Login to Access Video or Poster Abstract: MP70-10
Sources of Funding: none

Introduction

Focal therapy is an emerging mini-invasive treatment modality for localized prostate cancer (PCa) aimed to reduce the morbidity associated with radical therapy while maintaining optimal cancer control. The technological improvement of multiparametric magnetic resonance imaging (mpMRI), 3D-ultrasound and software for image fusion in order to locate more accurately PCa foci provides an optimal technology combination for the ideal focal efficacy. We report the 6-months oncological and functional results of primary focal ablation high-intensity focused ultrasound (HIFU) after fusion biopsy diagnosis of PCa in a prospective cohort of patients.

Methods

Single-center prospective evaluation of focal therapy for organ-confined PCa was performed from November 2015 through April 2016 using Focal-One® device (EDAP TMS). PCa diagnosis and localization was done based on mpMRI and -3D ultrasound-targeted fusion biopsy (Trinity, Koelis) plus standard biopsy. HIFU focal ablation using Focal-One® device was carried out under general anesthesia to immobilize the target lesion. The MRI/US imaging fusion of the target area was transported directely from Trinity to Focal One through specific software for the treatment. Treatment oncologic outcomes were evaluated with PSA and mpMRI 6 months after treatment. Targeted fusion biopsy after HIFU treatment was performed only in mpMRI positive patients. Functional outcomes were assessed with validated questionnaires for genitourinary symptoms.

Results

Forty-one patients underwent focal therapy and were included in the study. Mean age was 70 yr (55-79 yr). Mean PSA was 6.8 ng/ml (0.5-18). National Comprehensive Cancer Network low-, intermediate-, and high-risk disease was 29 (70,8%), 10 (24,4%), and 2 (5,8%), respectively. Mean pre-treatment prostate volume was 39,7 ml (14-66); Mean volume of tissue treated was 13,5 ml (4-30). In three patients a ThuLEP procedure was performed 2 months before HIFU. In thirty-three patients (80,3%) the catheter was removed in day 7 after HIFU; in eight patients (19,5%) the catheter was maintained until day 15. Nine men (21,9%) had self-resolving, mild to moderate, dysuria (median duration 7 days). Urinary tract infection was noted in 5 men (12,2%). Mean 6-months PSA was 2,4 ng/ml (0,2-9). Forthy patients (97,6%) had normal mpMRI findings 6-months after HIFU. One patient showed focal abnormal signal at mpMRI around the treated area: fusion biopsies confirmed the persistence of microfocal PCa with Gleason score 3+3 (treatment failure); in this patients a retreatment was performed. No major complication was observed. IPSS score showed no significant difference before and 6-months after HIFU. At 6 months, all patients were completely continent, and potency was maintained in 30 of 31 preoperatively potent patients.

Conclusions

The integration between fusion biopsy and Focal One device allows to date the most accurate detection and treatment of index focus of PCa. This preliminary experience with 6-months follow-up time indicates that HIFU focal ablation of prostate cancer leads to &[Prime]Trifecta&[Prime] outcomes (cancer control, continence, sexual potency) in 91,5% of 41 men. The integration of new technologies enables the accurate and early diagnosis of recurrence after focal ablative treatment, leaving the possibility of a precise HIFU retreatment.

Funding

none