A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Participants with Metastatic Prostate Cancer | Participants with metastatic prostate Cancer (PC) will be evaluated for the prevalence of DNA-repair gene defects (DRDs) and will be assessed for biomarker eligibility status for niraparib interventional studies. Participants will be consented to saliva, blood, and/or archival tumor tissue testing for the presence or absence of DNA-repair gene defects. |
|
More Details
- Status
- Completed
- Sponsor
- Janssen Research & Development, LLC