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OpenTrials
Completed

NCT Number: NCT02154672

Prostate Cancer Screening in Men With Germline BRCA2 Mutations

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

30 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

Yale University

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • If a man has received or is currently receiving treatment for prostate cancer

Treatment and study plan

Primary outcomes

  1. Number of Prostate Cancer Patients With BRCA2 Mutation Carriers

    Time frame: Up to 3 years

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 3, 2014
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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