Sound waves vs. prostate cancer: a gentler approach?
NCT ID NCT03568188
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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174 people
The number who actually took part.
- Started
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Sep 2018
- Finished
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Feb 2026
- Lead sponsor
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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
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50 to 80 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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CHU de Toulouse - Hôpital de Rangueil
Toulouse, 31400, France
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Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
Pierre-Bénite, 69495, France
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Clinique Saint-Vincent
Besançon, 25044, France
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Clinique Urologique Nantes Atlantis
Saint-Herblain, 44800, France
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Département d'Urologie, Institut Montsouris
Paris, 75014, France
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Groupe Hospitalier Pellegrin - CHU
Bordeaux, 33076, France
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Hôpital L. Pasteur, Hôpitaux Civils de Colmar
Colmar, 68024, France
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Polyclinique du parc Rambot
Aix-en-Provence, 13100, France
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Service d'Urologie CHRU de Lille, Hôpital HURIEZ
Lille, 59000, France
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Service d'Urologie Générale de Santé - Hôpital Privé La Louvière
Lille, 59000, France
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Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,
Lyon, 69437, France
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Service d'Urologie, Clinique Tivoli Ducos
Bordeaux, 33000, France
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Service d'Urologie, Hôpital Foch
Suresnes, 92150, France
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Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord
Marseille, 13915, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?