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

Study Overview
=================
Brief Summary
-----------------
to compare the efficacy of HIFU treatment with standard treatment in two situations: as first-line cancer treatment, HIFU is compared to radical prostatectomy. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.

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)

Conditions
-----------------
Prostate Cancer, Ultrasound Therapy

Intervention / Treatment
-----------------
* Procedure: Radical Prostatectomy
* Procedure: High Intensity Focused Ultrasound (HIFU) Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIFU<br>Patients Treated with high intensity focused ultrasound (HIFU) | Procedure: High Intensity Focused Ultrasound (HIFU) Treatment<br>* 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.<br>|
| Active Comparator: Prostatectomy<br>Patients Treated by Radical Prostatectomy | Procedure: Radical Prostatectomy<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIFU