Official Title
Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Brief Title
A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Protocol ID
NCT03871816
Lead Sponsor
Janssen Research & Development, LLC
Brief Summary
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.
Study Period
-
Enrollment Count
14,532 participants
Eligibility 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, 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
Filters
Metastatic Prostate Cancer
COMPLETED
ADULT
OLDER_ADULT