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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	number of patients with a BRCA2 mutation who are diagnosed with prostate cancer	Up to 3 years

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Preston Sprenkle, MD, Yale University

Study record dates

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: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 1402013376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO