Evaluation of HIFU in TREATMENT OF LOCALIZED PROSTATE CANCER and OF RECURRENCE AFTER RADIOTHERAPY

Not Applicable

Completed

• Conditions: Prostate Cancer; Ultrasound Therapy

• 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

Study Timeline

• Study Start: 2015-03-23
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-13
• Primary Completion: 2022-08-24
• Study Completion: 2022-08-24
• Status Verified: 2022-11
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 3862

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 HIFU
urinary 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)

Centre Hospitalier d'Aix en Provence; 🇫🇷 Aix en Provence, France

Polyckinique du Beaujolais; 🇫🇷 Arnas, France

Clinique St Etienne; 🇫🇷 Bayonne, France

CHRU de Besançon; 🇫🇷 Besançon, France

Clinique St Vincent; 🇫🇷 Besançon, France

Clinique Tivoli-Ducos; 🇫🇷 Bordeaux, France

Clinique St Augustin; 🇫🇷 Bordeaux, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Nouvelle clinique Bel Air; 🇫🇷 Bordeaux, France

Pôle Santé Léonard de Vinci; 🇫🇷 Chambray-lès-Tours, France

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