Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY
NCT ID: NCT04307056
Last Updated: 2023-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3862 participants
INTERVENTIONAL
2015-03-23
2022-08-24
Brief Summary
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1. as first-line cancer treatment, HIFU is compared to radical prostatectomy.
2. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HIFU
Patients Treated with high intensity focused ultrasound (HIFU)
High Intensity Focused Ultrasound (HIFU) Treatment
The treatment with High Intensity Focused Ultrasound (HIFU) evaluated in this study will be delivered by 2 types of medical devices currently available on the market, Ablatherm® and Focal One®. They are both computer-controlled and provided with an endo-rectal probe with integrated ultrasound, enabling planning and the monitoring of treatment of localized prostate cancer in realtime.
Prostatectomy
Patients Treated by Radical Prostatectomy
Radical Prostatectomy
The surgical approach can be open or laparoscopic. The procedure begins with lymph node dissection for the intermediate risk groups (PSA \> 10 ng/mL and/or presence of grade 4 Gleason score). Total prostatectomy includes removal of the seminal vesicles. It can preserve 1 or 2 neurovascular bundles, depending on the cancer stage and/or the choice expressed by the patient. The vesicourethral suture is either a running or interrupted suture, and there is drainage by a bladder catheter for at least 5 days.
Interventions
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Radical Prostatectomy
The surgical approach can be open or laparoscopic. The procedure begins with lymph node dissection for the intermediate risk groups (PSA \> 10 ng/mL and/or presence of grade 4 Gleason score). Total prostatectomy includes removal of the seminal vesicles. It can preserve 1 or 2 neurovascular bundles, depending on the cancer stage and/or the choice expressed by the patient. The vesicourethral suture is either a running or interrupted suture, and there is drainage by a bladder catheter for at least 5 days.
High Intensity Focused Ultrasound (HIFU) Treatment
The treatment with High Intensity Focused Ultrasound (HIFU) evaluated in this study will be delivered by 2 types of medical devices currently available on the market, Ablatherm® and Focal One®. They are both computer-controlled and provided with an endo-rectal probe with integrated ultrasound, enabling planning and the monitoring of treatment of localized prostate cancer in realtime.
Eligibility Criteria
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Inclusion Criteria
* classified as low or intermediate risk
* Patient with PSA \< 15 ng/ml, Gleason score ≤ 7 restricted to the form \[3 + 4\].
* Biopsy with at least 12 specimens and a maximum of four out of six invaded sextants
* Patient with a pelvic MRI if there is an intermediate risk and a bone scintigraphy if PSA \> 10 ng/ml
* Patient affiliated with health insurance or beneficiary of an equivalent plan
* Patients 70 years of age or older
* Patients with a life expectancy related to age and associated illness estimated to be greater than 5 years
• Patients with a life expectancy greater than 10 years and a state of health allowing general anaesthesia.
* Patient participating in other biomedical research within 3 months prior to their inclusion in this protocol
* Included patient simultaneously participating in another research study
70 Years
MALE
No
Sponsors
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Association Francaise d'Urologie
OTHER
Responsible Party
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Locations
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Centre Hospitalier d'Aix en Provence
Aix-en-Provence, , France
Polyckinique du Beaujolais
Arnas, , France
Clinique St Etienne
Bayonne, , France
CHRU de Besançon
Besançon, , France
Clinique St Vincent
Besançon, , France
Clinique Tivoli-Ducos
Bordeaux, , France
Clinique St Augustin
Bordeaux, , France
CHU de Bordeaux
Bordeaux, , France
Nouvelle clinique Bel Air
Bordeaux, , France
CHR de Chambéry
Chambéry, , France
Pôle Santé Léonard de Vinci
Chambray-lès-Tours, , France
PôleSanté République
Clermont-Ferrand, , France
Hôpitaux civils de Colmar
Colmar, , France
Polyclinique du parc Drevon
Dijon, , France
CHU de Dijon
Dijon, , France
Cliniqe du Val d'Ouest
Écully, , France
CHU de Grenoble
Grenoble, , France
Hôpital Privé Drome Ardèche
Guilherand-Granges, , France
Cliique du Pré
Le Mans, , France
Clinique Bon Secours
Le Puy-en-Velay, , France
CHRU de Lille
Lille, , France
Clinique La Louvière
Lille, , France
CHU de Limoges
Limoges, , France
Hospices Civils de lyon
Lyon, , France
Hôpital St Joseph
Marseille, , France
AP-AM
Marseille, , France
Clinique Beau Soleil
Montpellier, , France
Clinique Diaconat-Roosevelt
Mulhouse, , France
CHU de Nice
Nice, , France
CHU de Nîmes
Nîmes, , France
Fondation St Jean de Dieu - Clinique Oudinot
Paris, , France
Clinique Turin
Paris, , France
Hôpital St Joseph
Paris, , France
Hôpital TENON
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Hôpital Europeen Georges Pompidou
Paris, , France
CH de pontoise
Pontoise, , France
Clinique Courlancy
Reims, , France
CHU de rennes
Rennes, , France
Clinique Nantes Atlantis
Saint-Herblain, , France
CH de Saintonge
Saintes, , France
Clinique Rhéna
Strasbourg, , France
Hôpital Foch
Suresnes, , France
Clinique St Michel
Toulon, , France
CHU de Toulouse
Toulouse, , France
Clinique Pasteur
Toulouse, , France
Clinique St Jean du Languedoc
Toulouse, , France
Clinique Océanne
Vannes, , France
CHU de guadeloupe
Pointe-à-Pitre, , Guadeloupe
Countries
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References
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Ploussard G, Coloby P, Chevallier T, Occean BV, Houede N, Villers A, Rischmann P; HIFI group. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. 2025 May;87(5):526-533. doi: 10.1016/j.eururo.2024.11.006. Epub 2024 Dec 4.
Other Identifiers
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2013-A01042-43
Identifier Type: OTHER
Identifier Source: secondary_id
HIFU/AFU/12.03
Identifier Type: -
Identifier Source: org_study_id
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