Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Condition: Metastatic Prostate Cancer
Intervention:
- Other: Saliva, Blood, or Existing Tissue Sample Collection and Analysis
Purpose: The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair defects in a population of men with metastatic Prostate Cancer (PC) and to use the variants reported to assess biomarker eligibility for niraparib interventional studies.
Study Type: Observational
Clinical Trials Identifier NCT 8-digits: NCT03871816
Sponsor: Janssen Research & Development, LLC
Primary Outcome Measures:
- Measure: Percentage of Participants with 4 or more DNA-repair Defects with Metastatic Prostate Cancer as an Estimate for Prevalence
- Time Frame: Approximately 2.4 years
- Safety Issue:
- Measure: Percentage of Participants who Meet Biomarker Eligibility Criteria for Other Niraparib Interventional Studies
- Time Frame: Approximately 2.4 years
- Safety Issue:
Secondary Outcome Measures:
- Measure: Percentage of Participants with 4 or more DNA-repair 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
- Safety Issue:
- Measure: Percentage of Participants with 1 or more DNA-repair defects with Metastatic Prostate Cancer as an Estimate for Prevalence
- Time Frame: Approximately 2.4 years
- Safety Issue:
Estimated Enrollment: 2540
Study Start Date: April 22, 2019
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Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
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 or blood sample for genomic analysis
Contact:
- Study Contact
- 844-434-4210
Locations:
- Urological Associates of Southern Arizona, P.C.
- Tucson Arizona 85741 United States
- Kaiser Permanente
- Riverside California 92505 United States
- The Urology Center of Colorado
- Denver Colorado 80211 United States
- First Urology
- Jeffersonville Indiana 47130 United States
- Norton Healthcare
- Louisville Kentucky 40202 United States
- Massachusetts General
- Boston Massachusetts 02115 United States
- Barbara Ann Karmanos Cancer Institute
- Detroit Michigan 48201 United States
- Tisch Cancer Institution
- New York New York 10029 United States
- Memorial Sloan Kettering Cancer Center
- New York New York 10065 United States
- Duke Cancer Institute
- Durham North Carolina 27710 United States
- Lancaster Urology
- Lancaster Pennsylvania 17601 United States
- Atlantic Urology Clinics
- Myrtle Beach South Carolina 29572 United States
- MD Anderson Cancer Center
- Houston Texas 77030 United States
- University of Virginia
- Charlottesville Virginia 22908 United States
- INOVA
- Fairfax Virginia 22031 United States
- University of Wisconsin Carbone Cancer Center
- Madison Wisconsin 53792 United States
- Chris O’Brien Lifehouse
- Camperdown 2050 Australia
- St Vincent’s hospital
- Darlinghurst 2010 Australia
- Border Medical Oncology
- East Albury 2640 Australia
- Ashford Cancer Centre
- Kurralta Park 5037 Australia
- Peter MacCallum Cancer Centre
- Melbourne 3000 Australia
- Prince Of Wales Hospital
- Randwick 2031 Australia
- Sydney Adventist Hospital
- Wahroonga 2076 Australia
- Hospital Do Cancer De Barretos – Fundacao Pio Xii
- Barretos 14784-400 Brazil
- PERSONAL – Oncologia de Precisão e Personalizada
- Belo Horizonte 30130-090 Brazil
- Hospital Erasto Gaertner
- Curitiba 81520-060 Brazil
- Pronutrir
- Fortaleza 60 810180 Brazil
- Hospital de Caridade de Ijui
- Ijuí 98700-000 Brazil
- Clínica de Neoplasias Litoral Ltda.
- Itajai 88301-220 Brazil
- Instituto Joinvilense De Hematologia e Oncologia
- Joinville 89201260 Brazil
- Liga Norte Riograndense Contra O Cancer
- Natal 59075-740 Brazil
- Hospital Sao Rafael
- Salvador 41253-190 Brazil
- Instituto de Ensino E Pesquisa Sao Lucas
- Sao Paulo 01236-030 Brazil
- IBCC Instituto Brasileiro de Controle do Cancer
- Sao Paulo 03102-002 Brazil
- British Columbia Cancer Agency (BCCA) – Vancouver Centre
- Vancouver British Columbia V5Z 4E6 Canada
- University Health Network (UHN) Princess Margaret Cancer Centre
- Toronto Ontario M5G 2M9 Canada
- Centre de Recherche du CHUM
- Montreal Quebec H2X 0A9 Canada
- Centre hospitalier universitaire de Québec (CHUQ), L’Hotel-Dieu de Quebéc
- Quebec G1R2J6 Canada
- Soroka Hospital
- Beer-Sheva 85101 Israel
- Rambam Hospital
- Haifa 31096 Israel
- Sheba Medical Center
- Ramat Gan 74047 Israel
- Asaf Harofe Medical Center
- Zrifin 60930 Israel
- Severance Hospital
- Seoul 03722 Korea, Republic of
- Asan Medical Center
- Seoul 05505 Korea, Republic of
- Gangnam Severance Hospital
- Seoul 06273 Korea, Republic of
- Samsung Medical Center
- Seoul 06351 Korea, Republic of
- The Catholic University of Korea, Seoul St. Mary’s Hospital
- Seoul 06591 Korea, Republic of
- Hosp. de La Santa Creu I Sant Pau
- Barcelona 08025 Spain
- Hosp. Univ. Vall D Hebron
- Barcelona 08035 Spain
- Hosp. Clinic I Provincial de Barcelona
- Barcelona 08036 Spain
- Hosp. Reina Sofia
- Córdoba 14004 Spain
- Hosp. Gral. Univ. Gregorio Maranon
- Madrid 28007 Spain
- Hosp. Clinico San Carlos
- Madrid 28040 Spain
- Hosp. Univ. Hm Sanchinarro
- Madrid 28050 Spain
- Hosp. Virgen de La Victoria
- Málaga 29010 Spain
- Hosp. Quiron Madrid Pozuelo
- Pozuelo de Alarcon 28223 Spain
- Hosp. Univ. Marques de Valdecilla
- Santander 39008 Spain
- Hosp. Clinico Univ. de Santiago
- Santiago de Compostela 15706 Spain
- Hosp. Virgen Del Rocio
- Sevilla 41013 Spain
- Hosp. Univ. I Politecni La Fe
- Valencia 46026 Spain
- National Taiwan University Hospital
- Taipei 10002 Taiwan
View trial on ClinicalTrials.gov