Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT04307056
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2020-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3862}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-free survival', 'timeFrame': '30 months', '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'}], 'secondaryOutcomes': [{'measure': 'Immediate or late complications', 'timeFrame': '6 weeks after treatment', 'description': 'clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)'}, {'measure': 'Immediate or late complications', 'timeFrame': 'Day 0, Inclusion', 'description': 'clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)'}, {'measure': 'immediate or late complications', 'timeFrame': '3 months after treatment', 'description': 'clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)'}, {'measure': 'immediate or late complications', 'timeFrame': '6 months after treatment', 'description': 'clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)'}, {'measure': 'immediate or late complications', 'timeFrame': '12 months after treatment', 'description': 'clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)'}, {'measure': 'immediate or late complications', 'timeFrame': '18 months after treatment', 'description': 'clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)'}, {'measure': 'immediate or late complications', 'timeFrame': '24 months after treatment', 'description': 'clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)'}, {'measure': 'immediate or late complications', 'timeFrame': '30 months after treatment', 'description': 'clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)'}, {'measure': 'urinary function', 'timeFrame': 'Day 0, Inclusion', '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'}, {'measure': 'urinary function', 'timeFrame': '6 months after treatment', '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'}, {'measure': 'urinary function', 'timeFrame': '12 months after treatment', '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'}, {'measure': 'urinary function', 'timeFrame': '24 months after treatment', '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'}, {'measure': 'urinary function', 'timeFrame': '30 months after treatment', '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'}, {'measure': 'urinary function', 'timeFrame': 'Day 0, Inclusion', '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)\n\nTranslated with www.DeepL.com/Translator (free version)'}, {'measure': 'urinary function', 'timeFrame': '6 months after treatment', '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)\n\nTranslated with www.DeepL.com/Translator (free version)'}, {'measure': 'urinary function', 'timeFrame': '12 months after treatment', '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)\n\nTranslated with www.DeepL.com/Translator (free version)'}, {'measure': 'urinary function', 'timeFrame': '18 months after treatment', '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)\n\nTranslated with www.DeepL.com/Translator (free version)'}, {'measure': 'urinary function', 'timeFrame': '24 months after treatment', '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)\n\nTranslated with www.DeepL.com/Translator (free version)'}, {'measure': 'urinary function', 'timeFrame': '30 months after treatment', '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)\n\nTranslated with www.DeepL.com/Translator (free version)'}, {'measure': 'urinary function', 'timeFrame': 'Day 0, Inclusion', 'description': 'Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:\n\nstress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)'}, {'measure': 'urinary function', 'timeFrame': '6 months after treatment', 'description': 'Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:\n\nstress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)'}, {'measure': 'urinary function', 'timeFrame': '12 months after treatment', 'description': 'Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:\n\nstress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)'}, {'measure': 'urinary function', 'timeFrame': '18 months after treatment', 'description': 'Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:\n\nstress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)'}, {'measure': 'urinary function', 'timeFrame': '24 months after treatment', 'description': 'Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:\n\nstress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)'}, {'measure': 'urinary function', 'timeFrame': '30 months after treatment', 'description': 'Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:\n\nstress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant)'}, {'measure': 'sexual fonction', 'timeFrame': 'Day 0, Inclusion', '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'}, {'measure': 'sexual fonction', 'timeFrame': '6 months after treatment', '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'}, {'measure': 'sexual fonction', 'timeFrame': '12 months after treatment', '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'}, {'measure': 'sexual fonction', 'timeFrame': '24 months after treatment', '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'}, {'measure': 'sexual fonction', 'timeFrame': '30 months after treatment', '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'}, {'measure': 'Evaluation of quality of life', 'timeFrame': 'Day 0, Inclusion', '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)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '6 months after treatment', '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)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '12 months after treatment', '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)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '18 months after treatment', '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)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '24 months after treatment', '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)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '30 months after treatment', '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)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': 'Day 0, Inclusion', '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)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '6 months after treatment', '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)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '12 months after treatment', '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)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '18 months after treatment', '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)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '24 months after treatment', '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)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '30 months after treatment', '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)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': 'Day 0, Inclusion', 'description': 'Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)\n\n1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy)\n\n1 (no problem) to 3 (unable) Questions 7 to 9 (current activities)\n\n1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort)\n\n1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression)\n\n1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '6 months after treatment', 'description': 'Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)\n\n1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy)\n\n1 (no problem) to 3 (unable) Questions 7 to 9 (current activities)\n\n1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort)\n\n1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression)\n\n1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '12 months after treatment', 'description': 'Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)\n\n1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy)\n\n1 (no problem) to 3 (unable) Questions 7 to 9 (current activities)\n\n1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort)\n\n1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression)\n\n1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '18 months after treatment', 'description': 'Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)\n\n1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy)\n\n1 (no problem) to 3 (unable) Questions 7 to 9 (current activities)\n\n1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort)\n\n1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression)\n\n1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '24 months after treatment', 'description': 'Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)\n\n1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy)\n\n1 (no problem) to 3 (unable) Questions 7 to 9 (current activities)\n\n1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort)\n\n1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression)\n\n1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': '30 months after treatment', 'description': 'Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)\n\n1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy)\n\n1 (no problem) to 3 (unable) Questions 7 to 9 (current activities)\n\n1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort)\n\n1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression)\n\n1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health)'}, {'measure': 'The rate of patients in biochemical failure', 'timeFrame': '6 weeks after treatment', 'description': 'The rate of patients in biochemical failure is measured by PSA dosage:\n\n* PSA \\> 0.2 ng for patients treated by radical surgery\n* PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU'}, {'measure': 'The rate of patients in biochemical failure', 'timeFrame': '3 months after treatment', 'description': 'The rate of patients in biochemical failure is measured by PSA dosage:\n\n* PSA \\> 0.2 ng for patients treated by radical surgery\n* PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU'}, {'measure': 'The rate of patients in biochemical failure', 'timeFrame': '6 months after treatment', 'description': 'The rate of patients in biochemical failure is measured by PSA dosage:\n\n* PSA \\> 0.2 ng for patients treated by radical surgery\n* PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU'}, {'measure': 'The rate of patients in biochemical failure', 'timeFrame': '12 months after treatment', 'description': 'The rate of patients in biochemical failure is measured by PSA dosage:\n\n* PSA \\> 0.2 ng for patients treated by radical surgery\n* PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU'}, {'measure': 'The rate of patients in biochemical failure', 'timeFrame': '18 months after treatment', 'description': 'The rate of patients in biochemical failure is measured by PSA dosage:\n\n* PSA \\> 0.2 ng for patients treated by radical surgery\n* PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU'}, {'measure': 'The rate of patients in biochemical failure', 'timeFrame': '24 months after treatment', 'description': 'The rate of patients in biochemical failure is measured by PSA dosage:\n\n* PSA \\> 0.2 ng for patients treated by radical surgery\n* PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU'}, {'measure': 'The rate of patients in biochemical failure', 'timeFrame': '30 months after treatment', 'description': 'The rate of patients in biochemical failure is measured by PSA dosage:\n\n* PSA \\> 0.2 ng for patients treated by radical surgery\n* PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU'}, {'measure': 'The rate of local recurrence', 'timeFrame': '3 months after treatment', 'description': 'The rate of local recurrence is measured by control biopsy (number of positive biopsies)'}, {'measure': 'Survival without metastases', 'timeFrame': '6 months after treatment', '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.'}, {'measure': 'Survival without metastases', 'timeFrame': '12 months after treatment', '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.'}, {'measure': 'Survival without metastases', 'timeFrame': '18 months after treatment', '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.'}, {'measure': 'Survival without metastases', 'timeFrame': '24 months after treatment', '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.'}, {'measure': 'Survival without metastases', 'timeFrame': '30 months after treatment', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIFU'], 'conditions': ['Prostate Cancer', 'Ultrasound Therapy']}, 'referencesModule': {'references': [{'pmid': '39632125', 'type': 'DERIVED', 'citation': 'Ploussard G, Coloby P, Chevallier T, Occean BV, Houede N, Villers A, Rischmann P; HIFI group. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. 2025 May;87(5):526-533. doi: 10.1016/j.eururo.2024.11.006. Epub 2024 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'to compare the efficacy of HIFU treatment with standard treatment in two situations:\n\n1. as first-line cancer treatment, HIFU is compared to radical prostatectomy.\n2. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'General inclusion criteria\n\n* Patients with localized adenocarcinoma of the prostate classified as T1-2, N0, Nx M0\n* classified as low or intermediate risk\n* Patient with PSA \\< 15 ng/ml, Gleason score ≤ 7 restricted to the form \\[3 + 4\\].\n* Biopsy with at least 12 specimens and a maximum of four out of six invaded sextants\n* Patient with a pelvic MRI if there is an intermediate risk and a bone scintigraphy if PSA \\> 10 ng/ml\n* Patient affiliated with health insurance or beneficiary of an equivalent plan\n\nInclusion criteria for the HIFU Arm\n\n* Patients 70 years of age or older\n* Patients with a life expectancy related to age and associated illness estimated to be greater than 5 years\n\nInclusion Criteria for Total Prostatectomy Arm\n\n• Patients with a life expectancy greater than 10 years and a state of health allowing general anaesthesia.\n\nNON-INCLUSION CRITERIA\n\n* Patient participating in other biomedical research within 3 months prior to their inclusion in this protocol\n* Included patient simultaneously participating in another research study'}, 'identificationModule': {'nctId': 'NCT04307056', 'acronym': 'HIFI', 'briefTitle': 'Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY', 'organization': {'class': 'OTHER', 'fullName': "Association Francaise d'Urologie"}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'HIFU/AFU/12.03'}, 'secondaryIdInfos': [{'id': '2013-A01042-43', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIFU', 'description': 'Patients Treated with high intensity focused ultrasound (HIFU)', 'interventionNames': ['Procedure: High Intensity Focused Ultrasound (HIFU) Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prostatectomy', 'description': 'Patients Treated by Radical Prostatectomy', 'interventionNames': ['Procedure: Radical Prostatectomy']}], 'interventions': [{'name': 'Radical Prostatectomy', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Prostatectomy']}, {'name': 'High Intensity Focused Ultrasound (HIFU) Treatment', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['HIFU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13616', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': "Centre Hospitalier d'Aix en Provence", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '69400', 'city': 'Arnas', 'country': 'France', 'facility': 'Polyckinique du Beaujolais', 'geoPoint': {'lat': 46.02361, 'lon': 4.7083}}, {'zip': '64100', 'city': 'Bayonne', 'country': 'France', 'facility': 'Clinique St Etienne', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHRU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '25044', 'city': 'Besançon', 'country': 'France', 'facility': 'Clinique St Vincent', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Clinique Tivoli-Ducos', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33074', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Clinique St Augustin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33200', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Nouvelle clinique Bel Air', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '73011', 'city': 'Chambéry', 'country': 'France', 'facility': 'CHR de Chambéry', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'country': 'France', 'facility': 'Pôle Santé Léonard de Vinci', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '63050', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'PôleSanté République', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'facility': 'Hôpitaux civils de Colmar', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Polyclinique du parc Drevon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '69130', 'city': 'Écully', 'country': 'France', 'facility': "Cliniqe du Val d'Ouest", 'geoPoint': {'lat': 45.77437, 'lon': 4.77758}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '07500', 'city': 'Guilherand-Granges', 'country': 'France', 'facility': 'Hôpital Privé Drome Ardèche', 'geoPoint': {'lat': 44.93278, 'lon': 4.87372}}, {'zip': '72018', 'city': 'Le Mans', 'country': 'France', 'facility': 'Cliique du Pré', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '43000', 'city': 'Le Puy-en-Velay', 'country': 'France', 'facility': 'Clinique Bon Secours', 'geoPoint': {'lat': 45.04366, 'lon': 3.88523}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59042', 'city': 'Lille', 'country': 'France', 'facility': 'Clinique La Louvière', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69002', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13008', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital St Joseph', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'AP-AM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34070', 'city': 'Montpellier', 'country': 'France', 'facility': 'Clinique Beau Soleil', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '68100', 'city': 'Mulhouse', 'country': 'France', 'facility': 'Clinique Diaconat-Roosevelt', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '06200', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75007', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation St Jean de Dieu - Clinique Oudinot', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75008', 'city': 'Paris', 'country': 'France', 'facility': 'Clinique Turin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital St Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital TENON', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75674', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75908', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Europeen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '95300', 'city': 'Pontoise', 'country': 'France', 'facility': 'CH de pontoise', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'Clinique Courlancy', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '44800', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Clinique Nantes Atlantis', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '17108', 'city': 'Saintes', 'country': 'France', 'facility': 'CH de Saintonge', 'geoPoint': {'lat': 45.74742, 'lon': -0.63489}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Clinique Rhéna', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '83000', 'city': 'Toulon', 'country': 'France', 'facility': 'Clinique St Michel', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31076', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31400', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique St Jean du Languedoc', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '56000', 'city': 'Vannes', 'country': 'France', 'facility': 'Clinique Océanne', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}, {'zip': '97159', 'city': 'Pointe-à-Pitre', 'country': 'Guadeloupe', 'facility': 'CHU de guadeloupe', 'geoPoint': {'lat': 16.23638, 'lon': -61.53459}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Association Francaise d'Urologie", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}