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Sound waves vs. prostate cancer: a gentler approach?

NCT ID NCT03568188

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a treatment called focused ultrasound (HIFU) that aims to destroy only the cancerous part of the prostate, avoiding common side effects like incontinence and impotence from standard treatments. It involved 174 men aged 50-80 with intermediate-risk prostate cancer. The main goal was to see if the cancer was controlled one year after treatment, based on biopsy results.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

174 people

The number who actually took part.

Started

Sep 2018

Finished

Feb 2026

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 80 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: * Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study. * Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have a G8 score \> 14. * Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics: * A multiparametric MRI showing a single invasive tumor focus at most two contiguous sextants confirmed by biopsies (index tumor). Patients with multiple suspected MRI foci may be included if only one of these foci is confirmed by targeted biopsies. * Gleason score= 7 (3+4). * Tumor accessible to a Focal-HIFU treatment. For apical tumor, it must be localized more than 9 mm from the external sphincter * PSA ≤ 15ng / ml. * Patient affiliated with health insurance or beneficiary of an equivalent plan. Exclusion Criteria: * Contraindications to treatment with HIFU-F: * Tumor not accessible. * Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment. * History of pelvic irradiation * Presence of an implant (stent, catheter) located less than 1 cm from the treatment area. * Fistula of the urinary tract or rectum. * Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe. * Anatomical abnormality of the rectum or rectal mucosa. * Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent. * History of intestinal inflammatory pathology. * Uro-genital infection in progress (the infection to be treated before HIFU treatment). * Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible. * Allergy to latex. * Thickness of the rectal wall\> 10mm. * TURP indication. Bladder neck incision is allowed. * Patient with a medical contraindication to Sonovue® injection. * Patient with a medical contraindication on MRI. * Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery). * History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer). * History of pelvic radiotherapy. * History of sclerosis of the bladder neck or urethral stenosis. * Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy). * Patients with unstable neurological pathology. * Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study. * Legal person protected by law. * Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.

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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.

Contacts and locations

Locations

  • CHU de Toulouse - Hôpital de Rangueil

    Toulouse, 31400, France

  • Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

    Pierre-Bénite, 69495, France

  • Clinique Saint-Vincent

    Besançon, 25044, France

  • Clinique Urologique Nantes Atlantis

    Saint-Herblain, 44800, France

  • Département d'Urologie, Institut Montsouris

    Paris, 75014, France

  • Groupe Hospitalier Pellegrin - CHU

    Bordeaux, 33076, France

  • Hôpital L. Pasteur, Hôpitaux Civils de Colmar

    Colmar, 68024, France

  • Polyclinique du parc Rambot

    Aix-en-Provence, 13100, France

  • Service d'Urologie CHRU de Lille, Hôpital HURIEZ

    Lille, 59000, France

  • Service d'Urologie Générale de Santé - Hôpital Privé La Louvière

    Lille, 59000, France

  • Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,

    Lyon, 69437, France

  • Service d'Urologie, Clinique Tivoli Ducos

    Bordeaux, 33000, France

  • Service d'Urologie, Hôpital Foch

    Suresnes, 92150, France

  • Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord

    Marseille, 13915, France

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