MRI/real-time ultrasound image fusion guided high-intensity focused ultrasound: a prospective comparative and functional analysis of different ablative techniques

Abstract

Background: The aim of this paper was to compare safety and functional outcomes of total, hemi and focal ablation by the latest focal high-intensity focused ultrasound (HIFU) device.

Methods: This is a prospective study including patients with low to intermediate-risk PCa treated with HIFU by Focal One^® device from 11/2018 to 3/2020. Before the treatment all patients underwent mp-magnetic resonance imaging (MRI) and subsequent MRI/transrectal ultrasound (TRUS) fusion and standard biopsy. Patients were stratified according to the type of ablation: total, hemi- or focal ablation. Functional data (IPSS, Quality of Life [QoL], IIEF-5, maximum flow [Qmax] and post void residual [PVR] at flowmetry) were assessed preoperatively and at 1, 3, 6 and 12 months after treatment. Moreover, the urinary symptoms reported by patients at IPSS questionnaire were divided in "irritative" and "obstructive" and compared.

Results: One hundred patients were enrolled. Median prostate volume and lesion diameter were 46 (IQR 25-75) mL and 10 (IQR 6-13) mm. 15, 50 and 35 patients underwent total, hemi- and focal ablation, respectively. No differences were found between them except for operative time (lower in the focal group, P<0.01). Significant lower incidence of irritative symptoms was identified in the focal group compared to the others (P<0.05 at 1 and 3 months of follow-up). No differences were found among the baseline status and the postoperative assessment in terms of obstructive IPSS items, IIEF-5, QoL, Qmax and PVR (all P value>0.05).

Conclusions: Our study suggests that patients' specific HIFU tailoring with the MRI/real-time TRUS Guidance by Focal One^® device is able to minimize the side effects of treatment.