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RECRUITING
NCT03805919

Men at High Genetic Risk for Prostate Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

Background: Research studies have shown that genetic changes and family history may increase a man s risk for prostate cancer. Researchers want to follow the prostate health of men who have specific genetic changes associated with prostate cancer to help them learn more about which men are at higher risk for prostate cancer. Objectives: To study men with specific genetic changes and determine who is at higher risk for getting prostate cancer. To study if certain genetic changes and family history can be used to help prevent or treat prostate cancer. Eligibility: Males between ages 30-75 who have one or more specific genetic changes but without prostate cancer. Design: * This study does not perform genetic testing. All participants must have documented genetic changes and able to provide a copy of the report. * Before enrollment, participants will provide a copy of documented genetic changes and go through a telephone interview to determine eligibility for the study. * On enrollment, participants will have medical and family history review, medication review, physical exam, blood collection for clinical and research testing, and MRI (magnetic resonance imaging) of the prostate. * Every year, participants will repeat the physical exam, medical history, family history, medication review, routine blood tests, including PSA and testosterone. * Every 2 years, participants will repeat all the above plus prostate MRI and blood tests for research. * If, at any time, the physical exam, blood tests or MRI are abnormal, participants may be asked to do a biopsy. * If the biopsy results in prostate cancer, participants will be given counseling on next steps, general treatment recommendations, and then followed with a phone call each year. * Participants may ask to speak with a genetic counselor.

Official title: Natural History Study of Men at High Genetic Risk for Prostate Cancer

Key Details

Gender

MALE

Age Range

30 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2019-03-27

Completion Date

2039-01-01

Last Updated

2026-01-08

Healthy Volunteers

No

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States