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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,862
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.
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
Time frame: 30 months
Immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time frame: 6 weeks after treatment
Immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time frame: Day 0, Inclusion
immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time frame: 3 months after treatment
immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time frame: 6 months after treatment
immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time frame: 12 months after treatment
immediate or late complications
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Centre Hospitalier d'Aix en Provence
Aix-en-Provence, France
Polyckinique du Beaujolais
Arnas, France
Clinique St Etienne
Bayonne, France
CHRU de Besançon
Besançon, France
Clinique St Vincent
Besançon, France
Clinique Tivoli-Ducos
Bordeaux, France
Clinique St Augustin
Bordeaux, France
CHU de Bordeaux
Bordeaux, France
Nouvelle clinique Bel Air
Bordeaux, France
CHR de Chambéry
Chambéry, France
...and 39 more locations
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time frame: 18 months after treatment
immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time frame: 24 months after treatment
immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 months after treatment
The rate of local recurrence
The rate of local recurrence is measured by control biopsy (number of positive biopsies)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 months after treatment