Actively Recruiting
Men at High Genetic Risk for Prostate Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-04-24
500
Participants Needed
1
Research Sites
1031 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Men at High Genetic Risk for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males between ages 30-75 years old
- Documented germline variant (pathogenic or likely pathogenic) in prostate cancer risk-related genes from a certified laboratory
- Expected survival greater than 5 years if affected by another cancer
- Ability and willingness to provide informed consent
You will not qualify if you...
- Prior diagnosis or treatment for prostate cancer
- Known inability to undergo MRI (due to size, allergy to contrast agent, or implanted devices like pacemakers or clips)
- Active medical or psychological conditions that increase risk or prevent informed consent, as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Anna C Couvillon, C.R.N.P.
CONTACT
F
Fatima H Karzai, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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