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