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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

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

ArmDescriptionAssigned 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.
  • Other: Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis
    Saliva, blood, and/or archival tumor tissue will be collected from the participants with metastatic PC for genomic testing to confirm DRD status.

More Details

Status
Completed
Sponsor
Janssen Research & Development, LLC

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.