At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A clinical study evaluating Radical Prostatectomy and High Intensity Focused Ultrasound (HIFU) Treatment for Prostate Cancer and Ultrasound Therapy. Completed, enrolled 3,862 participants across 49 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.