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

  • End date
    Sep 16, 2023
  • participants needed
  • sponsor
    Janssen Research & Development, LLC
Updated on 8 January 2021
The Medical Research Network, LLC
Primary Contact
Chesapeake Urology Associates (9.3 mi away) Contact
+389 other location


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.

Treatment Saliva, Blood, or Existing Tissue Sample Collection and Analysis, Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis
Clinical Study IdentifierNCT03871816
SponsorJanssen Research & Development, LLC
Last Modified on8 January 2021

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have Metastatic Prostate Cancer?
Do you have any of these conditions: Metastatic Prostate Cancer or Prostate Cancer Metastatic?
Do you have any of these conditions: Prostate Cancer Metastatic or Metastatic Prostate Cancer?
Do you have any of these conditions: Metastatic Prostate Cancer or Prostate Cancer Metastatic?
Do you have any of these conditions: Metastatic Prostate Cancer or Prostate Cancer Metastatic?
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
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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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