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New ultrasound could rival MRI for prostate cancer detection

NCT ID NCT06626022

Diagnosis Sponsor: University of Alberta 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 3 times

Summary

This phase 3 trial compares a new high-resolution micro-ultrasound to the standard MRI for detecting significant prostate cancer in men aged 50-70 with elevated PSA. About 1,284 participants will be randomly assigned to one imaging method before deciding on biopsy. The goal is to see if the ultrasound is as good as MRI, potentially offering a faster, cheaper screening option.

What this could mean

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

Active substance
micro-ultrasound (ExactVu) and MRI
What this could lead to
If successful, micro-ultrasound could become a more accessible and cheaper alternative to MRI for prostate cancer screening, potentially improving early detection rates.
What could go wrong
This is a non-inferiority trial, so micro-ultrasound may prove less effective than MRI. The study is still recruiting, and results are not yet available.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,284 people

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

Started

May 2025

Expected to finish

Nov 2029

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

50 to 70 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: 1. Male sex; 2. Age 50-70; 3. PSA 3-20 and/or abnormal DRE; 4. Biopsy naïve. Exclusion Criteria: 1. Prior personal history of prostate cancer; 2. Prior prostate imaging using microUS or MRI; 3. Contraindication to microUS or MRI; 4. Testosterone replacement therapy within last 12 months; or 5. Androgen deprivation therapy within last 12 months.

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As listed by the trial registrant

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

Prostate cancer screening

How to take part

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

  1. The places running it

    8 sites in 5 countries. 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

  • CH de Martigues

    RECRUITING

    Martigues, France

  • CIUSSS du Nord-de-l'Île-de-Montréal

    NOT_YET_RECRUITING

    Montréal, Quebec, H4J 1C5, Canada

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • UT Southwestern Medical Center

    NOT_YET_RECRUITING

    Dallas, Texas, 75390, United States

  • University of Alberta

    ACTIVE_NOT_RECRUITING

    Edmonton, Alberta, T6G 1Z1, Canada

  • University of British Columbia

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • University of California, Los Angeles (UCLA)

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • Urologia Clinica Bilbao

    RECRUITING

    Bilbao, Spain

  • Vestfold Hospital Trust

    RECRUITING

    Tønsberg, Norway

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