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New study tests if focused ultrasound can replace prostate removal surgery

NCT ID NCT05710861

Disease control Sponsor: University Hospital, Bordeaux 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two treatments for men with intermediate-risk prostate cancer: focal HIFU (a targeted ultrasound that destroys only the tumor) and radical prostatectomy (complete removal of the prostate). The goal is to see which approach offers better value for money and quality of life. About 346 men aged 45-75 will take part, and researchers will track costs and health outcomes for two years.

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 346 people

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

Started

Mar 2023

Expected to finish

Jun 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 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: * 45-75 yo male harboring a non-treated localized prostatic adenocarcinoma of maximum Gleason score 3+4, ISUP 2 unilateral on at most maximum 2 contiguous sextants (favorable intermediate risk),with or without ipsilateral or contralateral focus of score 3+3 (ISUP1). * Tumor visible on MRI and proven by systematic and/or targeted biopsies according to the center's practices, regardless of the route used (transrectal or transpirenal) * Or patients under active surveillance whose follow-up prostate biopsies reveal unilateral ISUP2 on at most 2 contiguous sextants (favorable intermediate risk), with or without ipsilateral or contralateral Gleason 3+3 focus (ISUP1) * Patients with several suspicious foci on MRI may be be included if only one of these foci is confirmed by targeted biopsies with an ISUP2 score. If more than one suspected site on MRI is confirmed by targeted biopsies, these should be unilateral ISUP2 on a maximum of 2 contiguous sextants (favourable intermediate risk), with or without an ipsilateral or contralateral site with a Gleason score of 3+3 (ISUP1). * stage T1c-T2, * with PSA \<20 ng/ml, * with prostate volume less than 150 ml, * patient clearly informed of the study and having agreed, with sufficient time for reflection to participate by signing the study's informed consent form, * patient affiliated to or benefiting from a social security scheme Exclusion Criteria: * Metastatic prostate cancer. * Gleason score \> 3+4 (ISUP\>2). * Adenoma prostate carcinoma Cribriform or intraductal. * Previous treatment anterior for the same cancer, whatever modality. * Contra-indication to pelvic MRI with gadolinium injection. * Contra-indication to surgery or general anesthesia. * Patient who refuse the one-year follow-up control biopsy after F-HIFU. * Presence of implant (stent, catheter) less than 1 cm from the treatment area. * Urinary or rectal fistula. * Anal or rectal stenosis or any other abnormality that may interfere with the Focal One® endorectal probe introduction. * Anatomic abnormality of the rectum or rectal mucosa. * Presence of a urinary artificial sphincter, a penile prosthesis or intraprostatic implant, i.e. urethral prosthesis. * Bladder neck and/or urethral stenosis or sclerosis. * Inflammatory bowel disease (colon or rectum). * Ongoing UTI (should be treated before the F-HIFU or the RP). * Previous anal or rectal surgery that may interfere with the anal probe introduction. * Latex allergy. * Rectal wall thickness \> 10 mm. * Tumor not accessible to a F-HIFU treatment (tumors located in the fibro-muscular anterior zone). * Previous not controlled cancer and/or treated since less than 5 years (except basocellular skin cancer). * Patient not able to understand the trial objectives or refusing to adhere to the trial instructions. * Patients under law-protection. * Patient in an ongoing research trial. * Patient with a severe health or psychologic problem that could impair the protocol pathway.

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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

    19 sites in 2 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

  • APHM Nord Marseille

    RECRUITING

    Marseille, 13015, France

  • CH Saintonge

    RECRUITING

    Saint-Jean-d'Angély, France

  • CHU Grenoble Alpes

    RECRUITING

    Grenoble, France

  • CHU Pointe à Pitre

    NOT_YET_RECRUITING

    Pointe-à-Pitre, Guadeloupe

  • CHU Toulouse rangueil

    RECRUITING

    Toulouse, 31400, France

  • CHU de Bordeaux

    RECRUITING

    Bordeaux, 33076, France

  • CHU de Rennes

    RECRUITING

    Rennes, France

  • Clinique La Croix du Sud

    RECRUITING

    Quint-Fonsegrives, 31130, France

  • Clinique Oceane

    RECRUITING

    Vannes, 56000, France

  • Clinique Saint Michel

    RECRUITING

    Toulon, 83100, France

  • Clinique Saint Vincent

    RECRUITING

    Besançon, 25000, France

  • Clinique Tivoli

    RECRUITING

    Bordeaux, 33000, France

  • Hopital Claude HURIEZ

    RECRUITING

    Lille, 59000, France

  • Hopital Cochin

    RECRUITING

    Paris, 75014, France

  • Hopital Edouard Herriot Pavillon V

    RECRUITING

    Lyon, 69437, France

  • Hopital Lyon Sud HCL Bat 3C Centre

    RECRUITING

    Pierre-Bénite, 69310, France

  • Hopital Privé La Louviere

    RECRUITING

    Lille, 59800, France

  • Hopital Privé francheville

    RECRUITING

    Périgueux, 204004, France

  • Hopital prive drome ardeche

    RECRUITING

    Guilherand-Granges, 07500, France

  • Hopitaux civil de Colmar

    WITHDRAWN

    Colmar, 68024, France

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