MP70-16 SAFETY AND FEASIBILITY OF REAL-TIME MRI-GUIDED FOCUSED ULTRASOUND FOR FOCAL THERAPY OF LOCALIZED PROSTATE CANCER USING THE EXABLATE 2100 DEVICE: PHASE 1 STUDY

Abstract

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy I1 Apr 2017MP70-16 SAFETY AND FEASIBILITY OF REAL-TIME MRI-GUIDED FOCUSED ULTRASOUND FOR FOCAL THERAPY OF LOCALIZED PROSTATE CANCER USING THE EXABLATE 2100 DEVICE: PHASE 1 STUDY Nathan Perlis, Eugen Hlasny, Walter Kucharczyk, Masoom Haider, Antonio Finelli, Alexandre Zlotta, Girish Kulkarni, John Trachtenberg, and Sangeet Ghai Nathan PerlisNathan Perlis More articles by this author , Eugen HlasnyEugen Hlasny More articles by this author , Walter KucharczykWalter Kucharczyk More articles by this author , Masoom HaiderMasoom Haider More articles by this author , Antonio FinelliAntonio Finelli More articles by this author , Alexandre ZlottaAlexandre Zlotta More articles by this author , Girish KulkarniGirish Kulkarni More articles by this author , John TrachtenbergJohn Trachtenberg More articles by this author , and Sangeet GhaiSangeet Ghai More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2292AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Organ preserving therapy is emerging as an option for localized prostate cancer to minimize the morbidity associated with whole-gland therapy. We examine the short-term oncologic and functional data of the initial phase 1 trial of patients treated with focal transrectal MRI-guided focused ultrasound (MRgFUS) in North America. METHODS This phase 1 prospective study was approved by institutional review board. Eight patients with organ-confined PC visible on multiparametric MRI (mpMRI) and confirmed by the MRI-fusion biopsy (Artemis, Eigen) were enrolled. Patients were eligible with PSA ≤10ng/mL and Gleason score (GS) ≤ 7(4+3). Tumors larger than 1.5 cm in any dimension, too peripheral for a 5mm ablation margin or with concern for extraprostatic extension were excluded. Under MRI-guidance and real-time MR thermography, focal lesions were ablated using high frequency ultrasound energy delivered via an endorectal transducer with 990 elements (ExAblate 2100, InSightec). Incidence and severity of treatment-related adverse events were recorded at 6 months. RESULTS Eight patients with 10 peripheral zone lesions were treated. Prostate volume ranged from 25 to 50 cc with mean target volume of 2.7cc (range 0.4 - 5.7cc). Mean procedure time was 248 minutes. Based on pre-treatment biopsy, six lesions were GS6(3+3), two were GS7(3+4) and two others were GS7(4+3). Treatments were all completed as planned without major technical delays or surgical complications. Mean post treatment non-perfused volume was 4.3cc (range 2.2 - 7.6cc). Quality of life parameters were similar between baseline and 6-months in 6 of 8 patients. One patient with bilateral ablation had significantly worse storage symptoms while a second patient developed self-limiting acute prostatitis with erectile dysfunction. Mean PSA decreased from 5.06 to 3.4 ng/ml at 6 months. All patients were MRI negative in their treated regions. On biopsy, five patients were disease-free in treated regions (7 of 10 lesions). In one patient with a presumed GS7(4+3) tumor, a 2mm MRI-invisible focus of GS8(4+4) PC was seen in 1 of 5 cores from the ablation site. He underwent prostatectomy with negative surgical margins. CONCLUSIONS MRgFUS is a feasible and safe method of ablating localized PC. Further work is required to improve patient selection and address causes of failed ablation. Our study is limited by small sample size and brief follow-up. More meaningful oncologic and functional outcomes for MRgFUS can be assessed with larger trials with longer follow-up. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e941 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Nathan Perlis More articles by this author Eugen Hlasny More articles by this author Walter Kucharczyk More articles by this author Masoom Haider More articles by this author Antonio Finelli More articles by this author Alexandre Zlotta More articles by this author Girish Kulkarni More articles by this author John Trachtenberg More articles by this author Sangeet Ghai More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...