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Two MRI scans better than one for prostate cancer detection?

NCT ID NCT07355504

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new way to detect prostate cancer early by looking at changes in MRI scans over time instead of relying on a single scan. About 380 men with suspicious MRI findings will be followed to see if this approach reduces unnecessary biopsies and over-treatment. The goal is to catch only the cancers that truly need treatment.

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 380 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2033

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

18 years and older

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: * Men aged over 18 years * Men with an estimated life expectancy of more than 10 years * Biopsy-naïve men * PSA level ≤ 20 ng/ml * Presence, on the first multiparametric prostate MRI, of a PIRADS 3-5 lesion confirmed by local rereading if the MRI was performed outside the center * MRI of sufficient quality (PI-QUAL score 2-3) * PIRADS 3 lesion with a PSA density \<0.15 ng/ml/ml * No signs of extracapsular extension or seminal vesicle invasion (MRI stage T2 confirmed by local rereading if MRI performed outside the center) * No suspicious lymph node (confirmed by local rereading if MRI performed outside the center) * Patient is insured (affiliated with the national health insurance system or benefiting from such coverage) * Signed informed consent form Exclusion Criteria: * Men already under surveillance for a known MRI lesion (except if the previous MRI was performed less than 6 months ago) * Known mutation in DNA repair genes or suggestive family history * PIRADS 3 lesion with PSA density \< 0.15 ng/ml/ml * PIRADS 5 lesion with suspected extracapsular extension or seminal vesicle invasion * Suspicion of lymph node involvement * Multiparametric prostate MRI showing a PIRADS 1-2 lesion * Use of treatments that may modify the appearance of MRI lesions: 5-alpha reductase inhibitors, hormone therapy * Patient with severe renal insufficiency (GFR \< 30 ml/min/1.73 m²) * Contraindication to gadolinium injection * Contraindication to prostate biopsy * Vulnerable persons (covered by Articles L1111-6 to L1111-8 of the French Public Health Code)

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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

  • university Hospital Grenoble

    Grenoble, Grenoble, 38043, France

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