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Observational Study for Men at High Genetic Risk for Prostate Cancer

This observational study is looking at men who have specific genetic changes (like in the ATM, BRCA1, BRCA2, or TP53 genes) that are linked to a higher risk of prostate cancer. Researchers want to understand the natural course of prostate health in these men over one year. The goal is to learn more about who is at higher risk for prostate cancer and if these genetic changes, along with family history, can help prevent or treat the disease. You may be able to join if you are a man between 30 and 75 years old, have one of these documented genetic changes, and do not currently have prostate cancer. This study is currently unclear on its status.

Study design
This is an observational study planning to enroll up to 500 participants. It is not testing a specific intervention or drug.
What's involved
Participants will provide blood samples for prostate-specific antigen (PSA) testing. Based on results and age, you may be considered for a biopsy or continued monitoring.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, which looks at the natural history of high genetic risk for prostate cancer, will be measured at one year.

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NCT03805919

Men at High Genetic Risk for Prostate Cancer

Recruiting
Not specifiedAges 30–75Observational
National Cancer Institute (NCI)
~500 participants
Updated 2026-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Natural history of high genetic risk for prostate cancer
Measured over one year

Conditions

Prostatic Neoplasms

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Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Fatima H Karzai, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Anna C Couvillon, C.R.N.P.
[email protected]
(240) 858-3148
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Males between ages 30-75 years old.
Documented germline variant (i.e. pathogenic/likely pathogenic variant) in prostate cancer risk-related gene from a CLIA certified laboratory: BRCA1 and BRCA2, MMR genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) associated with Lynch syndrome, as well as HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51C, RAD51D, BRIP1, or FANC (FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, and FANCM).
Prognosis of \>5 years survival if affected by another cancer
Ability of subject to understand and the willingness to sign a written informed consent document

Exclusion

Prior diagnosis or treatment for prostate cancer
Known contraindication to MRI:
Participants unable to fit through MRI scanner (radiologist discretion)
Allergy to MR contrast agent
Participants with pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic device
Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.

What this trial measures

  • Natural history of high genetic risk for prostate cancerone year

    To follow the natural history of men with known germline variants or likely pathogenic variants in genes that put them at high risk for developing prostate cancer