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)

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Ultrasound Therapy
• Intervention / Treatment: Procedure: High Intensity Focused Ultrasound (HIFU) Treatment; Procedure: Radical Prostatectomy

• Study Type: Interventional
• Enrollment (Actual): 3862
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France, 13616
    • Centre Hospitalier d'Aix en Provence
  • Arnas, France, 69400
    • Polyckinique du Beaujolais
  • Bayonne, France, 64100
    • Clinique St Etienne
  • Besançon, France, 25000
    • CHRU De Besancon
  • Besançon, France, 25044
    • Clinique St Vincent
  • Bordeaux, France, 33200
    • Nouvelle Clinique Bel Air
  • Bordeaux, France, 33076
    • CHU de Bordeaux
  • Bordeaux, France, 33000
    • Clinique Tivoli-Ducos
  • Bordeaux, France, 33074
    • Clinique St Augustin
  • Chambray-lès-Tours, France, 37170
    • Pole Sante Leonard de Vinci
  • Chambéry, France, 73011
    • CHR de Chambéry
  • Clermont-Ferrand, France, 63050
    • PôleSanté République
  • Colmar, France, 68024
    • Hopitaux Civils de Colmar
  • Dijon, France, 21079
    • CHU de Dijon
  • Dijon, France, 21000
    • Polyclinique du Parc Drevon
  • Grenoble, France, 38043
    • CHU de GRENOBLE
  • Guilherand-Granges, France, 07500
    • Hôpital Privé Drôme Ardèche
  • Le Mans, France, 72018
    • Cliique du Pré
  • Le Puy-en-Velay, France, 43000
    • Clinique Bon Secours
  • Lille, France, 59037
    • CHRU de Lille
  • Lille, France, 59042
    • Clinique La Louvière
  • Limoges, France, 87042
    • CHU de Limoges
  • Lyon, France, 69002
    • Hospices Civils de Lyon
  • Marseille, France, 13008
    • Hôpital St Joseph
  • Marseille, France, 13015
    • AP-AM
  • Montpellier, France, 34070
    • Clinique Beau Soleil
  • Mulhouse, France, 68100
    • Clinique Diaconat-Roosevelt
  • Nice, France, 06200
    • CHU de Nice
  • Nîmes, France, 30029
    • Chu de Nimes
  • Paris, France, 75020
    • Hôpital Tenon
  • Paris, France, 75908
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75008
    • Clinique Turin
  • Paris, France, 75007
    • Fondation St Jean de Dieu - Clinique Oudinot
  • Paris, France, 75014
    • Hôpital St Joseph
  • Paris, France, 75674
    • Institut Mutualiste Montsouris
  • Pontoise, France, 95300
    • CH de Pontoise
  • Reims, France, 51100
    • Clinique Courlancy
  • Rennes, France, 35033
    • CHU de Rennes
  • Saint-Herblain, France, 44800
    • Clinique Nantes Atlantis
  • Saintes, France, 17108
    • CH de Saintonge
  • Strasbourg, France, 67000
    • Clinique Rhéna
  • Suresnes, France, 92150
    • Hôpital Foch
  • Toulon, France, 83000
    • Clinique St Michel
  • Toulouse, France, 31059
    • CHU de Toulouse
  • Toulouse, France, 31076
    • Clinique PASTEUR
  • Toulouse, France, 31400
    • Clinique St Jean du Languedoc
  • Vannes, France, 56000
    • Clinique Océanne
  • Écully, France, 69130
    • Cliniqe du Val d'Ouest
• Guadeloupe
  • pointe-à-Pitre, Guadeloupe, 97159
    • CHU de Guadeloupe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

General inclusion criteria

• 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

Inclusion criteria for the HIFU Arm

• 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

Inclusion Criteria for Total Prostatectomy Arm

• Patients with a life expectancy greater than 10 years and a state of health allowing general anaesthesia.

NON-INCLUSION CRITERIA

• Patient participating in other biomedical research within 3 months prior to their inclusion in this protocol
• Included patient simultaneously participating in another research study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIFU; Patients Treated with high intensity focused ultrasound (HIFU)	Procedure: 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.
Active Comparator: Prostatectomy; Patients Treated by Radical Prostatectomy	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	6 weeks after treatment
Immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	Day 0, Inclusion
immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	3 months after treatment
immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	6 months after treatment
immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	12 months after treatment
immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	18 months after treatment
immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	24 months after treatment
immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	30 months after treatment
urinary function	measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort	Day 0, Inclusion
urinary function	measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort	6 months after treatment
urinary function	measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort	12 months after treatment
urinary function	measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort	24 months after treatment
urinary function	measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort	30 months after treatment
urinary function	Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more) Translated with www.DeepL.com/Translator (free version)	Day 0, Inclusion
urinary function	Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more) Translated with www.DeepL.com/Translator (free version)	6 months after treatment
urinary function	Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more) Translated with www.DeepL.com/Translator (free version)	12 months after treatment
urinary function	Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more) Translated with www.DeepL.com/Translator (free version)	18 months after treatment
urinary function	Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more) Translated with www.DeepL.com/Translator (free version)	24 months after treatment
urinary function	Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more) Translated with www.DeepL.com/Translator (free version)	30 months after treatment
urinary function	Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores: stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)	Day 0, Inclusion
urinary function	Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores: stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)	6 months after treatment
urinary function	Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores: stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)	12 months after treatment
urinary function	Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores: stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)	18 months after treatment
urinary function	Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores: stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)	24 months after treatment
urinary function	Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores: stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)	30 months after treatment
sexual fonction	Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function	Day 0, Inclusion
sexual fonction	Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function	6 months after treatment
sexual fonction	Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function	12 months after treatment
sexual fonction	Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function	24 months after treatment
sexual fonction	Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function	30 months after treatment
Evaluation of quality of life	Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent)	Day 0, Inclusion
Evaluation of quality of life	Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent)	6 months after treatment
Evaluation of quality of life	Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent)	12 months after treatment
Evaluation of quality of life	Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent)	18 months after treatment
Evaluation of quality of life	Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent)	24 months after treatment
Evaluation of quality of life	Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent)	30 months after treatment
Evaluation of quality of life	Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many)	Day 0, Inclusion
Evaluation of quality of life	Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many)	6 months after treatment
Evaluation of quality of life	Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many)	12 months after treatment
Evaluation of quality of life	Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many)	18 months after treatment
Evaluation of quality of life	Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many)	24 months after treatment
Evaluation of quality of life	Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many)	30 months after treatment
Evaluation of quality of life	Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility) 1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy) 1 (no problem) to 3 (unable) Questions 7 to 9 (current activities) 1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort) 1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression) 1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)	Day 0, Inclusion
Evaluation of quality of life	Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility) 1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy) 1 (no problem) to 3 (unable) Questions 7 to 9 (current activities) 1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort) 1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression) 1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)	6 months after treatment
Evaluation of quality of life	Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility) 1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy) 1 (no problem) to 3 (unable) Questions 7 to 9 (current activities) 1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort) 1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression) 1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)	12 months after treatment
Evaluation of quality of life	Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility) 1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy) 1 (no problem) to 3 (unable) Questions 7 to 9 (current activities) 1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort) 1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression) 1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)	18 months after treatment
Evaluation of quality of life	Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility) 1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy) 1 (no problem) to 3 (unable) Questions 7 to 9 (current activities) 1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort) 1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression) 1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)	24 months after treatment
Evaluation of quality of life	Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility) 1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy) 1 (no problem) to 3 (unable) Questions 7 to 9 (current activities) 1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort) 1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression) 1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)	30 months after treatment
The rate of patients in biochemical failure	The rate of patients in biochemical failure is measured by PSA dosage: PSA > 0.2 ng for patients treated by radical surgery; PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU	6 weeks after treatment
The rate of patients in biochemical failure	The rate of patients in biochemical failure is measured by PSA dosage: PSA > 0.2 ng for patients treated by radical surgery; PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU	3 months after treatment
The rate of patients in biochemical failure	The rate of patients in biochemical failure is measured by PSA dosage: PSA > 0.2 ng for patients treated by radical surgery; PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU	6 months after treatment
The rate of patients in biochemical failure	The rate of patients in biochemical failure is measured by PSA dosage: PSA > 0.2 ng for patients treated by radical surgery; PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU	12 months after treatment
The rate of patients in biochemical failure	The rate of patients in biochemical failure is measured by PSA dosage: PSA > 0.2 ng for patients treated by radical surgery; PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU	18 months after treatment
The rate of patients in biochemical failure	The rate of patients in biochemical failure is measured by PSA dosage: PSA > 0.2 ng for patients treated by radical surgery; PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU	24 months after treatment
The rate of patients in biochemical failure	The rate of patients in biochemical failure is measured by PSA dosage: PSA > 0.2 ng for patients treated by radical surgery; PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU	30 months after treatment
The rate of local recurrence	The rate of local recurrence is measured by control biopsy (number of positive biopsies)	3 months after treatment
Survival without metastases	demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.	6 months after treatment
Survival without metastases	demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.	12 months after treatment
Survival without metastases	demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.	18 months after treatment
Survival without metastases	demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.	24 months after treatment
Survival without metastases	demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.	30 months after treatment

Collaborators and Investigators

• Sponsor: Association Francaise d'Urologie

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2015
• Primary Completion (Actual): August 24, 2022
• Study Completion (Actual): August 24, 2022

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: HIFU
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Recurrence
• Other Study ID Numbers: HIFU/AFU/12.03; 2013-A01042-43 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No