Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY
HIFI
EVALUATION OF HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) IN CURATIVE TREATMENT OF LOCALIZED PROSTATE CANCER AT LOW OR INTERMEDIATE RISK AND IN TREATMENT OF RECURRENCE AFTER RADIOTHERAPY (FORFAIT INNOVATION ART L165-1-1 Social Security Code)
2 other identifiers
interventional
3,862
2 countries
49
Brief Summary
to compare the efficacy of HIFU treatment with standard treatment in two situations:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Mar 2015
Longer than P75 for not_applicable prostate-cancer
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2015
CompletedFirst Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2022
CompletedJanuary 12, 2023
November 1, 2022
7.4 years
February 7, 2020
January 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence-free survival
The main objective for patients is to compare recurrence-free survival (i.e., the rate of salvage therapy by external beam radiotherapy and/or hormone therapy) in patients treated by HIFU and those treated by radical prostatectomy. The implementation of salvage therapy will be decided according to several non-exclusive criteria (positivity of margins (for patients with radical prostatectomy), PSA at 3 months, biologic recurrence (increase in PSA \> 0.2 ng/ml after radical surgery, \> Nadir +2 after HIFU), control biopsies positive, the appearance of metastases
30 months
Secondary Outcomes (61)
Immediate or late complications
6 weeks after treatment
Immediate or late complications
Day 0, Inclusion
immediate or late complications
3 months after treatment
immediate or late complications
6 months after treatment
immediate or late complications
12 months after treatment
- +56 more secondary outcomes
Study Arms (2)
HIFU
EXPERIMENTALPatients Treated with high intensity focused ultrasound (HIFU)
Prostatectomy
ACTIVE COMPARATORPatients Treated by Radical Prostatectomy
Interventions
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.
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
You may qualify if:
- Patients with localized adenocarcinoma of the prostate classified as T1-2, N0, Nx M0
- 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.
- Included patient simultaneously participating in another research study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Centre Hospitalier d'Aix en Provence
Aix-en-Provence, 13616, France
Polyckinique du Beaujolais
Arnas, 69400, France
Clinique St Etienne
Bayonne, 64100, France
CHRU de Besançon
Besançon, 25000, France
Clinique St Vincent
Besançon, 25044, France
Clinique Tivoli-Ducos
Bordeaux, 33000, France
Clinique St Augustin
Bordeaux, 33074, France
CHU de Bordeaux
Bordeaux, 33076, France
Nouvelle clinique Bel Air
Bordeaux, 33200, France
CHR de Chambéry
Chambéry, 73011, France
Pôle Santé Léonard de Vinci
Chambray-lès-Tours, 37170, France
PôleSanté République
Clermont-Ferrand, 63050, France
Hôpitaux civils de Colmar
Colmar, 68024, France
Polyclinique du parc Drevon
Dijon, 21000, France
CHU de Dijon
Dijon, 21079, France
Cliniqe du Val d'Ouest
Écully, 69130, France
CHU de Grenoble
Grenoble, 38043, France
Hôpital Privé Drome Ardèche
Guilherand-Granges, 07500, France
Cliique du Pré
Le Mans, 72018, France
Clinique Bon Secours
Le Puy-en-Velay, 43000, France
CHRU de Lille
Lille, 59037, France
Clinique La Louvière
Lille, 59042, France
CHU de Limoges
Limoges, 87042, France
Hospices Civils de lyon
Lyon, 69002, France
Hôpital St Joseph
Marseille, 13008, France
AP-AM
Marseille, 13015, France
Clinique Beau Soleil
Montpellier, 34070, France
Clinique Diaconat-Roosevelt
Mulhouse, 68100, France
CHU de Nice
Nice, 06200, France
CHU de Nîmes
Nîmes, 30029, France
Fondation St Jean de Dieu - Clinique Oudinot
Paris, 75007, France
Clinique Turin
Paris, 75008, France
Hôpital St Joseph
Paris, 75014, France
Hôpital TENON
Paris, 75020, France
Institut Mutualiste Montsouris
Paris, 75674, France
Hôpital Europeen Georges Pompidou
Paris, 75908, France
CH de pontoise
Pontoise, 95300, France
Clinique Courlancy
Reims, 51100, France
CHU de rennes
Rennes, 35033, France
Clinique Nantes Atlantis
Saint-Herblain, 44800, France
CH de Saintonge
Saintes, 17108, France
Clinique Rhéna
Strasbourg, 67000, France
Hôpital Foch
Suresnes, 92150, France
Clinique St Michel
Toulon, 83000, France
CHU de Toulouse
Toulouse, 31059, France
Clinique Pasteur
Toulouse, 31076, France
Clinique St Jean du Languedoc
Toulouse, 31400, France
Clinique Océanne
Vannes, 56000, France
CHU de guadeloupe
Pointe-à-Pitre, 97159, Guadeloupe
Related Publications (1)
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.
PMID: 39632125DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2020
First Posted
March 13, 2020
Study Start
March 23, 2015
Primary Completion
August 24, 2022
Study Completion
August 24, 2022
Last Updated
January 12, 2023
Record last verified: 2022-11