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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Metastatic Prostate Cancer

Treatments: Other: Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis

Study type: Observational

Funder types: Industry

Identifiers

NCT03871816

CR108591

64091742PCR0002 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 14,532 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

14,532 participants in 1 patient group

Participants with Metastatic Prostate Cancer

Description:

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.

Treatment:

Other: Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis