Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY
- Conditions
- Prostate CancerUltrasound Therapy
- Interventions
- Procedure: High Intensity Focused Ultrasound (HIFU) TreatmentProcedure: Radical Prostatectomy
- Registration Number
- NCT04307056
- Lead Sponsor
- Association Francaise d'Urologie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 3862
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HIFU High Intensity Focused Ultrasound (HIFU) Treatment Patients Treated with high intensity focused ultrasound (HIFU) Prostatectomy Radical Prostatectomy Patients Treated by Radical Prostatectomy
- Primary Outcome Measures
Name Time Method Recurrence-free survival 30 months 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
Name Time Method Survival without metastases 30 months after treatment demonstrated by an additional assessment (CT scan and bone scintigraphy, supplemented by MRI in case of suspicious anomaly), recorded on the date of diagnosis.
The rate of local recurrence 3 months after treatment The rate of local recurrence is measured by control biopsy (number of positive biopsies)
Immediate or late complications Day 0, Inclusion clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
immediate or late complications 30 months after treatment clinical observations (Stenosis, bleeding, hemorrhoids, urinary infections ...)
Evaluation of quality of life 30 months after treatment 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 30 months after treatment 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 HIFUurinary function 30 months after treatment 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 30 months after treatment 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
Trial Locations
- Locations (48)
Clinique St Etienne
🇫🇷Bayonne, France
CHU de Bordeaux
🇫🇷Bordeaux, France
Nouvelle clinique Bel Air
🇫🇷Bordeaux, France
CHR de Chambéry
🇫🇷Chambéry, France
CHU de Dijon
🇫🇷Dijon, France
CHU de Grenoble
🇫🇷Grenoble, France
Cliique du Pré
🇫🇷Le Mans, France
Hôpital Privé Drome Ardèche
🇫🇷Guilherand-Granges, France
CHRU de Lille
🇫🇷Lille, France
Clinique Bon Secours
🇫🇷Le Puy-en-Velay, France
CHU de Limoges
🇫🇷Limoges, France
Hospices Civils de lyon
🇫🇷Lyon, France
AP-AM
🇫🇷Marseille, France
Clinique Beau Soleil
🇫🇷Montpellier, France
Clinique Diaconat-Roosevelt
🇫🇷Mulhouse, France
CHU de Nice
🇫🇷Nice, France
CHU de Nîmes
🇫🇷Nîmes, France
Fondation St Jean de Dieu - Clinique Oudinot
🇫🇷Paris, France
Clinique Turin
🇫🇷Paris, France
Hôpital TENON
🇫🇷Paris, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
Hôpital Europeen Georges Pompidou
🇫🇷Paris, France
Clinique Courlancy
🇫🇷Reims, France
Clinique Nantes Atlantis
🇫🇷Saint-Herblain, France
CH de pontoise
🇫🇷Pontoise, France
CHU de rennes
🇫🇷Rennes, France
Clinique Rhéna
🇫🇷Strasbourg, France
Hôpital Foch
🇫🇷Suresnes, France
CH de Saintonge
🇫🇷Saintes, France
Clinique St Michel
🇫🇷Toulon, France
Clinique Pasteur
🇫🇷Toulouse, France
CHU de guadeloupe
🇬🇵pointe-à -Pitre, Guadeloupe
CHRU de Besançon
🇫🇷Besançon, France
CHU de Toulouse
🇫🇷Toulouse, France
Clinique St Augustin
🇫🇷Bordeaux, France
Clinique St Vincent
🇫🇷Besançon, France
Clinique Tivoli-Ducos
🇫🇷Bordeaux, France
Hôpitaux civils de Colmar
🇫🇷Colmar, France
Hôpital St Joseph
🇫🇷Paris, France
Centre Hospitalier d'Aix en Provence
🇫🇷Aix en Provence, France
Polyckinique du Beaujolais
🇫🇷Arnas, France
Polyclinique du parc Drevon
🇫🇷Dijon, France
Pôle Santé Léonard de Vinci
🇫🇷Chambray-lès-Tours, France
PôleSanté République
🇫🇷Clermont-Ferrand, France
Clinique La Louvière
🇫🇷Lille, France
Clinique Océanne
🇫🇷Vannes, France
Cliniqe du Val d'Ouest
🇫🇷Écully, France
Clinique St Jean du Languedoc
🇫🇷Toulouse, France