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Gene test + MRI may catch deadly prostate cancer earlier

NCT ID NCT06398639

Diagnosis Sponsor: Adam S. Kibel, MD 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new way to screen for aggressive prostate cancer. Researchers will give 1,500 men aged 40-69 a genetic risk score, a PSA blood test, and a special MRI. The goal is to see if combining genetic risk with MRI can better identify high-grade cancers that could be fatal, while avoiding overdiagnosis of low-risk disease. Participants will be followed based on their risk level and test results.

What this could mean

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

Active substance
Polygenic Risk Score (genetic test) plus multiparametric MRI
What this could lead to
If successful, this could lead to a more accurate screening method that catches dangerous prostate cancers early while avoiding unnecessary biopsies.
What could go wrong
This is an early-stage observational study, not a treatment trial. The genetic test and MRI may not improve detection enough to change current practice, and results may not apply to all ethnic groups.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,500 people

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

Started

May 2024

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

40 to 69 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * They must have the ability to understand and the willingness to sign a written information consent document. * Estimated life expectancy of greater than 10 years. * No history of prostate cancer. * Participants must be between 40-69 years of age. This is the age at which screening for prostate cancer is recommended. This is due to younger patients not being at risk for the disease and older patients not benefiting from diagnosis. * No biopsy for prostate cancer within the past 5 years. * No prostate MRI within the past 5 years. Exclusion Criteria: * Unwillingness to sign the informed consent form. * Contraindication to biopsy such as uncorrectable bleeding or coagulation disorder. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery. * Unable to undergo an MRI.

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Conditions

The condition(s) this trial relates to.

Genetic Risk Score prostate cancer

As listed by the trial registrant

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

Polygenic risk score Prostate cancer

How to take part

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

  1. The places running it

    5 sites. 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

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02155, United States

  • Howard University Hospital

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20060, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • National Cancer Institute

    NOT_YET_RECRUITING

    Bethesda, Maryland, 20814, United States

  • Walter Reed National Military Medical Center

    NOT_YET_RECRUITING

    Bethesda, Maryland, 20814, United States

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