Biomarker 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 16 October 2022


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.

Condition Metastatic Prostate Cancer
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 on16 October 2022


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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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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