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Prostate Cancer Screening in Men With Germline BRCA2 Mutations

Completed
Conditions
Prostate Cancer
Registration Number
NCT02154672
Lead Sponsor
Yale University
Brief Summary

The purpose of this study is to determine the incidence of prostate cancer in men with the BRCa2 gene mutation as an independent indicator for prostate cancer screening.

Detailed Description

This is a cohort screening study to prospectively identify the incidence of prostate cancer in a population of BRCA2 carriers. All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing.

Standard of care screening at the Yale Cancer Center for men with a normal prostate cancer risk consists of a PSA test and prostate physical examination beginning at age 50 years and if either is abnormal an MRI of the prostate followed by Fusion-targeted biopsy of the prostate is performed.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
1
Inclusion Criteria
  • All men ≥30 years of age with at least a ten-year life expectancy
  • A known BRCA2 mutation
  • Ability to have an MRI
  • Able to give informed consent will be approached to participate in the study
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Exclusion Criteria
  • If a man has received or is currently receiving treatment for prostate cancer
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of Prostate Cancer Patients With BRCA2 Mutation CarriersUp to 3 years

number of patients with a BRCA2 mutation who are diagnosed with prostate cancer

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Yale University

🇺🇸

New Haven, Connecticut, United States

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