Trial record 1 of 2 for:
janssen prevalence | prostate cancer
A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03871816 |
Recruitment Status :
Recruiting
First Posted : March 12, 2019
Last Update Posted : March 29, 2021
|
Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
- Study Details
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Brief 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.
Condition or disease | Intervention/treatment |
---|---|
Metastatic Prostate Cancer | Other: Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis |
Study Type : | Observational |
Estimated Enrollment : | 10000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer |
Actual Study Start Date : | April 22, 2019 |
Estimated Primary Completion Date : | July 26, 2021 |
Estimated Study Completion Date : | September 18, 2023 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Prostate cancer
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. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
- 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.
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
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.
Criteria
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871816
Contacts
Contact: Study Contact | 844-434-4210 | JNJ.CT@sylogent.com |
Locations


United States, Alabama | |
Urology Centers Of Alabama | Recruiting |
Homewood, Alabama, United States, 35209 | |
Southern Cancer Center, PC | Recruiting |
Mobile, Alabama, United States, 36608 | |
United States, Arizona | |
Arizona Oncology Associates, PC - HAL | Recruiting |
Phoenix, Arizona, United States, 85016 | |
Mayo Clinic | Recruiting |
Phoenix, Arizona, United States, 85054 | |
Southern Arizona VA Healthcare System | Withdrawn |
Tucson, Arizona, United States, 85723 | |
Urological Associates of Southern Arizona, P.C. | Recruiting |
Tucson, Arizona, United States, 85741 | |
Yuma Regional Medical Center | Recruiting |
Yuma, Arizona, United States, 85364 | |
United States, Arkansas | |
Arkansas Urology | Recruiting |
Little Rock, Arkansas, United States, 72211 | |
United States, California | |
University of Southern California | Withdrawn |
Los Angeles, California, United States, 90089 | |
Kaiser Permanente | Recruiting |
Riverside, California, United States, 92505 | |
San Bernardino Urological Associates | Recruiting |
San Bernardino, California, United States, 92506 | |
Sansum Clinic Pharm | Recruiting |
Santa Barbara, California, United States, 93105 | |
United States, Colorado | |
Rocky Mountain Cancer Centers | Not yet recruiting |
Aurora, Colorado, United States, 80012 | |
The Urology Center of Colorado | Recruiting |
Denver, Colorado, United States, 80211 | |
UC Health Cancer Center | Withdrawn |
Fort Collins, Colorado, United States, 80528 | |
Foothills Urology - Golden Off | Recruiting |
Golden, Colorado, United States, 80401 | |
United States, Florida | |
Advanced Urology Institute | Recruiting |
Daytona Beach, Florida, United States, 32114 | |
Cancer Specialists of North Florida | Recruiting |
Jacksonville, Florida, United States, 32256 | |
University of Florida | Withdrawn |
Jacksonville, Florida, United States, 33209 | |
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group | Recruiting |
Miami, Florida, United States, 33176 | |
Woodlands Medical Specialists, PA | Recruiting |
Pensacola, Florida, United States, 32503 | |
United States, Georgia | |
University Cancer & Blood Center, LLC | Not yet recruiting |
Athens, Georgia, United States, 30607 | |
United States, Illinois | |
Affiliated Oncologists, LLC | Recruiting |
Chicago Ridge, Illinois, United States, 60415 | |
University of Chicago | Suspended |
Chicago, Illinois, United States, 60637 | |
Illinois Cancer Care | Recruiting |
Peoria, Illinois, United States, 61615 | |
United States, Indiana | |
Fort Wayne Medical Oncology and Hematology, Inc. | Recruiting |
Fort Wayne, Indiana, United States, 46804 | |
First Urology | Recruiting |
Jeffersonville, Indiana, United States, 47130 | |
Beacon Medical Group Clinical Research | Recruiting |
South Bend, Indiana, United States, 46601 | |
United States, Kentucky | |
Norton Healthcare | Completed |
Louisville, Kentucky, United States, 40202 | |
United States, Louisiana | |
Pontchartrain Cancer Center | Recruiting |
Covington, Louisiana, United States, 70433 | |
Ochsner Clinic Foundation | Not yet recruiting |
New Orleans, Louisiana, United States, 70121 | |
United States, Maryland | |
Maryland Oncology Hematology, PA | Recruiting |
Columbia, Maryland, United States, 21044 | |
Frederick Health Hospital - James M Stockman Cancer Institute | Recruiting |
Frederick, Maryland, United States, 21702-4337 | |
Chesapeake Urology Associates | Recruiting |
Towson, Maryland, United States, 21204 | |
United States, Massachusetts | |
Massachusetts General | Withdrawn |
Boston, Massachusetts, United States, 02115 | |
Dana Farber Cancer Center | Suspended |
Boston, Massachusetts, United States, 02215 | |
Beth Israel Deaconess Hospital Plymouth, Jordan Club Cancer Center | Recruiting |
Plymouth, Massachusetts, United States, 02360 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201 | |
Michigan Institute of Urology | Recruiting |
Troy, Michigan, United States, 48084 | |
United States, Minnesota | |
Minnesota Oncology Hematology, P.A. | Recruiting |
Minneapolis, Minnesota, United States, 55404 | |
United States, Missouri | |
Central Care Cancer Center | Recruiting |
Bolivar, Missouri, United States, 65613 | |
United States, Nebraska | |
Adult Pediatric Urology & Urogynecology, P.C | Recruiting |
Omaha, Nebraska, United States, 68114 | |
GU Research Network | Recruiting |
Omaha, Nebraska, United States, 68130 | |
Nebraska Cancer Specialists | Recruiting |
Omaha, Nebraska, United States, 68130 | |
United States, New York | |
New York Oncology Hematology | Recruiting |
Albany, New York, United States, 12208 | |
Montefiore Medical Center | Recruiting |
Bronx, New York, United States, 10461 | |
Northwell Health Cancer Institute | Withdrawn |
Lake Success, New York, United States, 11042 | |
Tisch Cancer Institution | Recruiting |
New York, New York, United States, 10029 | |
Memorial Sloan Kettering Cancer Center | Withdrawn |
New York, New York, United States, 10065 | |
Memorial Sloan-Kettering Cancer Center | Suspended |
New York, New York, United States, 10065 | |
Associated Medical Professionals | Not yet recruiting |
Syracuse, New York, United States, 13210 | |
Upstate Cancer Center | Recruiting |
Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
Duke Cancer Institute | Withdrawn |
Durham, North Carolina, United States, 27710 | |
Southeastern Medical Oncology Center | Not yet recruiting |
Goldsboro, North Carolina, United States, 27534 | |
United States, Ohio | |
Cleveland Clinic | Suspended |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Willamette Valley Cancer Institute and Research Center | Recruiting |
Eugene, Oregon, United States, 97401 | |
Northwest Cancer Specialists PC | Recruiting |
Portland, Oregon, United States, 97213-2982 | |
Oregon Oncology Specialists | Recruiting |
Salem, Oregon, United States, 97301 | |
Oregon Urology Institute | Recruiting |
Springfield, Oregon, United States, 97477 | |
United States, Pennsylvania | |
Centers for Advanced Urology, LLC; d/b/a MidLantic Urology | Recruiting |
Bala-Cynwyd, Pennsylvania, United States, 19004 | |
Gettysburg Cancer Center | Recruiting |
Gettysburg, Pennsylvania, United States, 17325 | |
Consultants in Medical Oncology and Hematology, P.C. - Abington | Recruiting |
Horsham, Pennsylvania, United States, 19044 | |
Lancaster Urology | Recruiting |
Lancaster, Pennsylvania, United States, 17601 | |
Thomas Jefferson University | Withdrawn |
Philadelphia, Pennsylvania, United States, 19107 | |
University of Pittsburgh Medical Center (UPMC) | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, South Carolina | |
Prisma Health | Recruiting |
Greenville, South Carolina, United States, 29615 | |
Atlantic Urology Clinics | Recruiting |
Myrtle Beach, South Carolina, United States, 29572 | |
United States, Texas | |
Texas Onc. | Completed |
Abilene, Texas, United States, 79606 | |
Texas Oncology-Amarillo | Recruiting |
Amarillo, Texas, United States, 79106 | |
Texas Oncology-Austin | Recruiting |
Austin, Texas, United States, 78731 | |
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center | Recruiting |
Beaumont, Texas, United States, 77702-1449 | |
Methodist Dallas Medical Center | Recruiting |
Dallas, Texas, United States, 75203 | |
Texas Oncology-Denton South | Recruiting |
Denton, Texas, United States, 76201 | |
Texas Oncology, P.A. - Flower Mound | Recruiting |
Flower Mound, Texas, United States, 75028 | |
Texas Oncology-Fort Worth Cancer Center | Completed |
Fort Worth, Texas, United States, 76104 | |
Texas Oncology-Memorial City | Not yet recruiting |
Houston, Texas, United States, 77024 | |
Houston Metro Urology | Recruiting |
Houston, Texas, United States, 77027 | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Texas Oncology - Willowbrook | Recruiting |
Houston, Texas, United States, 77070 | |
Texas Oncology P.A. | Recruiting |
Longview, Texas, United States, 75601 | |
Texas Oncology P.A. | Recruiting |
McAllen, Texas, United States, 78503 | |
Texas Oncology-Mesquite | Recruiting |
Mesquite, Texas, United States, 75150 | |
Texas Oncology-Midland Allison Cancer Center | Completed |
Midland, Texas, United States, 79701 | |
Texas Oncology, P.A. - Paris | Recruiting |
Paris, Texas, United States, 75460 | |
Texas Oncology P A | Recruiting |
Plano, Texas, United States, 75075 | |
Texas Oncology P.A. | Recruiting |
Plano, Texas, United States, 75093 | |
University of Texas at San Antonio | Recruiting |
San Antonio, Texas, United States, 78217 | |
Texas Oncology -Waco | Recruiting |
Waco, Texas, United States, 76712 | |
Texas Oncology Deke Slayton Cancer Center | Recruiting |
Webster, Texas, United States, 77598 | |
Texas Oncology P.A. | Completed |
Wichita Falls, Texas, United States, 76310 | |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
INOVA | Recruiting |
Fairfax, Virginia, United States, 22031 | |
Virginia Cancer Specialists | Recruiting |
Leesburg, Virginia, United States, 20176 | |
Virginia Oncology Asc | Recruiting |
Norfolk, Virginia, United States, 23502 | |
Urology of Virginia, PLCC | Recruiting |
Virginia Beach, Virginia, United States, 23462 | |
United States, Washington | |
University of Washington School of Medicine | Withdrawn |
Seattle, Washington, United States, 98195 | |
Northwest Medical Specialists | Recruiting |
Tacoma, Washington, United States, 98405 | |
United States, Wisconsin | |
Building Oncology Research | Recruiting |
Janesville, Wisconsin, United States, 53548 | |
University of Wisconsin Carbone Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Argentina | |
Hospital Aleman | Recruiting |
Buenos Aires, Argentina, C1118AAT | |
Hospital Sirio Libanes | Not yet recruiting |
Buenos Aires, Argentina, C1419AHN | |
Hospital Militar Cosme Argerich | Not yet recruiting |
C.a.b.a., Argentina, C1426BOR | |
Fundación CENIT para la Investigación en Neurociencias | Recruiting |
Capital Federal, Argentina, CP 1125 | |
Centro de Urologia (CDU) | Not yet recruiting |
Ciudad Automoma Buenos Aires, Argentina, C1120AAT | |
Cinme - Centro De Investigaciones Metabolicas | Not yet recruiting |
Ciudad Autonoma de Buenos Aires, Argentina, C1027AAP | |
CEMIC Saavedra | Recruiting |
Ciudad Autonoma de Buenos Aires, Argentina, C1431FWN | |
Hospital Italiano de Buenos Aires | Not yet recruiting |
Ciudad Autonoma de, Argentina, C1199ABB | |
Clínica Adventista Belgrano | Recruiting |
Ciudad De Buenos Aires, Argentina, C1430EGF | |
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Recruiting |
Cordoba, Argentina, 5000 | |
Centro Urologico Profesor Bengio | Recruiting |
Cordoba, Argentina, X5000KPH | |
Hospital Privado - Centro Medico de Cordoba | Recruiting |
Cordoba, Argentina, X5016KEH | |
Instituto de Investigaciones Clinicas Mar del Plata | Withdrawn |
Mar Del Plata, Argentina, B7600FZN | |
Hospital Privado de Comunidad | Recruiting |
Mar Del Plata, Argentina, B7602CBM | |
Centro de Investigacion Pergamino SA | Recruiting |
Pergamino, Argentina, B2700CPM | |
Sanatorio Parque | Recruiting |
Rosario, Argentina, S2000SDV | |
ARS Médica | Recruiting |
San Salvador De Jujuy, Argentina, Y4600AFW | |
Australia | |
Pindara Private Hospital | Recruiting |
Benowa, Australia, 4217 | |
Sunshine Coast University Hospital | Recruiting |
Birtinya, Australia, 4575 | |
Princess Alexandra Hospital | Withdrawn |
Brisbane, Australia, 4102 | |
Chris O'Brien Lifehouse | Recruiting |
Camperdown, Australia, 2050 | |
St Vincent's hospital | Recruiting |
Darlinghurst, Australia, 2010 | |
Border Medical Oncology | Recruiting |
East Albury, Australia, 2640 | |
Royal Hobart Hospital | Recruiting |
Hobart, Australia, 7000 | |
Ashford Cancer Centre | Recruiting |
Kurralta Park, Australia, 5037 | |
Liverpool Hospital | Not yet recruiting |
Liverpool, Australia, 2170 | |
Peter MacCallum Cancer Centre | Recruiting |
Melbourne, Australia, 3000 | |
Fiona Stanley Hospital | Recruiting |
Murdoch, Australia, 6150 | |
Macquarie University Hospital | Recruiting |
NSW, Australia, 2109 | |
Prince Of Wales Hospital | Recruiting |
Randwick, Australia, 2031 | |
St John of God Subiaco Hospital | Not yet recruiting |
Subiaco, Australia, 6008 | |
Sydney Adventist Hospital | Recruiting |
Wahroonga, Australia, 2076 | |
Belarus | |
Bobruisk Interregional Oncological Dispensary | Not yet recruiting |
Bobruisk, Belarus, 213825 | |
Brest Regional Oncology Dispensary | Not yet recruiting |
Brest, Belarus, 224027 | |
Gomel Regional Clinical Oncology Dispensary | Not yet recruiting |
Gomel, Belarus, 246012 | |
Grodno University Hospital | Not yet recruiting |
Grodno, Belarus, 230017 | |
State Institution N.N. Alexandrov Republican Scientific and | Not yet recruiting |
Lesnoy, Belarus, 223040 | |
Minsk city Clinical Oncological Dispensary | Not yet recruiting |
Minsk, Belarus, 220013 | |
Mogilev Regional Hospital | Not yet recruiting |
Mogilev, Belarus, 212018 | |
Vitebsk Regional Clinical Hospital | Not yet recruiting |
Vitebsk, Belarus, 210603 | |
Belgium | |
Clinique Notre Dame de Grâce | Not yet recruiting |
Charleroi, Belgium, 6000 | |
Jolimont | Not yet recruiting |
Haine-Saint-Paul, La Louviere, Belgium, 7100 | |
Clinique Saint Pierre | Not yet recruiting |
Ottignies, Belgium, 1340 | |
Algemeen Ziekenhuis Delta | Not yet recruiting |
Roeselare, Belgium, 8800 | |
Brazil | |
Hospital Do Cancer De Barretos - Fundacao Pio Xii | Recruiting |
Barretos, Brazil, 14784-400 | |
Cetus Oncologia | Not yet recruiting |
Belo Horizonte, Brazil, 30110-022 | |
PERSONAL - Oncologia de Precisão e Personalizada | Recruiting |
Belo Horizonte, Brazil, 30130-090 | |
Hospital Sírio Libanes Unidade Brasilia | Recruiting |
Brasilia, Brazil, 70200-730 | |
CIONC - Centro Integrado de Oncologia de Curitiba | Recruiting |
Curitiba, Brazil, 80810-050 | |
Hospital Erasto Gaertner | Recruiting |
Curitiba, Brazil, 81520-060 | |
Centro de Pesquisas Oncológicas - CEPON | Not yet recruiting |
Florianópolis, Brazil, 88034-000 | |
Pronutrir | Recruiting |
Fortaleza, Brazil, 60 810180 | |
Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás | Recruiting |
Goiânia, Brazil, 74605-070 | |
Hospital de Caridade de Ijui | Recruiting |
Ijuí, Brazil, 98700-000 | |
Fundação São Francisco Xavier | Not yet recruiting |
Ipatinga, Brazil, 35162 189 | |
Clínica de Neoplasias Litoral Ltda. | Recruiting |
Itajai, Brazil, 88301-220 | |
Instituto Joinvilense De Hematologia e Oncologia | Recruiting |
Joinville, Brazil, 89201260 | |
Centro de Tratamento de câncer Medradius | Recruiting |
Maceió, Brazil, 57052-765 | |
Liga Norte Riograndense Contra O Cancer | Recruiting |
Natal, Brazil, 59075-740 | |
Irmandade Santa Casa de Misericordia de Porto Alegre | Recruiting |
Porto Alegre, Brazil, 90020-090 | |
Hospital Ernesto Dornelles | Not yet recruiting |
Porto Alegre, Brazil, 90160-093 | |
MultiHemo | Not yet recruiting |
Recife, Brazil, 51020-280 | |
Hospital Universitário Pedro Ernesto | Recruiting |
Rio de Janeiro, Brazil, 20551-030 | |
Oncoclínicas | Recruiting |
Rio De Janeiro, Brazil, 22250-905 | |
Instituto COI de Pesquisa, Educacao e Gestao | Withdrawn |
Rio de Janeiro, Brazil, 22793-080 | |
Instituto COI de Pesquisa, Educacao e Gestao | Recruiting |
Rio de Janeiro, Brazil, 22793-080 | |
Núcleo de Oncologia da Bahia | Not yet recruiting |
Salvador, Brazil, 40170-110 | |
Hospital Sao Rafael | Recruiting |
Salvador, Brazil, 41253-190 | |
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia | Recruiting |
Santo André, Brazil, 09060-650 | |
Centro de Pesquisa do Instituto do Cancer Arnaldo Vieira de Carvalho | Not yet recruiting |
Sao Paulo, Brazil, 01221-020 | |
Santa Casa de Misericordia de São Paulo | Recruiting |
Sao Paulo, Brazil, 01221-020 | |
Instituto de Ensino E Pesquisa Sao Lucas | Recruiting |
Sao Paulo, Brazil, 01236-030 | |
ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA | Not yet recruiting |
Sao Paulo, Brazil, 01246-000 | |
IBCC Instituto Brasileiro de Controle do Cancer | Recruiting |
Sao Paulo, Brazil, 03102-002 | |
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado | Recruiting |
Sorocaba, Brazil, 18030-075 | |
Hospital Beneficência Portuguesa de São Paulo | Not yet recruiting |
São Paulo, Brazil, 01323-001 | |
Fundação Antônio Prudente - A.C. Camargo Cancer Center | Recruiting |
São Paulo, Brazil, 01509-900 | |
Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO | Recruiting |
São Paulo, Brazil, 04039-004 | |
Hospital Israelita Albert Einstein | Withdrawn |
São Paulo, Brazil, 05651-900 | |
Instituto do Cancer De Tres Lagoas | Recruiting |
Três Lagoas, Brazil, 79601-001 | |
Bulgaria | |
MHAT Deva Maria | Not yet recruiting |
Burgas, Bulgaria, 8001 | |
UMHAT 'Dr. Georgi Stranski', EAD | Not yet recruiting |
Pleven, Bulgaria, 5800 | |
District Oncology Dispensary with In-Patient Stationary - Plovdiv | Not yet recruiting |
Plovdiv, Bulgaria, 4004 | |
Comprehensive Cancer Center | Not yet recruiting |
Vratsa, Bulgaria, 3001 | |
Canada, Alberta | |
Southern Alberta Institute of Urology / Prostate Cancer Centre | Recruiting |
Calgary, Alberta, Canada, T2V 1P9 | |
Canada, British Columbia | |
British Columbia Cancer Agency (BCCA) - Vancouver Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
British Columbia Cancer Agency - Vancouver Island Centre | Recruiting |
Victoria, British Columbia, Canada, V8R 6V5 | |
Canada, Ontario | |
McMaster Institute of Urology | Recruiting |
Hamilton, Ontario, Canada, L8N 4A6 | |
Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre) | Recruiting |
Kingston, Ontario, Canada, K7L 3N6 | |
University Health Network (UHN) Princess Margaret Cancer Centre | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
Centre de Recherche du CHUM | Recruiting |
Montreal, Quebec, Canada, H2X 0A9 | |
Canada | |
Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc | Completed |
Quebec, Canada, G1R2J6 | |
Denmark | |
Copenhagen University Hospital | Not yet recruiting |
Copenhagen, Denmark, 2100 | |
Næstved Hospital | Not yet recruiting |
Naestved, Denmark, 4700 | |
France | |
Institut de Cancérologie de l'Ouest (ICO) | Not yet recruiting |
Angers Cedex 9, France, 49933 | |
Institut Sainte Catherine | Recruiting |
Avignon, France, 84918 | |
Centre Hospitalier Regional Universitaire Besancon | Recruiting |
Besançon, France, 25030 | |
Institut Bergonié | Recruiting |
Bordeaux, France, 33000 | |
Centre Francois Baclesse | Withdrawn |
Caen, France, 14000 | |
Centre Jean Perrin | Recruiting |
Clermont Ferrand, France, 63011 | |
Centre Oscar Lambret | Not yet recruiting |
Lille, France, 59020 | |
Centre Leon Bérard | Recruiting |
Lyon, France, 69008 | |
Polyclinique de Gentilly | Recruiting |
Nancy, France, 54100 | |
Centre Antoine Lacassagne | Not yet recruiting |
Nice, France, 6189 | |
Hopital Europeen Georges-Pompidou | Recruiting |
Paris Cedex 15, France, 75908 | |
Hôpital Saint Louis | Withdrawn |
Paris, France, 75010 | |
CHU De Poitiers | Not yet recruiting |
Poitiers Cedex, France, 86021 | |
Centre Hopitalier Inter-Communal De Cornouaille | Not yet recruiting |
Quimper, France, 29000 | |
Institut Jean Godinot | Withdrawn |
Reims, France, 51726 | |
Centre de radiothérapie et d'Oncologie médicale de l'Essonne | Not yet recruiting |
Ris Orangis, France, 91130 | |
Institut de Cancérologie de l'Ouest (ICO) | Recruiting |
Saint Herblain, France, 44805 | |
HIA Begin | Recruiting |
Saint Mande, France, 94163 | |
Institut de Cancérologie de Loire | Not yet recruiting |
Saint-Priest-en-Jarez, France, 42271 | |
Clinique Sainte Anne | Not yet recruiting |
Strasbourg, France, 67000 | |
Hôpitaux Universitaire de Strasbourg -CHU | Recruiting |
Strasbourg, France, 67091 | |
Hopital Foch | Not yet recruiting |
Suresnes, France, 32151 | |
CHRU de Tours | Not yet recruiting |
Tours, France, 37044 | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, 94805 | |
Israel | |
Soroka Hospital | Recruiting |
Beer-Sheva, Israel, 85101 | |
Rambam Hospital | Recruiting |
Haifa, Israel, 31096 | |
Rabin Medical Center | Recruiting |
Petah Tikva, Israel, 49100 | |
Sheba Medical Center | Recruiting |
Ramat Gan, Israel, 74047 | |
Asaf Harofe Medical Center | Recruiting |
Zrifin, Israel, 60930 | |
Italy | |
Ospedale di Bolzano | Not yet recruiting |
Bolzano, Italy, 39100 | |
Azienda Ulss 6 Euganea- Ospedale Di Camposampiero | Not yet recruiting |
Camposampiero, Italy, 35012 | |
Ospedale Di Carrara | Not yet recruiting |
Carrara, Italy, 54033 | |
ASST -Ospedale Maggiore di Crema | Not yet recruiting |
Crema, Italy, 26013 | |
Azienda Ospedaliera Carlo Poma | Not yet recruiting |
Mantova, Italy, 46100 | |
Azienda ULSS 3 Serenissima, presidio di Mirano | Not yet recruiting |
Mirano, Italy, 30035 | |
PP.OO. di Piombino e Portoferraio Azienda USL Toscana nord ovest | Not yet recruiting |
Piombino, Italy, 57025 | |
Ospedale degli Infermi | Not yet recruiting |
Ponderano, Italy, 13875 | |
Ospedale del Mare ASL Napoli 1 centro | Not yet recruiting |
Ponticelli, Italy, 80147 | |
PO Ospedale S.Anna, ASST Lariana | Not yet recruiting |
San Fermo della Battaglia, Italy, 22042 | |
Korea, Republic of | |
Pusan National University Hospital. | Recruiting |
Busan, Korea, Republic of, 49241 | |
Kyungpook National University Chilgok Hospital | Recruiting |
Daegu, Korea, Republic of, 41404 | |
Keimyung University Dongsan Hospital | Recruiting |
Daegu, Korea, Republic of, 42601 | |
Chungnam National University Hospital | Recruiting |
Daejeon, Korea, Republic of, 35015 | |
National Cancer Center | Recruiting |
Goyang-Si, Korea, Republic of, 10408 | |
Chonnam National University Hospital | Recruiting |
Gwangju, Korea, Republic of, 61469 | |
Seoul National University Bundang Hospital | Recruiting |
Seongnam-si, Korea, Republic of, 13620 | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 03080 | |
Severance Hospital | Recruiting |
Seoul, Korea, Republic of, 03722 | |
Asan Medical Center | Recruiting |
Seoul, Korea, Republic of, 05505 | |
Gangnam Severance Hospital | Recruiting |
Seoul, Korea, Republic of, 06273 | |
Samsung Medical Center | Recruiting |
Seoul, Korea, Republic of, 06351 | |
The Catholic University of Korea, Seoul St. Mary's Hospital | Recruiting |
Seoul, Korea, Republic of, 06591 | |
Ajou University Hospital | Recruiting |
Suwon, Korea, Republic of, 16499 | |
Malaysia | |
Hospital Pulau Pinang | Recruiting |
George Town, Malaysia, 10990 | |
Hospital Kuala Lumpur | Recruiting |
Kuala Lumpur, Malaysia, 50586 | |
University Malaya Medical Centre | Recruiting |
Kuala Lumpur, Malaysia, 59120 | |
Sarawak General Hospital | Recruiting |
Kuching, Malaysia, 93586 | |
Netherlands | |
Renier de Graaf | Not yet recruiting |
Delft, Netherlands, 2625 AD | |
Tergooiziekenhuizen | Not yet recruiting |
Hilversum, Netherlands, 1213XZ | |
Canisius-Wilhelmina Ziekenhuis | Not yet recruiting |
Nijmegen, Netherlands, 6524 KD | |
Elisabeth-TweeSteden Ziekenhuis | Not yet recruiting |
Tilburg, Netherlands, 5022 GC | |
Poland | |
Centrum Onkologii im. Prof. F. Lukaszczyka | Recruiting |
Bydgoszcz, Poland, 85-796 | |
Uniwersyteckie Centrum Kliniczne | Recruiting |
Gdańsk, Poland, 80-214 | |
Szpitale Pomorskie Sp. z o.o. | Recruiting |
Gdynia, Poland, 81-519 | |
Przychodnia Lekarska KOMED Roman Karaszewski | Recruiting |
Konin, Poland, 62-500 | |
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Recruiting |
Lodz, Poland, 93-411 | |
Urologica Praktyka Lekarska Adam Marcheluk | Recruiting |
Siedlce, Poland, 08-110 | |
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Recruiting |
Warszawa, Poland, 02-781 | |
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. | Recruiting |
Warszawa, Poland, 04-073 | |
Specjalistyczna przychodnia lekarska POLIMED | Recruiting |
Wroclaw, Poland, 53-329 | |
Russian Federation | |
Altai Regional Oncology Dispensary | Not yet recruiting |
Barnaul, Russian Federation, 656045 | |
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine | Not yet recruiting |
Chelyabinsk, Russian Federation, 454087 | |
Ivanovo Regional Oncology Dispensary | Not yet recruiting |
Ivanovo, Russian Federation, 153040 | |
Russian Scientific Center of Roentgenoradiology | Not yet recruiting |
Moscow, Russian Federation, 117997 | |
Moscow City Clinical Hospital # 62 | Not yet recruiting |
Moscow, Russian Federation, 125130 | |
Hertzen Oncology Research Institute | Not yet recruiting |
Moscow, Russian Federation, 125284 | |
Privolzhsky District Medical Centre | Not yet recruiting |
Nizhny Novgorod, Russian Federation, 603074 | |
Clinical Oncology Dispensary | Not yet recruiting |
Omsk, Russian Federation, 644013 | |
LLC Novaya Clinica | Not yet recruiting |
Pyatigorsk, Russian Federation, 357500 | |
Pyatigorsk Regional Oncology Dispensary | Not yet recruiting |
Pyatigorsk, Russian Federation, 357502 | |
Private Medical Institution Euromedservice | Not yet recruiting |
Saint Petersburg, Russian Federation, 196603 | |
Leningrad Regional Oncology Dispensary | Not yet recruiting |
Saint-Petersburg, Russian Federation, 191104 | |
Russian Scientific Center of Radiology and Surgical Technologies | Not yet recruiting |
Saint-Petersburg, Russian Federation, 197758 | |
Republican Oncology Dispensary | Not yet recruiting |
Saransk, Russian Federation, 430032 | |
Oncologic Dispensary No.2 | Not yet recruiting |
Sochi, Russian Federation, 354057 | |
Multifunctional clinical medical center 'Medical city' | Not yet recruiting |
Tyumen, Russian Federation, 625041 | |
Bashkir State Medical University | Not yet recruiting |
Ufa, Russian Federation, 450008 | |
Spain | |
Hosp. Univ. A Coruña | Not yet recruiting |
A Coruña, Spain, 15006 | |
Hosp. Univ. Principe de Asturias | Not yet recruiting |
Alcalá De Henares, Madrid, Spain, 28805 | |
Hosp. de La Santa Creu I Sant Pau | Not yet recruiting |
Barcelona, Spain, 08025 | |
Hosp. Clinic I Provincial de Barcelona | Not yet recruiting |
Barcelona, Spain, 08036 | |
Hosp. Univ. Vall D'Hebron | Withdrawn |
Barcelona, Spain, 8035 | |
Hosp. Gral. Univ. de Castellon | Not yet recruiting |
Castellon, Spain, 12004 | |
Hosp. Reina Sofia | Withdrawn |
Córdoba, Spain, 14004 | |
Institut Català D'Oncologia Girona | Not yet recruiting |
Girona, Spain, 17007 | |
Hosp. Univ. de Jaen | Not yet recruiting |
Jaén, Spain, 23007 | |
Hosp. de Jerez de La Frontera | Not yet recruiting |
Jerez de la Frontera, Spain, 11407 | |
Hosp. Arnau de Vilanova de Valencia | Not yet recruiting |
Lleida, Spain, 25198 | |
Hosp. Univ. de La Princesa | Not yet recruiting |
Madrid, Spain, 28006 | |
Hosp. Gral. Univ. Gregorio Marañon | Withdrawn |
Madrid, Spain, 28007 | |
Hosp. Univ. Infanta Leonor | Not yet recruiting |
Madrid, Spain, 28031 | |
Hosp. Univ. Ramon Y Cajal | Not yet recruiting |
Madrid, Spain, 28034 | |
Hosp. Clinico San Carlos | Withdrawn |
Madrid, Spain, 28040 | |
Hosp. Univ. 12 de Octubre | Not yet recruiting |
Madrid, Spain, 28041 | |
Hosp. Univ. La Paz | Not yet recruiting |
Madrid, Spain, 28046 | |
Hosp. Univ. Hm Sanchinarro | Withdrawn |
Madrid, Spain, 28050 | |
Hosp. Univ. Hm Monteprincipe | Not yet recruiting |
Madrid, Spain, 28660 | |
Hosp. Univ. Del Henares | Not yet recruiting |
Madrid, Spain, 28822 | |
Hosp. Virgen de La Victoria | Not yet recruiting |
Málaga, Spain, 29010 | |
Complexo Hosp. Univ. de Ourense | Not yet recruiting |
Ourense, Spain, 32005 | |
Hosp. Univ. Infanta Cristina | Not yet recruiting |
Parla, Madrid, Spain, 28981 | |
Hosp. Quiron Madrid Pozuelo | Withdrawn |
Pozuelo de Alarcon, Spain, 28223 | |
Hosp. Puerto Real | Not yet recruiting |
Puerto Real, Cádiz, Spain, 11510 | |
Hosp. Univ. Sant Joan De Reus | Not yet recruiting |
Reus, Spain, 43204 | |
Corporacio Sanitari Parc Tauli | Not yet recruiting |
Sabadell, Spain, 08208 | |
Hosp. Univ. Marques de Valdecilla | Not yet recruiting |
Santander, Spain, 39008 | |
Hosp. Clinico Univ. de Santiago | Withdrawn |
Santiago de Compostela, Spain, 15706 | |
Hosp. Virgen Del Rocio | Not yet recruiting |
Sevilla, Spain, 41013 | |
Hosp. de Terrassa | Not yet recruiting |
Terrassa, Spain, 08227 | |
Hosp. Clinico Univ. de Valencia | Not yet recruiting |
Valencia, Spain, 46010 | |
Hosp. Univ. I Politecni La Fe | Withdrawn |
Valencia, Spain, 46026 | |
Sweden | |
Skanes universitetssjukhus | Not yet recruiting |
Malmö, Sweden, 20502 | |
Södersjukhuset | Not yet recruiting |
Stockholm, Sweden, 11883 | |
Karolinska Universitetssjukhuset Solna | Not yet recruiting |
Stockholm, Sweden, 17176 | |
Taiwan | |
Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting |
Kaohsiung, Taiwan, 807 | |
Kaohsiung Chang Gung Memorial Hospital | Recruiting |
Kaohsiung, Taiwan, 88301 | |
China Medical University Hospital | Recruiting |
Taichung, Taiwan, 40447 | |
Taichung Veterans General Hospital | Recruiting |
Taichung, Taiwan, 40705 | |
Tungs' Taichung MetroHarbor Hospital | Recruiting |
Taichung, Taiwan, 435 | |
National Cheng Kung University Hospital | Recruiting |
Tainan, Taiwan, 70403 | |
Chi Mei Medical Center - Yong Kang | Recruiting |
Tainan, Taiwan, 710 | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan, 10002 | |
Tri-Service General Hospital | Completed |
Taipei, Taiwan, 11490 | |
Chang Gung Memorial Hospital | Recruiting |
Taoyuan, Taiwan, 33305 | |
Thailand | |
Ramathibodi Hospital | Not yet recruiting |
Bangkok, Thailand, 10400 | |
King Chulalongkorn Memorial Hospital | Not yet recruiting |
Bangkok, Thailand, 10500 | |
Siriraj Hospital | Not yet recruiting |
Bangkok, Thailand, 10700 | |
Turkey | |
Adana Baskent Yuregir Hospital | Not yet recruiting |
Adana, Turkey, 01250 | |
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital | Not yet recruiting |
Ankara, Turkey, 06200 | |
Memorial Ankara Hastanesi | Not yet recruiting |
Ankara, Turkey, 06520 | |
Ankara University Medical Faculty | Not yet recruiting |
Ankara, Turkey, 06590 | |
Ankara Bilkent City Hospital | Not yet recruiting |
Ankara, Turkey, 06800 | |
Akdeniz University Medical Faculty | Not yet recruiting |
Antalya, Turkey, 07070 | |
Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi | Not yet recruiting |
Bursa, Turkey, 16310 | |
Trakya University Medical Faculty | Not yet recruiting |
Edirne, Turkey, 22030 | |
Istanbul University Istanbul Medical Faculty | Not yet recruiting |
Istanbul, Turkey, 34000 | |
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd | Not yet recruiting |
Istanbul, Turkey, 34098 | |
T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi | Not yet recruiting |
İstanbul, Turkey, 34722 | |
Dokuz Eylül University Medical Faculty | Not yet recruiting |
Izmir, Turkey, 35340 | |
Izmir Medical Park Hospital | Not yet recruiting |
Izmir, Turkey, 35580 | |
Manisa Celal Bayar University | Withdrawn |
Manisa, Turkey, 45030 | |
Sakarya University Training and Research Hospital | Not yet recruiting |
Sakarya, Turkey, 54100 | |
Ukraine | |
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' | Recruiting |
Cherkasy, Ukraine, 18009 | |
Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc | Recruiting |
Dnipo, Ukraine, 49005 | |
Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council | Recruiting |
Dnipro, Ukraine, 49100 | |
Ivano-Frankivsk Regional Clinical Hospital | Recruiting |
Ivano-Frankivsk, Ukraine, 76008 | |
Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council | Recruiting |
Kamianske, Ukraine, 51900 | |
Municipal non-profit enterprise 'Regional Center of Oncology' | Recruiting |
Khakhiv, Ukraine, 61070 | |
Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval | Recruiting |
Kharkiv, Ukraine, 61037 | |
Khmelnitckiy regional hospital | Recruiting |
Khmelnytsky, Ukraine, 29000 | |
Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council' | Recruiting |
Kropyvnytskyi, Ukraine, 25011 | |
National Cancer Institute | Not yet recruiting |
Kyiv, Ukraine, 03022 | |
State Institution National Cancer Institute | Withdrawn |
Kyiv, Ukraine, 03022 | |
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center | Recruiting |
Kyiv, Ukraine, 03115 | |
Lviv Clinical Regional Hospital | Recruiting |
Lviv, Ukraine, 79031 | |
ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council' | Recruiting |
Poltava, Ukraine, 36024 | |
Communal Institution of Ternopil Regional Council 'Ternopil Regional Oncology Center' | Withdrawn |
Ternopil, Ukraine, 46023 | |
Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal | Recruiting |
Uzhgorod, Ukraine, 88000 | |
Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council | Recruiting |
Zhytomyr, Ukraine, 10002 | |
United Kingdom | |
Royal Blackburn Hospital | Recruiting |
Blackburn, United Kingdom, BB2 3HH | |
Bristol Haematology and Oncology Centre | Withdrawn |
Bristol, United Kingdom, BS2 8ED | |
Velindre Cancer Centre | Withdrawn |
Cardiff, United Kingdom, CF14 2TL | |
Royal Devon & Exeter Hospital | Withdrawn |
Exeter, United Kingdom, EX2 5DW | |
Guy's Hospital | Not yet recruiting |
Great Maze Pond, United Kingdom, SE1 9RT | |
Royal Marsden Hospital | Not yet recruiting |
London, United Kingdom, SW7 3RP | |
University College London Hospitals | Not yet recruiting |
London, United Kingdom, WC1E 6BT | |
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital | Withdrawn |
Preston, United Kingdom, PR2 9HT |
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Additional Information:
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT03871816 |
Other Study ID Numbers: |
CR108591 64091742PCR0002 ( Other Identifier: Janssen Research & Development, LLC ) |
First Posted: | March 12, 2019 Key Record Dates |
Last Update Posted: | March 29, 2021 |
Last Verified: | March 2021 |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |