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New ultrasound could catch prostate cancers MRI misses

NCT ID NCT07386171

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a high-resolution ultrasound technique, called micro-ultrasound, can find aggressive prostate cancers that standard MRI might miss. Researchers will enroll 90 men with low-risk prostate cancer who have negative or stable MRI results. Participants will get a micro-ultrasound exam, and if suspicious areas are seen, targeted biopsies will be taken. The goal is to see if this imaging method improves detection of clinically significant prostate cancer, potentially offering a more accessible and accurate diagnostic tool.

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 imaging
What this could lead to
If successful, micro-ultrasound could become a reliable, real-time tool to catch aggressive prostate cancers that MRI misses, helping men avoid unnecessary biopsies or delayed treatment.
What could go wrong
This is a small, early-stage study (90 participants) testing a new imaging technique. It may not prove accurate enough to replace MRI, and results may not apply to all men with prostate cancer.

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 90 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

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

45 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: * Male participants aged 45 to 75 years * Localized prostate cancer on active surveillance or newly diagnosed and eligible for active surveillance * Negative multiparametric MRI (PI-RADS ≤2) or stable mpMRI findings on surveillance * Prior prostate biopsy showing Grade Group 1, or Grade Group 2 (Gleason 3+4) with ≤10% pattern 4 * PSA ≤15 ng/mL * PSA density \<0.15 ng/mL/cc * Clinical stage ≤T2a * Life expectancy \>10 years * Ability to provide written informed consent and comply with study procedures Exclusion Criteria: * Prior definitive treatment for prostate cancer (e.g., radical prostatectomy, radiotherapy) * Prior prostate surgery that may affect biopsy or imaging interpretation * Contraindication to prostate biopsy * Active urinary tract infection or prostatitis * Inability to tolerate the biopsy procedure or follow study procedures

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

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