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New biopsy method aims to cut unnecessary prostate cancer diagnoses

NCT ID NCT07296042

Diagnosis Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 2 times

Summary

This study compares two ways of taking prostate biopsies in men with suspected prostate cancer. The new method takes samples from the MRI-visible spot and nearby areas, while the standard method also samples random spots across the prostate. The goal is to see if the new approach catches dangerous cancers just as well but finds fewer harmless ones, reducing overdiagnosis and anxiety. About 456 men will take part across multiple centers.

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 456 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

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

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: * Adult men (≥ 18 years old) * Clinical suspicion of PCa (based on digital rectal examination, family history, PSA and PSA density values) and prescribed prostate biopsy * Detection by multi-parametric MRI of the prostate of a PI-RADS 4 or 5 index lesion, or a PI-RADS 3 index lesion with a PSA density ≥ 0.15 ng/ml/cc * Patient eligible for prostate biopsy under local or general anesthesia * PSA ≤ 20 ng/mL * Patient who agreed to participate in the study and signed the consent form Exclusion Criteria: * History of prostate cancer * History of negative prostate biopsy * MRI negative (PI-RADS 1 or 2) or equivocal (PI-RADS 3) with PSA density \< 0.15 ng/ml/cc * Patient unable to understand the terms of the study or unable to give informed consent (neurological or psychiatric disorders, non-French speaker, etc.) * Patient under full or partial legal guardianship.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

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

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

  • CHI Mont de Marsan - Site de Layné

    Mont-de-Marsan, 40024, France

  • CHU de Bordeaux

    Bordeaux, 33000, France

  • Clinique La Croix du Sud - RAMSAY Santé

    Quint-Fonsegrives, 31130, France

  • Hôpital Nord, Assistance Publique des Hôpitaux de Marseille

    Marseille, 13015, France

  • Hôpital privé des Peupliers - Ramsay Santé

    Paris, 75013, France

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