Prostate Cancer Screening in Men With Germline BRCA2 Mutations

January 21, 2021 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Study participants will be identified because of their BRCA2 mutation that places them at increased risk for developing prostate cancer. Because this is a pre-selected high-risk population, and our goal is to establish the incidence of cancer and association of risk factors with developing disease, all men ≥30 years of age, able to give informed consent, and with at least a 5-10 year life expectancy will have PSA testing, prostate examination, Pelvic MRI, and Artemis fusion prostate biopsy.

Men identified to have prostate cancer will be treated according to current standards of care. Treatment for prostate cancer at the Yale Cancer Center is largely based on clinical risk; options include, but are not limited to, active surveillance for appropriate men with low risk disease, treatment with curative intent for men with localized intermediate and high risk prostate cancer, and systemic therapy for men with metastatic disease.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Preston Sprenkle, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

May 30, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1402013376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe