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

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 : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Metastatic Prostate Cancer Other: Saliva, Blood, or Existing Tissue Sample Collection and Analysis

Study Design
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Study Type : Observational
Estimated Enrollment : 2540 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 : August 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Participants with Metastatic Prostate Cancer
Participants with metastatic prostate Cancer (PC) will be evaluated for the prevalence of positive results of DNA-repair defects and will be assessed for biomarker eligibility status for niraparib interventional studies. Participants will be consented to saliva, blood, or existing tissue sample testing for the presence or absence of DNA repair defects.
 Other: Saliva, Blood, or Existing Tissue Sample Collection and Analysis
Saliva or blood sample (or both) or existing tissue sample analysis will be collected from the participants with metastatic PC for genetic testing to determine if DNA-repair defects are present.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Percentage of participants with 4 or more Deoxyribonucleic acid (DNA)-repair defects with metastatic Prostate Cancer (PC) as an estimate for prevalence will be assessed. A saliva or blood sample (or both) or existing tissue sample will be collected for genetic testing to determine if DNA-repair defects are present. The retrieval of archived prostate or metastatic tissue samples is optional.

  2. 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 :
  1. 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 ]
    Percentage of participants with 4 or more DNA-repair defects with mCRPC and HSPC as an estimate for prevalence will be assessed. A saliva or blood sample (or both) or existing tissue samples will be collected for genetic testing to determine if DNA-repair defects are present.

  2. 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 ]
    Percentage of participants with 1 or more DNA-repair defects with metastatic PC as an estimate for prevalence will be assessed. A saliva or blood sample (or both) or existing tissue samples will be collected for genetic testing to determine if DNA-repair defects are present.


Eligibility Criteria
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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 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 or blood sample for genomic analysis
Contacts and Locations
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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
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Additional Information:
To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

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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: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases