RecruitingNCT03805919

Men at High Genetic Risk for Prostate Cancer

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


Sponsor

National Cancer Institute (NCI)

Enrollment

500 participants

Start Date

Mar 27, 2019

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is enrolling men who carry certain inherited gene mutations that significantly raise their risk of developing prostate cancer, with the goal of monitoring them closely and detecting prostate cancer early if it develops. **You may be eligible if...** - You are a male between 30 and 75 years old - You have a confirmed genetic mutation in a prostate cancer risk gene (such as BRCA1, BRCA2, ATM, or others associated with Lynch syndrome or similar hereditary conditions), confirmed by a certified lab - You have not previously been diagnosed with or treated for prostate cancer - Your life expectancy is more than 5 years **You may NOT be eligible if...** - You have already been diagnosed with prostate cancer - You have a condition that prevents you from having an MRI scan (such as certain metal implants) - You do not carry one of the qualifying genetic mutations Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT03805919


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