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

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


Lead Sponsor: Janssen Research & Development, LLC

Source Janssen Research & Development, LLC
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.

Overall Status Recruiting
Start Date April 22, 2019
Completion Date January 31, 2024
Primary Completion Date July 26, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Prostate Cancer as an Estimate for Prevalence Approximately 2.4 years
Percentage of Participants who Meet Biomarker Eligibility Criteria for Other Niraparib Interventional Studies Approximately 2.4 years
Secondary Outcome
Measure Time Frame
Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and with Metastatic Hormone Sensitive PC (HSPC) as an Estimate for Prevalence Approximately 2.4 years
Percentage of Participants with 1 or more DNA-repair gene defects with Metastatic Prostate Cancer as an Estimate for Prevalence Approximately 2.4 years
Enrollment 2540

Intervention Type: Other

Intervention Name: Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis

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

Arm Group Label: Participants with Metastatic Prostate Cancer


Sampling Method: Probability Sample


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

Gender: Male

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Overall Contact

Last Name: Study Contact

Phone: 844-434-4210

Email: [email protected]

Facility: Status:
Urology Centers Of Alabama | Homewood, Alabama, 35209, United States Not yet recruiting
Southern Cancer Center, PC | Mobile, Alabama, 36608, United States Recruiting
Arizona Oncology Associates, PC - HAL | Phoenix, Arizona, 85016, United States Recruiting
Mayo Clinic | Phoenix, Arizona, 85054, United States Recruiting
Southern Arizona VA Healthcare System | Tucson, Arizona, 85723, United States Withdrawn
Urological Associates of Southern Arizona, P.C. | Tucson, Arizona, 85741, United States Recruiting
Arkansas Urology | Little Rock, Arkansas, 72211, United States Recruiting
University of Southern California | Los Angeles, California, 90089, United States Withdrawn
Kaiser Permanente | Riverside, California, 92505, United States Recruiting
San Bernardino Urological Associates | San Bernardino, California, 92506, United States Recruiting
Sansum Clinic Pharm | Santa Barbara, California, 93105, United States Recruiting
The Urology Center of Colorado | Denver, Colorado, 80211, United States Recruiting
UC Health Cancer Center | Fort Collins, Colorado, 80528, United States Withdrawn
Foothills Urology - Golden Off | Golden, Colorado, 80401, United States Recruiting
Advanced Urology Institute | Daytona Beach, Florida, 32114, United States Recruiting
University of Florida | Jacksonville, Florida, 33209, United States Withdrawn
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group | Miami, Florida, 33176, United States Recruiting
Woodlands Medical Specialists, PA | Pensacola, Florida, 32503, United States Recruiting
Affiliated Oncologists, LLC | Chicago Ridge, Illinois, 60415, United States Recruiting
First Urology | Jeffersonville, Indiana, 47130, United States Recruiting
Norton Healthcare | Louisville, Kentucky, 40202, United States Completed
Maryland Oncology Hematology, PA | Columbia, Maryland, 21044, United States Recruiting
Chesapeake Urology Associates | Towson, Maryland, 21204, United States Recruiting
Massachusetts General | Boston, Massachusetts, 02115, United States Withdrawn
Beth Israel Deaconess Hospital Plymouth, Jordan Club Cancer Center | Plymouth, Massachusetts, 02360, United States Recruiting
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, 48201, United States Recruiting
Michigan Institute of Urology | Troy, Michigan, 48084, United States Recruiting
Minnesota Oncology Hematology, P.A. | Minneapolis, Minnesota, 55404, United States Recruiting
Adult Pediatric Urology & Urogynecology, P.C | Omaha, Nebraska, 68114, United States Recruiting
GU Research Network | Omaha, Nebraska, 68130, United States Recruiting
Nebraska Cancer Specialists | Omaha, Nebraska, 68130, United States Recruiting
New York Oncology Hematology | Albany, New York, 12208, United States Recruiting
Montefiore Medical Center | Bronx, New York, 10461, United States Recruiting
Northwell Health Cancer Institute | Lake Success, New York, 11042, United States Withdrawn
Tisch Cancer Institution | New York, New York, 10029, United States Not yet recruiting
Memorial Sloan Kettering Cancer Center | New York, New York, 10065, United States Withdrawn
Upstate Cancer Center | Syracuse, New York, 13210, United States Not yet recruiting
Duke Cancer Institute | Durham, North Carolina, 27710, United States Withdrawn
Willamette Valley Cancer Institute and Research Center | Eugene, Oregon, 97401, United States Recruiting
Northwest Cancer Specialists PC | Portland, Oregon, 97213-2982, United States Recruiting
Oregon Urology Institute | Springfield, Oregon, 97477, United States Not yet recruiting
Centers for Advanced Urology, LLC; d/b/a MidLantic Urology | Bala-Cynwyd, Pennsylvania, 19004, United States Recruiting
Consultants in Medical Oncology and Hematology, P.C. - Abington | Horsham, Pennsylvania, 19044, United States Recruiting
Lancaster Urology | Lancaster, Pennsylvania, 17601, United States Recruiting
Thomas Jefferson University | Philadelphia, Pennsylvania, 19107, United States Withdrawn
University of Pittsburgh Medical Center (UPMC) | Pittsburgh, Pennsylvania, 15232, United States Recruiting
Prisma Health | Greenville, South Carolina, 29615, United States Recruiting
Atlantic Urology Clinics | Myrtle Beach, South Carolina, 29572, United States Recruiting
Texas Onc. | Abilene, Texas, 79606, United States Recruiting
Texas Oncology-Amarillo | Amarillo, Texas, 79106, United States Recruiting
Texas Oncology-Austin | Austin, Texas, 78731, United States Recruiting
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center | Beaumont, Texas, 77702-1449, United States Recruiting
Methodist Dallas Medical Center | Dallas, Texas, 75203, United States Recruiting
Texas Oncology-Denton South | Denton, Texas, 76201, United States Recruiting
Texas Oncology, P.A. - Flower Mound | Flower Mound, Texas, 75028, United States Recruiting
Texas Oncology-Fort Worth Cancer Center | Fort Worth, Texas, 76104, United States Recruiting
Houston Metro Urology | Houston, Texas, 77027, United States Recruiting
MD Anderson Cancer Center | Houston, Texas, 77030, United States Recruiting
Texas Oncology - Willowbrook | Houston, Texas, 77070, United States Recruiting
Texas Oncology P.A. | Longview, Texas, 75601, United States Recruiting
Texas Oncology P.A. | McAllen, Texas, 78503, United States Recruiting
Texas Oncology-Mesquite | Mesquite, Texas, 75150, United States Recruiting
Texas Oncology-Midland Allison Cancer Center | Midland, Texas, 79701, United States Recruiting
Texas Oncology, P.A. - Paris | Paris, Texas, 75460, United States Recruiting
Texas Oncology P A | Plano, Texas, 75075, United States Recruiting
Texas Oncology P.A. | Plano, Texas, 75093, United States Recruiting
University of Texas at San Antonio | San Antonio, Texas, 78217, United States Recruiting
Texas Oncology -Waco | Waco, Texas, 76712, United States Recruiting
Texas Oncology Deke Slayton Cancer Center | Webster, Texas, 77598, United States Recruiting
Texas Oncology P.A. | Wichita Falls, Texas, 76310, United States Recruiting
University of Virginia | Charlottesville, Virginia, 22908, United States Recruiting
INOVA | Fairfax, Virginia, 22031, United States Recruiting
Virginia Cancer Specialists | Leesburg, Virginia, 20176, United States Recruiting
Virginia Oncology Asc | Norfolk, Virginia, 23502, United States Not yet recruiting
Urology of Virginia, PLCC | Virginia Beach, Virginia, 23462, United States Recruiting
University of Washington School of Medicine | Seattle, Washington, 98195, United States Withdrawn
Northwest Medical Specialists | Tacoma, Washington, 98405, United States Recruiting
Building Oncology Research | Janesville, Wisconsin, 53548, United States Recruiting
University of Wisconsin Carbone Cancer Center | Madison, Wisconsin, 53792, United States Recruiting
Hospital Aleman | Buenos Aires, C1118AAT, Argentina Recruiting
Fundación CENIT para la Investigación en Neurociencias | Capital Federal, CP 1125, Argentina Recruiting
CEMIC Saavedra | Ciudad Autonoma de Buenos Aires, C1431FWN, Argentina Recruiting
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Cordoba, 5000, Argentina Recruiting
Hospital Privado - Centro Medico de Cordoba | Cordoba, X5016KEH, Argentina Recruiting
Instituto de Investigaciones Clinicas Mar del Plata | Mar Del Plata, B7600FZN, Argentina Withdrawn
Hospital Privado de Comunidad | Mar Del Plata, B7602CBM, Argentina Not yet recruiting
Centro de Investigacion Pergamino SA | Pergamino, B2700CPM, Argentina Not yet recruiting
Sanatorio Parque | Rosario, S2000SDV, Argentina Recruiting
ARS Médica | San Salvador De Jujuy, Y4600AFW, Argentina Recruiting
Royal Adelaide Hospital | Adelaide, 5116, Australia Withdrawn
Pindara Private Hospital | Benowa, 4217, Australia Not yet recruiting
Sunshine Coast University Hospital | Birtinya, 4575, Australia Not yet recruiting
Princess Alexandra Hospital | Brisbane, 4102, Australia Not yet recruiting
Chris O'Brien Lifehouse | Camperdown, 2050, Australia Not yet recruiting
St Vincent's hospital | Darlinghurst, 2010, Australia Recruiting
Border Medical Oncology | East Albury, 2640, Australia Recruiting
Royal Hobart Hospital | Hobart, 7000, Australia Not yet recruiting
Ashford Cancer Centre | Kurralta Park, 5037, Australia Recruiting
Cabrini Health | Malvern, 3144, Australia Withdrawn
Peter MacCallum Cancer Centre | Melbourne, 3000, Australia Not yet recruiting
Fiona Stanley Hospital | Murdoch, 6150, Australia Not yet recruiting
Hollywood Private Hospital | Nedlands, 6009, Australia Withdrawn
Macquarie University Hospital | North Ryde, 2109, Australia Recruiting
Prince Of Wales Hospital | Randwick, 2031, Australia Not yet recruiting
Sydney Adventist Hospital | Wahroonga, 2076, Australia Not yet recruiting
Wollongong Private Hospital | Wollongong, 2500, Australia Withdrawn
Hospital Do Cancer De Barretos - Fundacao Pio Xii | Barretos, 14784-400, Brazil Recruiting
PERSONAL - Oncologia de Precisão e Personalizada | Belo Horizonte, 30130-090, Brazil Recruiting
Hospital Sírio Libanes Unidade Brasilia | Brasilia, 70200-730, Brazil Recruiting
CIONC - Centro Integrado de Oncologia de Curitiba | Curitiba, 80810-050, Brazil Recruiting
Hospital Erasto Gaertner | Curitiba, 81520-060, Brazil Recruiting
Pronutrir | Fortaleza, 60 810180, Brazil Recruiting
Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás | Goiânia, 74605-070, Brazil Recruiting
Hospital de Caridade de Ijui | Ijuí, 98700-000, Brazil Recruiting
Clínica de Neoplasias Litoral Ltda. | Itajai, 88301-220, Brazil Recruiting
Instituto Joinvilense De Hematologia e Oncologia | Joinville, 89201260, Brazil Recruiting
Centro de Tratamento de câncer Medradius | Maceió, 57052-765, Brazil Recruiting
Liga Norte Riograndense Contra O Cancer | Natal, 59075-740, Brazil Recruiting
Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre, 90020-090, Brazil Recruiting
Hospital Universitário Pedro Ernesto | Rio de Janeiro, 20551-030, Brazil Recruiting
Instituto COI de Pesquisa, Educacao e Gestao | Rio de Janeiro, 22793-080, Brazil Withdrawn
Instituto COI de Pesquisa, Educacao e Gestao | Rio de Janeiro, 22793-080, Brazil Recruiting
Hospital Sao Rafael | Salvador, 41253-190, Brazil Recruiting
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia | Santo André, 09060-650, Brazil Recruiting
Santa Casa de Misericordia de São Paulo | Sao Paulo, 01221-020, Brazil Recruiting
Instituto de Ensino E Pesquisa Sao Lucas | Sao Paulo, 01236-030, Brazil Recruiting
IBCC Instituto Brasileiro de Controle do Cancer | Sao Paulo, 03102-002, Brazil Recruiting
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado | Sorocaba, 18030-075, Brazil Recruiting
Fundação Antônio Prudente - A.C. Camargo Cancer Center | São Paulo, 01509-900, Brazil Recruiting
Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO | São Paulo, 04039-004, Brazil Recruiting
Hospital Israelita Albert Einstein | São Paulo, 05651-900, Brazil Withdrawn
Instituto do Cancer De Tres Lagoas | Três Lagoas, 79601-001, Brazil Recruiting
Southern Alberta Institute of Urology / Prostate Cancer Centre | Calgary, Alberta, T2V 1P9, Canada Recruiting
British Columbia Cancer Agency (BCCA) - Vancouver Centre | Vancouver, British Columbia, V5Z 4E6, Canada Recruiting
British Columbia Cancer Agency - Vancouver Island Centre | Victoria, British Columbia, V8R 6V5, Canada Recruiting
McMaster Institute of Urology | Hamilton, Ontario, L8N 4A6, Canada Not yet recruiting
Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre) | Kingston, Ontario, K7L 3N6, Canada Recruiting
University Health Network (UHN) Princess Margaret Cancer Centre | Toronto, Ontario, M5G 2M9, Canada Recruiting
Centre de Recherche du CHUM | Montreal, Quebec, H2X 0A9, Canada Recruiting
Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc | Quebec, G1R2J6, Canada Recruiting
Institut Sainte Catherine | Avignon, 84918, France Recruiting
Centre Hospitalier Regional Universitaire Besancon | Besançon, 25030, France Not yet recruiting
Institut Bergonié | Bordeaux, 33000, France Not yet recruiting
Centre Francois Baclesse | Caen, 14000, France Withdrawn
Centre Jean Perrin | Clermont Ferrand, 63011, France Not yet recruiting
Centre Leon Bérard | Lyon, 69008, France Not yet recruiting
Polyclinique de Gentilly | Nancy, 54100, France Not yet recruiting
Centre Antoine Lacassagne | Nice, 6189, France Not yet recruiting
Hopital Europeen Georges-Pompidou | Paris Cedex 15, 75908, France Not yet recruiting
Hôpital Saint Louis | Paris, 75010, France Withdrawn
Institut Jean Godinot | Reims, 51726, France Withdrawn
Institut de Cancérologie de l'Ouest (ICO) | Saint Herblain, 44805, France Not yet recruiting
HIA Begin | Saint Mande, 94163, France Recruiting
Hôpitaux Universitaire de Strasbourg -CHU | Strasbourg, 67091, France Not yet recruiting
Institut Gustave Roussy | Villejuif, 94805, France Not yet recruiting
Soroka Hospital | Beer-Sheva, 85101, Israel Recruiting
Rambam Hospital | Haifa, 31096, Israel Recruiting
Rabin Medical Center | Petah Tikva, 49100, Israel Recruiting
Sheba Medical Center | Ramat Gan, 74047, Israel Recruiting
Asaf Harofe Medical Center | Zrifin, 60930, Israel Recruiting
Pusan National University Hospital. | Busan, 49241, Korea, Republic of Recruiting
Kyungpook National University Chilgok Hospital | Daegu, 41404, Korea, Republic of Recruiting
Keimyung University Dongsan Hospital | Daegu, 42601, Korea, Republic of Recruiting
Chungnam National University Hospital | Daejeon, 35015, Korea, Republic of Recruiting
National Cancer Center | Goyang-Si, 10408, Korea, Republic of Not yet recruiting
Chonnam National University Hospital | Gwangju, 61469, Korea, Republic of Recruiting
Seoul National University Bundang Hospital | Seongnam-si, 13620, Korea, Republic of Recruiting
Seoul National University Hospital | Seoul, 03080, Korea, Republic of Recruiting
Severance Hospital | Seoul, 03722, Korea, Republic of Recruiting
Asan Medical Center | Seoul, 05505, Korea, Republic of Recruiting
Gangnam Severance Hospital | Seoul, 06273, Korea, Republic of Recruiting
Samsung Medical Center | Seoul, 06351, Korea, Republic of Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul, 06591, Korea, Republic of Recruiting
Ajou University Hospital | Suwon, 16499, Korea, Republic of Recruiting
Hospital Pulau Pinang | George Town, 10990, Malaysia Not yet recruiting
Hospital Kuala Lumpur | Kuala Lumpur, 50586, Malaysia Not yet recruiting
University Malaya Medical Centre | Kuala Lumpur, 59120, Malaysia Not yet recruiting
Sarawak General Hospital | Kuching, 93586, Malaysia Not yet recruiting
Centrum Onkologii im. Prof. F. Lukaszczyka | Bydgoszcz, 85-796, Poland Not yet recruiting
Uniwersyteckie Centrum Kliniczne | Gdańsk, 80-214, Poland Not yet recruiting
Szpitale Pomorskie Sp. z o.o. | Gdynia, 81-519, Poland Not yet recruiting
Przychodnia Lekarska KOMED Roman Karaszewski | Konin, 62-500, Poland Not yet recruiting
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi | Lodz, 93-509, Poland Not yet recruiting
Urologica Praktyka Lekarska Adam Marcheluk | Siedlce, 08-110, Poland Not yet recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Warszawa, 02-781, Poland Not yet recruiting
Specjalistyczna przychodnia lekarska POLIMED | Wroclaw, 53-329, Poland Not yet recruiting
Hosp. de La Santa Creu I Sant Pau | Barcelona, 08025, Spain Withdrawn
Hosp. Clinic I Provincial de Barcelona | Barcelona, 08036, Spain Withdrawn
Hosp. Univ. Vall D'Hebron | Barcelona, 8035, Spain Withdrawn
Hosp. Reina Sofia | Córdoba, 14004, Spain Withdrawn
Hosp. Gral. Univ. Gregorio Marañon | Madrid, 28007, Spain Withdrawn
Hosp. Clinico San Carlos | Madrid, 28040, Spain Withdrawn
Hosp. Univ. Hm Sanchinarro | Madrid, 28050, Spain Withdrawn
Hosp. Virgen de La Victoria | Málaga, 29010, Spain Withdrawn
Hosp. Quiron Madrid Pozuelo | Pozuelo de Alarcon, 28223, Spain Withdrawn
Hosp. Univ. Marques de Valdecilla | Santander, 39008, Spain Withdrawn
Hosp. Clinico Univ. de Santiago | Santiago de Compostela, 15706, Spain Withdrawn
Hosp. Virgen Del Rocio | Sevilla, 41013, Spain Withdrawn
Hosp. Univ. I Politecni La Fe | Valencia, 46026, Spain Withdrawn
Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung, 807, Taiwan Recruiting
Kaohsiung Chang Gung Memorial Hospital | Kaohsiung, 88301, Taiwan Recruiting
China Medical University Hospital | Taichung, 40447, Taiwan Recruiting
Taichung Veterans General Hospital | Taichung, 40705, Taiwan Recruiting
Tungs' Taichung MetroHarbor Hospital | Taichung, 435, Taiwan Recruiting
National Cheng Kung University Hospital | Tainan, 70403, Taiwan Recruiting
Chi Mei Medical Center - Yong Kang | Tainan, 710, Taiwan Recruiting
National Taiwan University Hospital | Taipei, 10002, Taiwan Recruiting
Tri-Service General Hospital | Taipei, 11490, Taiwan Recruiting
Chang Gung Memorial Hospital | Taoyuan, 33305, Taiwan Recruiting
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' | Cherkasy, 18009, Ukraine Recruiting
Dnipropetrovsk State Medical Academy, Dnipropetrovk State Clinical Hospital NA Mechnikov I.I. | Dnipo, 49005, Ukraine Recruiting
Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council | Dnipro, 49100, Ukraine Recruiting
Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk, 76008, Ukraine Recruiting
Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council | Kamianske, 51900, Ukraine Recruiting
Municipal non-profit enterprise 'Regional Center of Oncology' | Khakhiv, 61070, Ukraine Recruiting
Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval | Kharkiv, 61037, Ukraine Recruiting
Khmelnitckiy regional hospital | Khmelnytsky, 29000, Ukraine Recruiting
Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council' | Kropyvnytskyi, 25011, Ukraine Recruiting
State Institution National Cancer Institute | Kyiv, 03022, Ukraine Withdrawn
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center | Kyiv, 03115, Ukraine Recruiting
Lviv Clinical Regional Hospital | Lviv, 79031, Ukraine Recruiting
ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council' | Poltava, 36024, Ukraine Recruiting
Communal Institution of Ternopil Regional Council 'Ternopil Regional Oncology Center' | Ternopil, 46023, Ukraine Withdrawn
Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal | Uzhgorod, 88000, Ukraine Recruiting
Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council | Zhytomyr, 10002, Ukraine Recruiting
Royal Blackburn Hospital | Blackburn, BB2 3HH, United Kingdom Not yet recruiting
Bristol Haematology and Oncology Centre | Bristol, BS2 8ED, United Kingdom Not yet recruiting
Velindre Cancer Centre | Cardiff, CF14 2TL, United Kingdom Not yet recruiting
Royal Devon & Exeter Hospital | Exeter, EX2 5DW, United Kingdom Withdrawn
Royal Marsden Hospital | London, SW7 3RP, United Kingdom Not yet recruiting
University College London Hospitals | London, WC1E 6BT, United Kingdom Not yet recruiting
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital | Preston, PR2 9HT, United Kingdom Not yet recruiting
Location Countries







Korea, Republic of






United Kingdom

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Participants with Metastatic Prostate Cancer

Description: 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.

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov