Men at High Genetic Risk for Prostate Cancer

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03805919
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Study Details

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....

Key Dates

Start date
Mar 27, 2019
Status verified
Dec 2025
Primary completion
Jan 1, 2029
Completion
Jan 1, 2039

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Cohort 1
    Participants with germline pathogenic or likely pathogenic variants in prostate cancer-related risk genes

Primary Outcome Measure

Natural history of high genetic risk for prostate cancer [ Time Frame: one year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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