Prostate Cancer Clinical Trial
— HIFIOfficial 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)
Verified date | November 2022 |
Source | Association Francaise d'Urologie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
to compare the efficacy of HIFU treatment with standard treatment in two situations: 1. as first-line cancer treatment, HIFU is compared to radical prostatectomy. 2. for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.
Status | Completed |
Enrollment | 3862 |
Est. completion date | August 24, 2022 |
Est. primary completion date | August 24, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 70 Years and older |
Eligibility | General inclusion criteria - Patients with localized adenocarcinoma of the prostate classified as T1-2, N0, Nx M0 - classified as low or intermediate risk - Patient with PSA < 15 ng/ml, Gleason score = 7 restricted to the form [3 + 4]. - Biopsy with at least 12 specimens and a maximum of four out of six invaded sextants - Patient with a pelvic MRI if there is an intermediate risk and a bone scintigraphy if PSA > 10 ng/ml - Patient affiliated with health insurance or beneficiary of an equivalent plan Inclusion criteria for the HIFU Arm - Patients 70 years of age or older - Patients with a life expectancy related to age and associated illness estimated to be greater than 5 years Inclusion Criteria for Total Prostatectomy Arm • Patients with a life expectancy greater than 10 years and a state of health allowing general anaesthesia. NON-INCLUSION CRITERIA - Patient participating in other biomedical research within 3 months prior to their inclusion in this protocol - Included patient simultaneously participating in another research study |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier d'Aix en Provence | Aix en Provence | |
France | Polyckinique du Beaujolais | Arnas | |
France | Clinique St Etienne | Bayonne | |
France | CHRU de Besançon | Besançon | |
France | Clinique St Vincent | Besançon | |
France | CHU de Bordeaux | Bordeaux | |
France | Clinique St Augustin | Bordeaux | |
France | Clinique Tivoli-Ducos | Bordeaux | |
France | Nouvelle clinique Bel Air | Bordeaux | |
France | CHR de Chambéry | Chambéry | |
France | Pôle Santé Léonard de Vinci | Chambray-lès-Tours | |
France | PôleSanté République | Clermont-Ferrand | |
France | Hôpitaux civils de Colmar | Colmar | |
France | CHU de Dijon | Dijon | |
France | Polyclinique du parc Drevon | Dijon | |
France | Cliniqe du Val d'Ouest | Écully | |
France | CHU de Grenoble | Grenoble | |
France | Hôpital Privé Drome Ardèche | Guilherand-Granges | |
France | Cliique du Pré | Le Mans | |
France | Clinique Bon Secours | Le Puy-en-Velay | |
France | CHRU de Lille | Lille | |
France | Clinique La Louvière | Lille | |
France | CHU de Limoges | Limoges | |
France | Hospices Civils de lyon | Lyon | |
France | AP-AM | Marseille | |
France | Hôpital St Joseph | Marseille | |
France | Clinique Beau Soleil | Montpellier | |
France | Clinique Diaconat-Roosevelt | Mulhouse | |
France | CHU de Nice | Nice | |
France | CHU de Nîmes | Nîmes | |
France | Clinique Turin | Paris | |
France | Fondation St Jean de Dieu - Clinique Oudinot | Paris | |
France | Hôpital Europeen Georges Pompidou | Paris | |
France | Hôpital St Joseph | Paris | |
France | Hôpital TENON | Paris | |
France | Institut Mutualiste Montsouris | Paris | |
France | CH de pontoise | Pontoise | |
France | Clinique Courlancy | Reims | |
France | CHU de rennes | Rennes | |
France | Clinique Nantes Atlantis | Saint-Herblain | |
France | CH de Saintonge | Saintes | |
France | Clinique Rhéna | Strasbourg | |
France | Hôpital Foch | Suresnes | |
France | Clinique St Michel | Toulon | |
France | CHU de Toulouse | Toulouse | |
France | Clinique Pasteur | Toulouse | |
France | Clinique St Jean du Languedoc | Toulouse | |
France | Clinique Océanne | Vannes | |
Guadeloupe | CHU de guadeloupe | pointe-à-Pitre |
Lead Sponsor | Collaborator |
---|---|
Association Francaise d'Urologie |
France, Guadeloupe,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence-free survival | The main objective for patients is to compare recurrence-free survival (i.e., the rate of salvage therapy by external beam radiotherapy and/or hormone therapy) in patients treated by HIFU and those treated by radical prostatectomy. The implementation of salvage therapy will be decided according to several non-exclusive criteria (positivity of margins (for patients with radical prostatectomy), PSA at 3 months, biologic recurrence (increase in PSA > 0.2 ng/ml after radical surgery, > Nadir +2 after HIFU), control biopsies positive, the appearance of metastases | 30 months | |
Secondary | Immediate or late complications | clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...) | 6 weeks after treatment | |
Secondary | Immediate or late complications | clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...) | Day 0, Inclusion | |
Secondary | immediate or late complications | clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...) | 3 months after treatment | |
Secondary | immediate or late complications | clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...) | 6 months after treatment | |
Secondary | immediate or late complications | clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...) | 12 months after treatment | |
Secondary | immediate or late complications | clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...) | 18 months after treatment | |
Secondary | immediate or late complications | clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...) | 24 months after treatment | |
Secondary | immediate or late complications | clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...) | 30 months after treatment | |
Secondary | urinary function | measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort | Day 0, Inclusion | |
Secondary | urinary function | measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort | 6 months after treatment | |
Secondary | urinary function | measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort | 12 months after treatment | |
Secondary | urinary function | measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort | 24 months after treatment | |
Secondary | urinary function | measured by the International Prostate Symptom score (IPSS). For the first seven questions: 0 to 7: mild disorders, 8 to 19: moderate disorders, 20 to 35: severe disorders For quality of life question 8: Score from 0 to 6: 0 no discomfort, 6 very discomfort | 30 months after treatment | |
Secondary | urinary function | Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more)
Translated with www.DeepL.com/Translator (free version) |
Day 0, Inclusion | |
Secondary | urinary function | Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more)
Translated with www.DeepL.com/Translator (free version) |
6 months after treatment | |
Secondary | urinary function | Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more)
Translated with www.DeepL.com/Translator (free version) |
12 months after treatment | |
Secondary | urinary function | Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more)
Translated with www.DeepL.com/Translator (free version) |
18 months after treatment | |
Secondary | urinary function | Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more)
Translated with www.DeepL.com/Translator (free version) |
24 months after treatment | |
Secondary | urinary function | Urinary function measured by the International Continence Society score (ICS score). Question 1: Stress incontinence Score (frequency) from 0 to 4 (never - always) Sub-score 1a (quality of life) from 0 to 3 (none - significant discomfort) Question 2: Insensitive incontinence Score (frequency) from 0 to 4 (never - always) Sub score 2 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 3: Incontinence at night Score (frequency) from 0 to 4 (never - always) Sub score 3 bis (quality of life) from 0 to 3 (none - significant discomfort) Question 4: Change of clothing or protective wear Score from 0 to 4 (no leakage of urine - seal port) Sub-score 4 bis (quality of life) from 0 to 3 (no significant discomfort to major discomfort) Question 5: Number of protection used Day Score: 0 to 4 (none to 6 or more) Score at night: 0 to 4 (none to 6 or more)
Translated with www.DeepL.com/Translator (free version) |
30 months after treatment | |
Secondary | urinary function | Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:
stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant) |
Day 0, Inclusion | |
Secondary | urinary function | Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:
stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant) |
6 months after treatment | |
Secondary | urinary function | Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:
stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant) |
12 months after treatment | |
Secondary | urinary function | Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:
stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant) |
18 months after treatment | |
Secondary | urinary function | Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:
stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant) |
24 months after treatment | |
Secondary | urinary function | Urinary function measured by the Urinary Symptom Score(USP). 3 sub-scores:
stress urinary incontinence score: 0 to 9 (none - significant) OAB score: 0 to 21(none - significant) Dysuria score: 0 to 9 (none - significant) |
30 months after treatment | |
Secondary | sexual fonction | Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function | Day 0, Inclusion | |
Secondary | sexual fonction | Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function | 6 months after treatment | |
Secondary | sexual fonction | Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function | 12 months after treatment | |
Secondary | sexual fonction | Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function | 24 months after treatment | |
Secondary | sexual fonction | Sexual function results are measured by the International Index Erectile Function score (IIEF-5). score from 1 to 4: not interpretable score from 5 to 10: severe erectile dysfunction score from 11 to 15: moderate erectile dysfunction score from 16 to 20: mild erectile dysfunction score from 21 to 25: normal erectile function | 30 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent) | Day 0, Inclusion | |
Secondary | Evaluation of quality of life | Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent) | 6 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent) | 12 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent) | 18 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent) | 24 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by EORTC-QLQ-C30. Questions 1 to 28 (general) score from 0 to 4 for each question (not at all to many) Question 29 (health status) score from 1 to 7 (very bad to excellent) Question 30 (quality of life) score from 1 to 7 (very bad to excellent) | 30 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many) | Day 0, Inclusion | |
Secondary | Evaluation of quality of life | Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many) | 6 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many) | 12 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many) | 18 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many) | 24 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by PR 25. Questions 1 to 9 (urinary disorders) score from 0 to 4 for each question (none to many) Questions 10 to 13 (intestinal disorders) score from 0 to 4 for each question (none to many) Question 14 (hot flashes) score from 0 to 4 for each question (none to many) Question 15 (gynecomastia) score from 0 to 4 for each question (none to many) Question 16 (swollen legs) score from 0 to 4 for each question (none to many) Questions 17 to 18 (weight gain or loss) score from 0 to 4 for each question (none to many) Questions 19 to 25 (sexuality) score from 0 to 4 for each question (none to many) | 30 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)
1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy) 1 (no problem) to 3 (unable) Questions 7 to 9 (current activities) 1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort) 1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression) 1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health) |
Day 0, Inclusion | |
Secondary | Evaluation of quality of life | Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)
1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy) 1 (no problem) to 3 (unable) Questions 7 to 9 (current activities) 1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort) 1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression) 1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health) |
6 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)
1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy) 1 (no problem) to 3 (unable) Questions 7 to 9 (current activities) 1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort) 1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression) 1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health) |
12 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)
1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy) 1 (no problem) to 3 (unable) Questions 7 to 9 (current activities) 1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort) 1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression) 1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health) |
18 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)
1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy) 1 (no problem) to 3 (unable) Questions 7 to 9 (current activities) 1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort) 1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression) 1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health) |
24 months after treatment | |
Secondary | Evaluation of quality of life | Quality of life measured by the 3-level version of EQ-5D. Questions 1 to 3 (mobility)
1 (no problem) to 3 (unable) Questions 4 to 6 (personal autonomy) 1 (no problem) to 3 (unable) Questions 7 to 9 (current activities) 1 (no problem) to 3 (unable) Questions 10 to 12 (pain/discomfort) 1 (none) to 3 (extreme) Questions 13 to 15 (anxiety/depression) 1 (none) to 3 (extreme) Question 16 (health status) Scale from 0 to 100 (worse health to better health) |
30 months after treatment | |
Secondary | The rate of patients in biochemical failure | The rate of patients in biochemical failure is measured by PSA dosage:
PSA > 0.2 ng for patients treated by radical surgery PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU |
6 weeks after treatment | |
Secondary | The rate of patients in biochemical failure | The rate of patients in biochemical failure is measured by PSA dosage:
PSA > 0.2 ng for patients treated by radical surgery PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU |
3 months after treatment | |
Secondary | The rate of patients in biochemical failure | The rate of patients in biochemical failure is measured by PSA dosage:
PSA > 0.2 ng for patients treated by radical surgery PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU |
6 months after treatment | |
Secondary | The rate of patients in biochemical failure | The rate of patients in biochemical failure is measured by PSA dosage:
PSA > 0.2 ng for patients treated by radical surgery PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU |
12 months after treatment | |
Secondary | The rate of patients in biochemical failure | The rate of patients in biochemical failure is measured by PSA dosage:
PSA > 0.2 ng for patients treated by radical surgery PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU |
18 months after treatment | |
Secondary | The rate of patients in biochemical failure | The rate of patients in biochemical failure is measured by PSA dosage:
PSA > 0.2 ng for patients treated by radical surgery PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU |
24 months after treatment | |
Secondary | The rate of patients in biochemical failure | The rate of patients in biochemical failure is measured by PSA dosage:
PSA > 0.2 ng for patients treated by radical surgery PSA nadir +2 ng/mL (Phoenix criteria) for patients treated by HIFU |
30 months after treatment | |
Secondary | The rate of local recurrence | The rate of local recurrence is measured by control biopsy (number of positive biopsies) | 3 months after treatment | |
Secondary | Survival without metastases | demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis. | 6 months after treatment | |
Secondary | Survival without metastases | demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis. | 12 months after treatment | |
Secondary | Survival without metastases | demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis. | 18 months after treatment | |
Secondary | Survival without metastases | demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis. | 24 months after treatment | |
Secondary | Survival without metastases | demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis. | 30 months after treatment |
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