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

NCT03871816 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14532

Last updated 2023-12-11

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2022-10-30
Completion
2022-11-22

Countries

  • United States
  • Argentina
  • Australia
  • Belarus
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Malaysia
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03871816 on ClinicalTrials.gov