
        • Azienda Ulss 6 Euganea- Ospedale Di Camposampiero
      • Carrara, Italy, 54033
        • Ospedale Di Carrara
      • Caserta, Italy, 81100
        • AORN Sant'Anna e San Sebastiano
      • Crema, Italy, 26013
        • ASST -Ospedale Maggiore di Crema
      • Mirano, Italy, 30035
        • Azienda ULSS 3 Serenissima, presidio di Mirano
      • Piombino, Italy, 57025
        • PP.OO. di Piombino e Portoferraio Azienda USL Toscana nord ovest
      • Ponderano, Italy, 13875
        • Ospedale degli Infermi
      • Ponticelli, Italy, 80147
        • Ospedale del Mare ASL Napoli 1 centro
      • Rovigo, Italy, 45100
        • Azienda ULSS5 Polesana di Rovigo - Ospedale Santa Maria della Misericordia
      • San Fermo della Battaglia, Italy, 22042
        • PO Ospedale S.Anna, ASST Lariana
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
      • Daegu, Korea, Republic of, 42601
        • Keimyung University Dongsan Hospital
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Goyang-Si, Korea, Republic of, 10408
        • National Cancer Center
      • Gwangju, Korea, Republic of, 61469
        • Chonnam National University Hospital
      • Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea Seoul St. Mary'S Hospital
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
  • Malaysia
      • George Town, Malaysia, 10990
        • Hospital Pulau Pinang
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
      • Kuching, Malaysia, 93586
        • Sarawak General Hospital
  • Netherlands
      • Delft, Netherlands, 2625 AD
        • Renier de Graaf
      • Nijmegen, Netherlands, 6524 KD
        • Canisius-Wilhelmina Ziekenhuis
      • Tilburg, Netherlands, 5022 GC
        • Elisabeth-TweeSteden Ziekenhuis
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Centrum Onkologii im. Prof. F. Lukaszczyka
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Gdynia, Poland, 81-519
        • Szpitale Pomorskie Sp. z o.o.
      • Konin, Poland, 62-500
        • Przychodnia Lekarska KOMED Roman Karaszewski
      • Lodz, Poland, 93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
      • Siedlce, Poland, 08-110
        • Urologica Praktyka Lekarska Adam Marcheluk
      • Warszawa, Poland, 04-073
        • Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
      • Warszawa, Poland, 02-781
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
      • Wroclaw, Poland, 53-329
        • Specjalistyczna przychodnia lekarska POLIMED
  • Russian Federation
      • Barnaul, Russian Federation, 656045
        • Altai Regional Oncology Dispensary
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
      • Ivanovo, Russian Federation, 153040
        • Ivanovo Regional Oncology Dispensary
      • Moscow, Russian Federation, 125130
        • Moscow City Clinical Hospital # 62
      • Moscow, Russian Federation, 125284
        • Hertzen Oncology Research Institute
      • Moscow, Russian Federation, 117997
        • Russian Scientific Center of Roentgenoradiology
      • Nizhny Novgorod, Russian Federation, 603074
        • Privolzhsky District Medical Centre
      • Omsk, Russian Federation, 644013
        • Clinical Oncology Dispensary
      • Pyatigorsk, Russian Federation, 357502
        • Pyatigorsk Interdistrict Oncology Dispensary
      • Saint-Petersburg, Russian Federation, 191104
        • Leningrad Regional Oncology Dispensary
      • Saransk, Russian Federation, 430032
        • Republican Oncology Dispensary
      • Tyumen, Russian Federation, 625041
        • Multifunctional clinical medical center 'Medical city'
      • Ufa, Russian Federation, 450008
        • Bashkir State Medical University
  • Spain
      • A Coruña, Spain, 15006
        • Hosp. Univ. A Coruna
      • Barcelona, Spain, 08025
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona, Spain, 08036
        • Hosp. Clinic de Barcelona
      • Castellon, Spain, 12004
        • Hosp. Gral. Univ. de Castellon
      • Girona, Spain, 17007
        • Institut Catala d'Oncologia Girona
      • Jaén, Spain, 23007
        • Hosp. Univ. de Jaen
      • Jerez de la Frontera, Spain, 11407
        • Hosp. de Jerez de La Frontera
      • Lleida, Spain, 25198
        • Hosp. Univ. Arnau de Vilanova de Lleida
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Spain, 28046
        • Hosp. Univ. La Paz
      • Madrid, Spain, 28031
        • Hosp. Univ. Infanta Leonor
      • Madrid, Spain, 28006
        • Hosp. Univ. de La Princesa
      • Madrid, Spain, 28660
        • Hosp. Univ. Hm Monteprincipe
      • Madrid, Spain, 28822
        • Hosp. Univ. Del Henares
      • Málaga, Spain, 29010
        • Hosp. Virgen de La Victoria
      • Ourense, Spain, 32005
        • Complexo Hosp. Univ. de Ourense
      • Parla, Madrid, Spain, 28981
        • Hosp. Univ. Infanta Cristina
      • Puerto Real, Cádiz, Spain, 11510
        • Hosp. Puerto Real
      • Sabadell, Spain, 08208
        • Corporacio Sanitari Parc Tauli
      • Santander, Spain, 39008
        • Hosp. Univ. Marques de Valdecilla
      • Sevilla, Spain, 41013
        • Hosp. Virgen Del Rocio
      • Tarragona, Spain, 43003
        • Hosp. de Sant Pau I Santa Tecla
      • Terrassa, Spain, 08227
        • Hosp. de Terrassa
      • Valencia, Spain, 46010
        • Hosp. Clinico Univ. de Valencia
  • Sweden
      • Malmö, Sweden, 20502
        • Skanes universitetssjukhus
      • Stockholm, Sweden, 11883
        • Södersjukhuset
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan, 88301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 435
        • Tungs' Taichung MetroHarbor Hospital
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Tainan, Taiwan, 710
        • Chi Mei Medical Center - Yong Kang
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taoyuan, Taiwan, 33305
        • Chang Gung Memorial Hospital
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Bangkok, Thailand, 10500
        • King Chulalongkorn Memorial Hospital
  • Turkey
      • Ankara, Turkey, 06520
        • Memorial Ankara Hastanesi
      • Ankara, Turkey, 06200
        • Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
      • Ankara, Turkey, 06800
        • Ankara Bilkent City Hospital
      • Antalya, Turkey, 07070
        • Akdeniz University Medical Faculty
      • Bursa, Turkey, 16310
        • Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi
      • Edirne, Turkey, 22030
        • Trakya University Medical Faculty
      • Istanbul, Turkey, 34098
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
      • Istanbul, Turkey, 34722
        • T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi
      • Istanbul, Turkey, 34000
        • Istanbul University Istanbul Medical Faculty
      • Izmir, Turkey, 35580
        • Izmir Medical Park Hospital
      • Sakarya, Turkey, 54100
        • Sakarya University Training and Research Hospital
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
      • Dnipo, Ukraine, 49005
        • Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
      • Dnipro, Ukraine, 49100
        • Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
      • Ivano-Frankivsk, Ukraine, 76008
        • Ivano-Frankivsk Regional Clinical Hospital
      • Kamianske, Ukraine, 51900
        • Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
      • Khakhiv, Ukraine, 61070
        • Municipal non-profit enterprise 'Regional Center of Oncology'
      • Kharkiv, Ukraine, 61037
        • Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
      • Khmelnytsky, Ukraine, 29000
        • Khmelnitckiy regional hospital
      • Kropyvnytskyi, Ukraine, 25011
        • Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'
      • Kyiv, Ukraine, 03022
        • National Cancer Institute
      • Kyiv, Ukraine, 03115
        • State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
      • Lviv, Ukraine, 79031
        • Lviv Clinical Regional Hospital
      • Poltava, Ukraine, 36024
        • ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
      • Uzhgorod, Ukraine, 88000
        • Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
      • Zhytomyr, Ukraine, 10002
        • Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council
  • United Kingdom
      • Blackburn, United Kingdom, BB2 3HH
        • Royal Blackburn Hospital
      • London, United Kingdom, WC1E 6BT
        • University College London Hospitals
      • London, United Kingdom, SW7 3RP
        • Royal Marsden Hospital
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center, PC
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates, PC - HAL
      • Tucson, Arizona, United States, 85741
        • Urological Associates of Southern Arizona, P.C.
      • Yuma, Arizona, United States, 85364
        • Yuma Regional Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Urology
    • California
      • Long Beach, California, United States, 90806
        • MemorialCare Research Miller Children's and Women's Hospital Long Beach
      • Riverside, California, United States, 92505
        • Kaiser Permanente
      • San Bernardino, California, United States, 92506
        • San Bernardino Urological Associates
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic Pharm
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers
      • Denver, Colorado, United States, 80211
        • The Urology Center of Colorado
      • Golden, Colorado, United States, 80401
        • Foothills Urology - Golden Off
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology & Oncology Assoc.
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Advanced Urology Institute
      • Fort Lauderdale, Florida, United States, 33308-4668
        • Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
      • Ocala, Florida, United States, 34474
        • Ocala Oncology Center
      • Pensacola, Florida, United States, 32503
        • Woodlands Medical Specialists, PA
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood Center, LLC
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care
    • Illinois
      • Chicago Ridge, Illinois, United States, 60415
        • Affiliated Oncologists, LLC
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology and Hematology, Inc.
      • Jeffersonville, Indiana, United States, 47130
        • First Urology
      • South Bend, Indiana, United States, 46601
        • Beacon Medical Group Clinical Research
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Pontchartrain Cancer Center
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology, PA
      • Frederick, Maryland, United States, 21702-4337
        • Frederick Health Hospital - James M Stockman Cancer Institute
      • Towson, Maryland, United States, 21204
        • Chesapeake Urology Associates
    • Massachusetts
      • Plymouth, Massachusetts, United States, 02360
        • Beth Israel Deaconess Hospital Plymouth, Jordan Club Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Lansing, Michigan, United States, 48219
        • Edward W Sparrow Hospital
      • Troy, Michigan, United States, 48084
        • Michigan Institute of Urology
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, P.A.
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Central Care Cancer Center
      • Saint Joseph, Missouri, United States, 64507
        • Mosaic Life Care
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Nebraska Cancer Specialists
      • Omaha, Nebraska, United States, 68130
        • GU Research Network
      • Omaha, Nebraska, United States, 68114
        • Adult Pediatric Urology & Urogynecology, P.C
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • New York, New York, United States, 10029
        • Tisch Cancer Institution
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals
      • Syracuse, New York, United States, 13210
        • Upstate Cancer Center
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute, LLC
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute and Research Center
      • Portland, Oregon, United States, 97213-2982
        • Northwest Cancer Specialists PC
      • Salem, Oregon, United States, 97301
        • Oregon Oncology Specialists
      • Springfield, Oregon, United States, 97477
        • Oregon Urology Institute
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Centers for Advanced Urology LLC d b a MidLantic Urology
      • Gettysburg, Pennsylvania, United States, 17325
        • Gettysburg Cancer Center
      • Horsham, Pennsylvania, United States, 19044
        • Consultants in Medical Oncology and Hematology, P.C. - Abington
      • Lancaster, Pennsylvania, United States, 17601
        • Lancaster Urology
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center (Upmc)
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Prisma Health
      • Myrtle Beach, South Carolina, United States, 29572
        • Atlantic Urology Clinics
    • Texas
      • Abilene, Texas, United States, 79606
        • Texas Onc.
      • Amarillo, Texas, United States, 79106
        • Texas Oncology-Amarillo
      • Austin, Texas, United States, 78731
        • Texas Oncology-Austin
      • Beaumont, Texas, United States, 77702-1449
        • Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center
      • Denton, Texas, United States, 76201
        • Texas Oncology-Denton South
      • Flower Mound, Texas, United States, 75028
        • Texas Oncology, P.A. - Flower Mound
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology-Fort Worth Cancer Center
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77024
        • Texas Oncology-Memorial City
      • Houston, Texas, United States, 77027
        • Houston Metro Urology
      • Houston, Texas, United States, 77070
        • Texas Oncology - Willowbrook
      • Longview, Texas, United States, 75601
        • Texas Oncology P.A.
      • McAllen, Texas, United States, 78503
        • Texas Oncology P.A.
      • Mesquite, Texas, United States, 75150
        • Texas Oncology-Mesquite
      • Midland, Texas, United States, 79701
        • Texas Oncology-Midland Allison Cancer Center
      • Paris, Texas, United States, 75460
        • Texas Oncology, P.A. - Paris
      • Plano, Texas, United States, 75075
        • Texas Oncology P A
      • Plano, Texas, United States, 75093
        • Texas Oncology P.A.
      • San Antonio, Texas, United States, 78217
        • University of Texas at San Antonio
      • Waco, Texas, United States, 76712
        • Texas Oncology -Waco
      • Webster, Texas, United States, 77598
        • Texas Oncology Deke Slayton Cancer Center
      • Wichita Falls, Texas, United States, 76310
        • Texas Oncology P.A.
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova
      • Leesburg, Virginia, United States, 20176
        • Virginia Cancer Specialists
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Asc
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia, PLCC
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialists
    • Wisconsin
      • Janesville, Wisconsin, United States, 53548
        • Building Oncology Research
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with Metastatic Prostate Cancer
Participants 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.
Other: Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis
Saliva, blood, and/or archival tumor tissue will be collected from the participants with metastatic PC for genomic testing to confirm DRD status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Approximately 2.4 years
Percentage of Participants who Meet Biomarker Eligibility Criteria for Other Niraparib Interventional Studies
Time Frame: Approximately 2.4 years
Percentage of participants who meet biomarker eligibility criteria for other niraparib interventional studies will be assessed.
Approximately 2.4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Approximately 2.4 years
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.
Approximately 2.4 years
Percentage of Participants with 1 or more DNA-repair gene defects with Metastatic Prostate Cancer as an Estimate for Prevalence
Time Frame: Approximately 2.4 years
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.
Approximately 2.4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2019

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

November 22, 2022

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108591
  • 64091742PCR0002 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Prostate Cancer

Clinical Trials on Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe