Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY

Prostate Cancer Clinical Trial

— HIFI  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04307056
• Other study ID #: HIFU/AFU/12.03
• Secondary ID: 2013-A01042-43
• Status: Completed
• Phase: N/A
• Start date: March 23, 2015
• Est. completion date: August 24, 2022

Study information

• Verified date: November 2022
• Source: Association Francaise d'Urologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3862
• Est. completion date: August 24, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Recurrence
• Ultrasound Therapy

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	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	CHU de Bordeaux	Bordeaux
France	Clinique St Augustin	Bordeaux
France	Clinique Tivoli-Ducos	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	CHU de Dijon	Dijon
France	Polyclinique du parc Drevon	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	AP-AM	Marseille
France	Hôpital St Joseph	Marseille
France	Clinique Beau Soleil	Montpellier
France	Clinique Diaconat-Roosevelt	Mulhouse
France	CHU de Nice	Nice
France	CHU de Nîmes	Nîmes
France	Clinique Turin	Paris
France	Fondation St Jean de Dieu - Clinique Oudinot	Paris
France	Hôpital Europeen Georges Pompidou	Paris
France	Hôpital St Joseph	Paris
France	Hôpital TENON	Paris
France	Institut Mutualiste Montsouris	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
Guadeloupe	CHU de guadeloupe	pointe-à-Pitre

Sponsors (1)

Lead Sponsor	Collaborator
Association Francaise d'Urologie

Countries where clinical trial is conducted

France,  Guadeloupe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	6 weeks after treatment
Secondary	Immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	Day 0, Inclusion
Secondary	immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	3 months after treatment
Secondary	immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	6 months after treatment
Secondary	immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	12 months after treatment
Secondary	immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	18 months after treatment
Secondary	immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	24 months after treatment
Secondary	immediate or late complications	clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)	30 months after treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The rate of local recurrence	The rate of local recurrence is measured by control biopsy (number of positive biopsies)	3 months after treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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