Prostate cancer treatment by the latest focal HIFU device with MRI/TRUS-fusion control biopsies: A prospective evaluation

Magnetic resonance imaging/transrectal ultrasound (MRI/TRUS) fusion-guided focal high intensity focused ultrasound (HIFU) therapy of the prostate has recently been developed as a selective HIFU-therapy technique to enable targeted ablation of prostate cancer. Here we report a series of patients treated with focal HIFU therapy, discuss its potential pitfalls, and address controversies concerning the indications.

This single-center prospective study reports outcomes of patients treated from September 2014 to March 2016. Follow-up was a minimum of 12 months. MRI/TRUS-fusion-guided HIFU was performed under general anesthesia using the Focal One® device (EDAP, France). A control biopsy at 12 months was taken using the MRI/TRUS-fusion biopsy platform Artemis™ (Eigen, California) combining targeted and systematic cores. Prostate-specific antigen (PSA) changes from baseline, patient-reported outcome measures, and complications using the Clavien-Dindo classification system are also reported.

Twenty-four patients (PSA < 10 ng/ml, n = 17 Gleason 3+3, n = 7 Gleason 3+4) with either unifocal or bifocal prostate imaging reporting and data system (PI-RADS) 3-5 lesions (n = 19) or without a PI-RADS lesion (n = 5) were treated. Nineteen patients underwent focal HIFU, five patients zonal HIFU. Of the 20 patients that had biopsies at 12 months, 8 patients had a positive biopsy within the ablation zone (overall cancer free rate: 60%). Using different definitions of clinically significant cancer, the cancer-free rate for the ablation zone varies between 75% and 95%. Four of the eight patients (all persistent Gleason 3+4 or upgrading to 4+3) underwent a radical whole gland salvage therapy. Patient-reported outcome measures showed no significant decrease in urinary continence (expanded prostate cancer index composite -26 urinary incontinence: P = 0.080), but there was a reduction in potency (International index of erectile function in preoperatively potent patients: median decrease of 2 points to a median of 19 points at 12 months; 95% confidence interval: 15.79-22.21; P = 0.044). Only one complication > grade II occurred.

Targeted MRI/TRUS fusion-guided focal HIFU allows local tumor ablation, but is not free from limitations. The procedure has good functional outcomes and a quick recovery. Multicenter trials with more patients are required to determine the procedure´s role in the prostate cancer therapy algorithm.

Urologic oncology. 2018 Aug 06 [Epub ahead of print]

Jost von Hardenberg, Niklas Westhoff, Daniel Baumunk, Daniel Hausmann, Thomas Martini, Alexander Marx, Stefan Porubsky, Martin Schostak, Maurice Stephan Michel, Manuel Ritter

Department of Urology, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany. Electronic address: ., Department of Urology, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany., Department of Urology and Pediatric Urology, University Hospital Magdeburg, Leipziger Str. 44, 39120 Magdeburg Germany., Institute of Clinical Radiology and Nuclear Medicine, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany., Department of Urology, University Hospital Ulm, Prittwitzstraße 43, 89075 Ulm, Germany., Institute of Pathology, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, Heidelberg, Germany.