Focal treatment of prostate cancer using Focal One device: Pilot study results.

Abstract

112 Background: To evaluate the efficacy of Focal One device for focal treatment of localized prostate cancer. Methods: Focal One is a device designed for the focal therapy of Prostate Cancer integrating the ability to visualize, target, treat and validate the focal treatment. Magnetic Resonnance Imaging (MRI) volumes are imported through the hospital’s network into the device so that an elastic fusion can be done between the real time ultrasonography and the MRI where the regions to treat have been previousy drawn, thus allowing to apply limited and targeted HIFU lesions. During the HIFU energy delivery process, the operator sees a live ultrasound image of what is being treated and, if necessary, can readjust the treatment planning. At the end of the treatment process, a Contrast-enhanced Ultrasound volume is acquired showing the de-vascularized areas. Ten patients with mono focal prostate cancer were treated between march 2013 and January 2014.HIFU treatment process was realized with the Focal One device using a 6 mm safety margin around the tumor. Contrast enhanced MRI is performed at day 2 after HIFU and Control biopsies guided with contrast-enhanced Ultrasound imaging were achieved one month after HIFU inside and in the rime of the treated area. Results: The mean age of patients was 65.8±5.5 years. The Clinical stage was T1for 9 patients and T2afor 1patient.The Gleason sum was 6 for 7 patients and 7(3+4) for 3 patients. The PSA value was 4.47± 3.7 ng/ml and the mean Prostate Volume was 50±23 cc .The mean treated volume was 14 cc (7.3-20.4) 28% of prostate gland. The mean nadir PSA value was 3.46±2 ng/ml. In all patients, targeted biopsies inside the treated area performed day 30 after the HIFU session demonstrated a complete destruction of the targeted tumor. No Incontinence was observed .A partial loss of potency (IIEF <17) occurred in 2 patients. Conclusions: Focal One device is able to achieve a complete destruction of small prostate cancer using an elastic magnetic resonance-ultrasound (MR-US) registration system for tumor location and HIFU treatment planning. Multicenter trial is in progress (30 patients).