Back to resultsEvaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY (HIFI)
Primary Purpose
Prostate Cancer, Ultrasound Therapy
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Radical Prostatectomy
High Intensity Focused Ultrasound (HIFU) Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring HIFU
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
Sites / Locations
- Centre Hospitalier d'Aix en Provence
- Polyckinique du Beaujolais
- Clinique St Etienne
- CHRU de Besançon
- Clinique St Vincent
- Clinique Tivoli-Ducos
- Clinique St Augustin
- CHU de Bordeaux
- Nouvelle clinique Bel Air
- Pôle Santé Léonard de Vinci
- CHR de Chambéry
- PôleSanté République
- Hôpitaux civils de Colmar
- Polyclinique du parc Drevon
- CHU de Dijon
- CHU de Grenoble
- Hôpital Privé Drome Ardèche
- Cliique du Pré
- Clinique Bon Secours
- CHRU de Lille
- Clinique La Louvière
- CHU de Limoges
- Hospices Civils de lyon
- Hôpital St Joseph
- AP-AM
- Clinique Beau Soleil
- Clinique Diaconat-Roosevelt
- CHU de Nice
- CHU de Nîmes
- Fondation St Jean de Dieu - Clinique Oudinot
- Clinique Turin
- Hôpital St Joseph
- Hôpital TENON
- Institut Mutualiste Montsouris
- Hôpital Europeen Georges Pompidou
- CH de pontoise
- Clinique Courlancy
- CHU de rennes
- Clinique Nantes Atlantis
- CH de Saintonge
- Clinique Rhéna
- Hôpital Foch
- Clinique St Michel
- CHU de Toulouse
- Clinique Pasteur
- Clinique St Jean du Languedoc
- Clinique Océanne
- Cliniqe du Val d'Ouest
- CHU de guadeloupe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HIFU
Prostatectomy
Arm Description
Patients Treated with high intensity focused ultrasound (HIFU)
Patients Treated by Radical Prostatectomy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
immediate or late complications
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
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
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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
The rate of local recurrence
The rate of local recurrence is measured by control biopsy (number of positive biopsies)
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04307056
First Posted
February 7, 2020
Last Updated
January 11, 2023
Sponsor
Association Francaise d'Urologie
1. Study Identification
Unique Protocol Identification Number
NCT04307056
Brief Title
Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 23, 2015 (Actual)
Primary Completion Date
August 24, 2022 (Actual)
Study Completion Date
August 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Francaise d'Urologie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Ultrasound Therapy
Keywords
HIFU
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3862 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIFU
Arm Type
Experimental
Arm Description
Patients Treated with high intensity focused ultrasound (HIFU)
Arm Title
Prostatectomy
Arm Type
Active Comparator
Arm Description
Patients Treated by Radical Prostatectomy
Intervention Type
Procedure
Intervention Name(s)
Radical Prostatectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
High Intensity Focused Ultrasound (HIFU) Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence-free survival
Description
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
Secondary Outcome Measure Information:
Title
Immediate or late complications
Description
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time Frame
6 weeks after treatment
Title
Immediate or late complications
Description
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time Frame
Day 0, Inclusion
Title
immediate or late complications
Description
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time Frame
3 months after treatment
Title
immediate or late complications
Description
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time Frame
6 months after treatment
Title
immediate or late complications
Description
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time Frame
12 months after treatment
Title
immediate or late complications
Description
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time Frame
18 months after treatment
Title
immediate or late complications
Description
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time Frame
24 months after treatment
Title
immediate or late complications
Description
clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Time Frame
30 months after treatment
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
urinary function
Description
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
Title
sexual fonction
Description
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
Title
sexual fonction
Description
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
Title
sexual fonction
Description
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
Title
sexual fonction
Description
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
Title
sexual fonction
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of quality of life
Description
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
Title
The rate of patients in biochemical failure
Description
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
Title
The rate of patients in biochemical failure
Description
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
Title
The rate of patients in biochemical failure
Description
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
Title
The rate of patients in biochemical failure
Description
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
Title
The rate of patients in biochemical failure
Description
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
Title
The rate of patients in biochemical failure
Description
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
Title
The rate of patients in biochemical failure
Description
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
Title
The rate of local recurrence
Description
The rate of local recurrence is measured by control biopsy (number of positive biopsies)
Time Frame
3 months after treatment
Title
Survival without metastases
Description
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
Title
Survival without metastases
Description
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
Title
Survival without metastases
Description
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
Title
Survival without metastases
Description
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
Title
Survival without metastases
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre Hospitalier d'Aix en Provence
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Facility Name
Polyckinique du Beaujolais
City
Arnas
ZIP/Postal Code
69400
Country
France
Facility Name
Clinique St Etienne
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
CHRU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
Clinique St Vincent
City
Besançon
ZIP/Postal Code
25044
Country
France
Facility Name
Clinique Tivoli-Ducos
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Clinique St Augustin
City
Bordeaux
ZIP/Postal Code
33074
Country
France
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Nouvelle clinique Bel Air
City
Bordeaux
ZIP/Postal Code
33200
Country
France
Facility Name
Pôle Santé Léonard de Vinci
City
Chambray-lès-Tours
ZIP/Postal Code
37170
Country
France
Facility Name
CHR de Chambéry
City
Chambéry
ZIP/Postal Code
73011
Country
France
Facility Name
PôleSanté République
City
Clermont-Ferrand
ZIP/Postal Code
63050
Country
France
Facility Name
Hôpitaux civils de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Polyclinique du parc Drevon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hôpital Privé Drome Ardèche
City
Guilherand-Granges
ZIP/Postal Code
07500
Country
France
Facility Name
Cliique du Pré
City
Le Mans
ZIP/Postal Code
72018
Country
France
Facility Name
Clinique Bon Secours
City
Le Puy-en-Velay
ZIP/Postal Code
43000
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Clinique La Louvière
City
Lille
ZIP/Postal Code
59042
Country
France
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hospices Civils de lyon
City
Lyon
ZIP/Postal Code
69002
Country
France
Facility Name
Hôpital St Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
AP-AM
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Clinique Beau Soleil
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Clinique Diaconat-Roosevelt
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Fondation St Jean de Dieu - Clinique Oudinot
City
Paris
ZIP/Postal Code
75007
Country
France
Facility Name
Clinique Turin
City
Paris
ZIP/Postal Code
75008
Country
France
Facility Name
Hôpital St Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital TENON
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hôpital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
CH de pontoise
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
Clinique Courlancy
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
CHU de rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Clinique Nantes Atlantis
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
CH de Saintonge
City
Saintes
ZIP/Postal Code
17108
Country
France
Facility Name
Clinique Rhéna
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Facility Name
Clinique St Michel
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Clinique St Jean du Languedoc
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Clinique Océanne
City
Vannes
ZIP/Postal Code
56000
Country
France
Facility Name
Cliniqe du Val d'Ouest
City
Écully
ZIP/Postal Code
69130
Country
France
Facility Name
CHU de guadeloupe
City
pointe-à-Pitre
ZIP/Postal Code
97159
Country
Guadeloupe
12. IPD Sharing Statement
Learn more about this trial
Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY
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