Prostate Cancer Screening in Men With Germline BRCA2 Mutations

NCT ID: NCT02154672

Last Updated: 2021-02-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2019-11-01

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Preston Sprenkle, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1402013376

Identifier Type: -

Identifier Source: org_study_id

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