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Can genes predict prostate cancer? new study follows High-Risk men

NCT ID NCT03805919

Knowledge-focused Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 18 times

Summary

This study tracks 500 men aged 30-75 who have specific genetic changes linked to prostate cancer but have not been diagnosed. Researchers will monitor their health over time using yearly exams, blood tests, and MRI scans to understand how these genes affect cancer risk. The goal is to improve early detection and prevention strategies for those at highest genetic risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help identify which genetic changes most increase prostate cancer risk and improve screening guidelines.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to direct benefits for participants and results may take years to emerge.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2019

Expected to finish

Jan 2039

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Men with a documented germline variant in prostate cancer risk-related gene from a CLIA certified laboratory

Ages

30 to 75 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Colorectal Neoplasms, Hereditary Nonpolyposis prostate neoplasm prostate cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostatic neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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