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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Netherlands3 sites
Renier de Graaf
Delft, 2625 AD
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6524 KD
Elisabeth-TweeSteden Ziekenhuis
Tilburg, 5022 GC
Thailand3 sites
Ramathibodi Hospital
Bangkok, 10400
King Chulalongkorn Memorial Hospital
Bangkok, 10500
Siriraj Hospital
Bangkok, 10700
United Kingdom3 sites
Royal Blackburn Hospital
Blackburn, BB2 3HH
Royal Marsden Hospital
London, SW7 3RP
University College London Hospitals
London, WC1E 6BT
Denmark2 sites
Copenhagen University Hospital
Copenhagen, 2100
Næstved Hospital
Næstved, 4700
Sweden2 sites
Skanes universitetssjukhus
Malmö, 20502
Södersjukhuset
Stockholm, 11883
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.
- Conditions
- Metastatic Prostate Cancer
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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
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)
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
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.
- First posted12 Mar 2019
- Study start22 Apr 2019
- Primary completion30 Oct 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT03871816
- Acronym / sponsor ID
- CR108591
- Conditions
- Metastatic Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,532 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Metastatic Prostate Cancer | – | Other: Saliva, Blood, or and/or Archival Tumor Tissue Collection and AnalysisParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva, Blood, or and/or Archival Tumor Tissue Collection and AnalysisSaliva, blood, and/or archival tumor tissue will be collected from the participants with metastatic PC for genomic testing to confirm DRD status. | Other | Participants with Metastatic Prostate Cancer |
Primary outcome
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.
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.
2 secondary outcomes
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 1 or more DNA-repair gene defects with Metastatic Prostate Cancer as an Estimate for Prevalence
Time frame: Approximately 2.4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
Related trials for Metastatic Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
338 sites in 25 countries: see every site and its status.
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.