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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03871816
Other study ID # CR108591
Secondary ID 64091742PCR0002
Status Completed
Phase
First received
Last updated
Start date April 22, 2019
Est. completion date November 22, 2022

Study information

Verified date December 2023
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 14532
Est. completion date November 22, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Argentina Centro Oncológico Korben Buenos Aires
Argentina Hospital Aleman Buenos Aires
Argentina Sociedade Beneficente de Senhoras - Hospital Sírio Libanês Buenos Aires
Argentina CINME - Centro de Investigaciones Metabolicas Caba
Argentina Centro de Urologia (CDU) Ciudad Automoma Buenos Aires
Argentina Hospital Italiano de Buenos Aires Ciudad Autonoma de
Argentina CEMIC Saavedra Ciudad Autonoma de Buenos Aires
Argentina Clínica Adventista Belgrano Ciudad De Buenos Aires
Argentina Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Cordoba
Argentina Centro Urologico Profesor Bengio Cordoba
Argentina Hospital Privado - Centro Medico de Cordoba Cordoba
Argentina Hospital Privado de Comunidad Mar Del Plata
Argentina Centro de Investigacion Pergamino SA Pergamino
Argentina Sanatorio Parque Rosario
Argentina ARS Médica San Salvador De Jujuy
Australia Pindara Private Hospital Benowa
Australia Sunshine Coast University Hospital Birtinya
Australia Chris O'Brien Lifehouse Camperdown
Australia St Vincent's hospital Darlinghurst
Australia Border Medical Oncology East Albury
Australia Royal Hobart Hospital Hobart
Australia Ashford Cancer Centre Kurralta Park
Australia Liverpool Hospital Liverpool
Australia Macquarie University Hospital Macquarie University
Australia Peter MacCallum Cancer Centre Melbourne
Australia Fiona Stanley Hospital Murdoch
Australia Prince Of Wales Hospital Randwick
Australia Sydney Adventist Hospital Wahroonga
Belarus Bobruisk Interregional Oncological Dispensary Bobruisk
Belarus Brest Regional Oncology Dispensary Brest
Belarus Gomel Regional Clinical Oncology Dispensary Gomel
Belarus Grodno University Hospital Grodno
Belarus State Institution N.N. Alexandrov Republican Scientific and Lesnoy
Belarus Minsk city Clinical Oncological Dispensary Minsk
Belarus Mogilev Regional Hospital Mogilev
Belarus Vitebsk Regional Clinical Hospital Vitebsk
Belgium Clinique Notre Dame de Grâce Charleroi
Belgium Jolimont Haine-Saint-Paul, La Louviere
Belgium Clinique Saint Pierre Ottignies
Belgium Algemeen Ziekenhuis Delta Roeselare
Brazil Fundacao Pio XII Barretos
Brazil Cetus Oncologia Belo Horizonte
Brazil PERSONAL - Oncologia de Precisão e Personalizada Belo Horizonte
Brazil Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia Brasilia
Brazil CIONC - Centro Integrado de Oncologia de Curitiba Curitiba
Brazil Liga Paranaense de Combate ao Cancer Curitiba
Brazil Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN Florianopolis
Brazil Suporte Nutricional e Quimioterapia Ltda-Pronutrir Fortaleza
Brazil Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge Goiania
Brazil Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda Ijui
Brazil Fundação São Francisco Xavier Ipatinga
Brazil Clínica de Neoplasias Litoral Ltda. Itajai
Brazil Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia Joinville
Brazil Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda. Maceio
Brazil Liga Norte Riograndense Contra O Cancer Natal
Brazil Hospital Ernesto Dornelles Porto Alegre
Brazil Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre
Brazil MultiHemo Servicos Medicos S.A Recife
Brazil Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) Rio de Janeiro
Brazil Oncoclínicas Rio de Janeiro S.A. Rio de Janeiro
Brazil Universidade do Estado do Rio de Janeiro - UERJ Rio de Janeiro
Brazil Hospital Sao Rafael Salvador
Brazil Nucleo de Oncologia da Bahia Salvador
Brazil CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia Santo André
Brazil Fundacao Antonio Prudente - A.C. Camargo Cancer Center Sao Paulo
Brazil Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo Sao Paulo
Brazil Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE Sao Paulo
Brazil Instituto de Ensino e Pesquisa São Lucas Sao Paulo
Brazil Irmandade Santa Casa de Misericordia de Sao Paulo Sao Paulo
Brazil Instituto do Cancer Arnaldo Vieira de Carvalho São Paulo
Brazil Núcleo de Pesquisa São Camilo São Paulo
Brazil Real e Benemérita Associação Portuguesa de Beneficência São Paulo
Brazil IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado Sorocaba
Brazil Instituto do Cancer De Tres Lagoas Tres Lagoas
Bulgaria MHAT Deva Maria Burgas
Bulgaria UMHAT 'Dr. Georgi Stranski', EAD Pleven
Bulgaria District Oncology Dispensary with In-Patient Stationary - Plovdiv Plovdiv
Bulgaria Comprehensive Cancer Center Vratsa
Canada Southern Alberta Institute of Urology / Prostate Cancer Centre Calgary Alberta
Canada McMaster Institute of Urology Hamilton Ontario
Canada Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre) Kingston Ontario
Canada Centre de Recherche du CHUM Montreal Quebec
Canada Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc Quebec
Canada University Health Network (UHN) Princess Margaret Cancer Centre Toronto Ontario
Canada British Columbia Cancer Agency (BCCA) - Vancouver Centre Vancouver British Columbia
Canada British Columbia Cancer Agency - Vancouver Island Centre Victoria British Columbia
Denmark Copenhagen University Hospital Copenhagen
Denmark Næstved Hospital Naestved
France Institut Sainte Catherine Avignon
France Centre Hospitalier Regional Universitaire Besancon Besançon
France Institut Bergonié Bordeaux
France Centre Jean Perrin Clermont Ferrand
France Centre Oscar Lambret Lille
France Centre Leon Bérard Lyon
France Polyclinique de Gentilly Nancy
France Centre Antoine Lacassagne Nice
France Hopital Europeen Georges-Pompidou Paris Cedex 15
France Institut de Cancérologie de l'Ouest (ICO) Saint Herblain
France HIA Begin Saint Mande
France Institut de Cancérologie de Loire Saint-Priest-en-Jarez
France Clinique Sainte Anne Strasbourg
France Hôpitaux Universitaire de Strasbourg -CHU Strasbourg
France Hopital Foch Suresnes
France CHRU de Tours Tours
France Institut Gustave Roussy Villejuif
Germany Urologisches Zentrum Bonn Bonn
Germany Urologie im Schlosscarree Schreier/Eichler/Junius - Germany Braunschweig
Germany Zeisigwaldkliniken Bethanien Chemnitz Chemnitz
Germany Urologische Gemeinschaftspraxis Böhm/Linne - Germany Dresden
Germany uro Eimsbüttel - Gemeinschaftspraxis Bath/Weinzierl Hamburg
Germany Klinikum Region Hannover Klinikum Siloah Hannover
Germany Matthias Schulze - Germany Markkleeberg
Germany CUROS - Uberörtliche urologische Gemeinschaftspraxis Wesseling
Israel Soroka Hospital Beer-Sheva
Israel Rambam Hospital Haifa
Israel Rabin Medical Center Petah Tikva
Israel Sheba Medical Center Ramat Gan
Israel Asaf Harofe Medical Center Zrifin
Italy Ospedale Cardinal Massaia Asti
Italy Ospedale Sacro Cuore Di Gesu Benevento
Italy Azienda Ospedaliera Papa Giovanni XXIII Bergamo
Italy Ospedale di Bolzano Bolzano
Italy oncologia medica - Oncology Brindisi
Italy Azienda Ulss 6 Euganea- Ospedale Di Camposampiero Camposampiero
Italy Ospedale Di Carrara Carrara
Italy AORN Sant'anna e San Sebastiano Caserta
Italy ASST -Ospedale Maggiore di Crema Crema
Italy Azienda ULSS 3 Serenissima, presidio di Mirano Mirano
Italy PP.OO. di Piombino e Portoferraio Azienda USL Toscana nord ovest Piombino
Italy Ospedale degli Infermi Ponderano
Italy Ospedale del Mare ASL Napoli 1 centro Ponticelli
Italy Azienda ULSS5 Polesana di Rovigo - Ospedale Santa Maria della Misericordia Rovigo
Italy PO Ospedale S.Anna, ASST Lariana San Fermo della Battaglia
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Keimyung University Dongsan Hospital Daegu
Korea, Republic of Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of National Cancer Center Goyang-Si
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Ajou University Hospital Gyeonggi-do
Korea, Republic of Seoul National University Bundang Hospital Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Seoul St. Mary's Hospital Seoul
Malaysia Hospital Pulau Pinang George Town
Malaysia Hospital Kuala Lumpur Kuala Lumpur
Malaysia University Malaya Medical Centre Kuala Lumpur
Malaysia Sarawak General Hospital Kuching
Netherlands Renier de Graaf Delft
Netherlands Canisius-Wilhelmina Ziekenhuis Nijmegen
Netherlands Elisabeth-TweeSteden Ziekenhuis Tilburg
Poland Centrum Onkologii im. Prof. F. Lukaszczyka Bydgoszcz
Poland Uniwersyteckie Centrum Kliniczne Gdansk
Poland Szpitale Pomorskie Sp. z o.o. Gdynia
Poland Przychodnia Lekarska KOMED Roman Karaszewski Konin
Poland Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lodz
Poland Urologica Praktyka Lekarska Adam Marcheluk Siedlce
Poland Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
Poland Szpital Grochowski im. dr med. Rafala Masztaka Sp. z o.o. Warszawa
Poland Specjalistyczna przychodnia lekarska POLIMED Wroclaw
Russian Federation Altai Regional Oncology Dispensary Barnaul
Russian Federation Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine Chelyabinsk
Russian Federation Ivanovo Regional Oncology Dispensary Ivanovo
Russian Federation Hertzen Oncology Research Institute Moscow
Russian Federation Moscow City Clinical Hospital # 62 Moscow
Russian Federation Russian Scientific Center of Roentgenoradiology Moscow
Russian Federation Privolzhsky District Medical Centre Nizhny Novgorod
Russian Federation Clinical Oncology Dispensary Omsk
Russian Federation Pyatigorsk Interdistrict Oncology Dispensary Pyatigorsk
Russian Federation Leningrad Regional Oncology Dispensary Saint-Petersburg
Russian Federation Republican Oncology Dispensary Saransk
Russian Federation Multifunctional clinical medical center 'Medical city' Tyumen
Russian Federation Bashkir State Medical University Ufa
Spain Hosp. Univ. A Coruna A Coruña
Spain Hosp. Clinic de Barcelona Barcelona
Spain Hosp. de La Santa Creu I Sant Pau Barcelona
Spain Hosp. Gral. Univ. de Castellon Castellon
Spain Institut Català D'Oncologia Girona Girona
Spain Hosp. Univ. de Jaen Jaén
Spain Hosp. de Jerez de La Frontera Jerez de la Frontera
Spain Hosp. Univ. Arnau de Vilanova de Lleida Lleida
Spain Hosp. Univ. 12 de Octubre Madrid
Spain Hosp. Univ. de La Princesa Madrid
Spain Hosp. Univ. Del Henares Madrid
Spain Hosp. Univ. Hm Monteprincipe Madrid
Spain Hosp. Univ. Infanta Leonor Madrid
Spain Hosp. Univ. La Paz Madrid
Spain Hosp. Univ. Ramon Y Cajal Madrid
Spain Hosp. Virgen de La Victoria Málaga
Spain Complexo Hosp. Univ. de Ourense Ourense
Spain Hosp. Univ. Infanta Cristina Parla, Madrid
Spain Hosp. Puerto Real Puerto Real, Cádiz
Spain Corporacio Sanitari Parc Tauli Sabadell
Spain Hosp. Univ. Marques de Valdecilla Santander
Spain Hosp. Virgen Del Rocio Sevilla
Spain Hosp. de Sant Pau I Santa Tecla Tarragona
Spain Hosp. de Terrassa Terrassa
Spain Hosp. Clinico Univ. de Valencia Valencia
Sweden Skanes universitetssjukhus Malmö
Sweden Södersjukhuset Stockholm
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan Tungs' Taichung MetroHarbor Hospital Taichung
Taiwan Chi Mei Medical Center - Yong Kang Tainan
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Tri-Service General Hospital Taipei
Taiwan Chang Gung Memorial Hospital Taoyuan
Thailand King Chulalongkorn Memorial Hospital Bangkok
Thailand Ramathibodi Hospital Bangkok
Thailand Siriraj Hospital Bangkok
Turkey Ankara Bilkent City Hospital Ankara
Turkey Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital Ankara
Turkey Memorial Ankara Hastanesi Ankara
Turkey Akdeniz University Medical Faculty Antalya
Turkey Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi Bursa
Turkey Trakya University Medical Faculty Edirne
Turkey Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd Istanbul
Turkey Istanbul University Istanbul Medical Faculty Istanbul
Turkey T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Istanbul
Turkey Izmir Medical Park Hospital Izmir
Turkey Sakarya University Training and Research Hospital Sakarya
Ukraine Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' Cherkasy
Ukraine Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc Dnipo
Ukraine Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council Dnipro
Ukraine Ivano-Frankivsk Regional Clinical Hospital Ivano-Frankivsk
Ukraine Communal Institution 'City hospital ?7 of Kamianske' of Dnepropetrov'sk Regional Council Kamianske
Ukraine Municipal non-profit enterprise 'Regional Center of Oncology' Khakhiv
Ukraine Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval Kharkiv
Ukraine Khmelnitckiy regional hospital Khmelnytsky
Ukraine Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council' Kropyvnytskyi
Ukraine National Cancer Institute Kyiv
Ukraine State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center Kyiv
Ukraine Lviv Clinical Regional Hospital Lviv
Ukraine ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council' Poltava
Ukraine Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal Uzhgorod
Ukraine Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council Zhytomyr
United Kingdom Royal Blackburn Hospital Blackburn
United Kingdom Royal Marsden Hospital London
United Kingdom University College London Hospitals London
United States Texas Onc. Abilene Texas
United States New York Oncology Hematology Albany New York
United States Texas Oncology-Amarillo Amarillo Texas
United States University Cancer & Blood Center, LLC Athens Georgia
United States Rocky Mountain Cancer Centers Aurora Colorado
United States Texas Oncology-Austin Austin Texas
United States Centers for Advanced Urology LLC d b a MidLantic Urology Bala-Cynwyd Pennsylvania
United States Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center Beaumont Texas
United States Central Care Cancer Center Bolivar Missouri
United States Montefiore Medical Center Bronx New York
United States University of Virginia Charlottesville Virginia
United States Affiliated Oncologists, LLC Chicago Ridge Illinois
United States Maryland Oncology Hematology, PA Columbia Maryland
United States Pontchartrain Cancer Center Covington Louisiana
United States Methodist Dallas Medical Center Dallas Texas
United States Advanced Urology Institute Daytona Beach Florida
United States Texas Oncology-Denton South Denton Texas
United States The Urology Center of Colorado Denver Colorado
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Willamette Valley Cancer Institute and Research Center Eugene Oregon
United States INOVA Fairfax Virginia
United States Texas Oncology, P.A. - Flower Mound Flower Mound Texas
United States Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center Fort Lauderdale Florida
United States Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne Indiana
United States Texas Oncology-Fort Worth Cancer Center Fort Worth Texas
United States Frederick Health Hospital - James M Stockman Cancer Institute Frederick Maryland
United States Gettysburg Cancer Center Gettysburg Pennsylvania
United States Foothills Urology - Golden Off Golden Colorado
United States Southeastern Medical Oncology Center Goldsboro North Carolina
United States Prisma Health Greenville South Carolina
United States Urology Centers Of Alabama Homewood Alabama
United States Hawaii Cancer Care Honolulu Hawaii
United States Consultants in Medical Oncology and Hematology, P.C. - Abington Horsham Pennsylvania
United States Houston Metro Urology Houston Texas
United States MD Anderson Cancer Center Houston Texas
United States Texas Oncology - Willowbrook Houston Texas
United States Texas Oncology-Memorial City Houston Texas
United States Cancer Specialists of North Florida Jacksonville Florida
United States Building Oncology Research Janesville Wisconsin
United States First Urology Jeffersonville Indiana
United States Lancaster Urology Lancaster Pennsylvania
United States Edward W Sparrow Hospital Lansing Michigan
United States Virginia Cancer Specialists Leesburg Virginia
United States Arkansas Urology Little Rock Arkansas
United States MemorialCare Research Miller Children's and Women's Hospital Long Beach Long Beach California
United States Texas Oncology P.A. Longview Texas
United States Norton Healthcare Louisville Kentucky
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Texas Oncology P.A. McAllen Texas
United States Texas Oncology-Mesquite Mesquite Texas
United States Miami Cancer Institute at Baptist Health / Baptist Health Medical Group Miami Florida
United States Texas Oncology-Midland Allison Cancer Center Midland Texas
United States Minnesota Oncology Hematology, P.A. Minneapolis Minnesota
United States Southern Cancer Center, PC Mobile Alabama
United States Atlantic Urology Clinics Myrtle Beach South Carolina
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Tisch Cancer Institution New York New York
United States Virginia Oncology Asc Norfolk Virginia
United States Eastern Connecticut Hematology & Oncology Assoc. Norwich Connecticut
United States Ocala Oncology Center Ocala Florida
United States Adult Pediatric Urology & Urogynecology, P.C Omaha Nebraska
United States GU Research Network Omaha Nebraska
United States Nebraska Cancer Specialists Omaha Nebraska
United States Texas Oncology, P.A. - Paris Paris Texas
United States Woodlands Medical Specialists, PA Pensacola Florida
United States Illinois Cancer Care Peoria Illinois
United States Arizona Oncology Associates, PC - HAL Phoenix Arizona
United States Mayo Clinic Phoenix Arizona
United States University of Pittsburgh Medical Center (UPMC) Pittsburgh Pennsylvania
United States Texas Oncology P A Plano Texas
United States Texas Oncology P.A. Plano Texas
United States Beth Israel Deaconess Hospital Plymouth, Jordan Club Cancer Center Plymouth Massachusetts
United States Northwest Cancer Specialists PC Portland Oregon
United States Kaiser Permanente Riverside California
United States Mosaic Life Care Saint Joseph Missouri
United States Oregon Oncology Specialists Salem Oregon
United States University of Texas at San Antonio San Antonio Texas
United States San Bernardino Urological Associates San Bernardino California
United States Sansum Clinic Pharm Santa Barbara California
United States Beacon Medical Group Clinical Research South Bend Indiana
United States Oregon Urology Institute Springfield Oregon
United States Associated Medical Professionals Syracuse New York
United States Upstate Cancer Center Syracuse New York
United States Northwest Medical Specialists Tacoma Washington
United States Chesapeake Urology Associates Towson Maryland
United States Michigan Institute of Urology Troy Michigan
United States Urological Associates of Southern Arizona, P.C. Tucson Arizona
United States Oklahoma Cancer Specialists and Research Institute, LLC Tulsa Oklahoma
United States Urology of Virginia, PLCC Virginia Beach Virginia
United States Texas Oncology -Waco Waco Texas
United States Texas Oncology Deke Slayton Cancer Center Webster Texas
United States Texas Oncology P.A. Wichita Falls Texas
United States Yuma Regional Medical Center Yuma Arizona

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belarus,  Belgium,  Brazil,  Bulgaria,  Canada,  Denmark,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Netherlands,  Poland,  Russian Federation,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Approximately 2.4 years
Primary 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. Approximately 2.4 years
Secondary 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. Approximately 2.4 years
Secondary 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. Approximately 2.4 years
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