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New MRI method could revolutionize prostate cancer screening for High-Risk men

NCT ID NCT05384535

Diagnosis Sponsor: Northwell Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a simpler type of MRI, called biparametric MRI (bpMRI), can improve prostate cancer screening in men at high risk, such as Black men or those with a family history of the disease. The researchers will combine bpMRI with standard PSA blood tests to see if they can detect suspicious lesions earlier and more accurately. The goal is to make screening safer by avoiding contrast dye and reducing unnecessary biopsies.

What this could mean

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

Active substance
Bi-parametric MRI (bpMRI)
What this could lead to
If successful, this could make prostate cancer screening more accurate and safer for high-risk men, reducing unnecessary biopsies.
What could go wrong
This is a small, early-phase study with only 100 participants, so results may not apply to everyone. The MRI might miss some cancers or find false positives.

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 100 people

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

Started

Aug 2022

Expected to finish

Oct 2028

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 55 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: 1. PSA between 1.0 and 2.5 ng/dL 2. High risk for prostate cancer, i.e. Black or they have a first degree relative with history of prostate cancer (father, brother) or specific genetic syndromes i.e. BRCA 1/2, HOX B13, Lynch syndrome, ATM, CHEK2 3. Patient is willing to participated in prostate cancer screening 4. Patient is capable of giving informed consent Exclusion Criteria: 1. Nodularity or firmness of prostate on exam 2. Patient has undergone a prior biopsy or prostate surgery 3. Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels. 4. Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels. 5. Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies 6. Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner 7. The participant cannot tolerate lying flat for the study duration

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Conditions

The condition(s) this trial relates to.

prostate cancer prevention target

As listed by the trial registrant

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

Magnetic resonance imaging Population at risk Prostate cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Cynthia Knauer

    RECRUITING

    Lake Success, New York, 11042, United States

    Contact Email: •••••@•••••

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