MP62-05 MAGNETIC RESONANCE IMAGING (MRI)-GUIDED TRANSURETHRAL ULTRASOUND ABLATION OF PROSTATE CANCER: PRELIMINARY OUTCOMES OF A PHASE I CLINICAL TRIAL

Abstract

You have accessJournal of UrologyProstate Cancer: Localized VII1 Apr 2014MP62-05 MAGNETIC RESONANCE IMAGING (MRI)-GUIDED TRANSURETHRAL ULTRASOUND ABLATION OF PROSTATE CANCER: PRELIMINARY OUTCOMES OF A PHASE I CLINICAL TRIAL Michele Billia, Mathieu Burtnyk, Timur Kuru, Sascha Pahernik, Matthias Roethke, Heinz-Peter Schlemmer, Cesare Romagnoli, and Joseph Chin Michele BilliaMichele Billia More articles by this author , Mathieu BurtnykMathieu Burtnyk More articles by this author , Timur KuruTimur Kuru More articles by this author , Sascha PahernikSascha Pahernik More articles by this author , Matthias RoethkeMatthias Roethke More articles by this author , Heinz-Peter SchlemmerHeinz-Peter Schlemmer More articles by this author , Cesare RomagnoliCesare Romagnoli More articles by this author , and Joseph ChinJoseph Chin More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1962AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES MRI-guided transurethral ultrasound ablation (TULSA) is a new minimally-invasive technology for treatment of localized prostate cancer (PCa), aiming to provide good local disease control with a low side-effect profile. This modality consists of a transurethral device emitting planar ultrasound and generating a continuous and precise volume of thermal coagulation shaped to conform to the prostate, using real-time MRI monitoring and active temperature feedback control. A prospective, multi-center phase I clinical trial was initiated in March 2013 with the aim to determine safety and feasibility of MRI-guided TULSA, and to assess initial efficacy for localized PCa treatment. METHODS Patients with low-risk PCa: cT1c-T2a, N0, M0; PSA≤10ng/ml; GS≤6 are enrolled. Under general anesthesia, suprapubic catheter (SPC) is inserted and left in for 2 weeks. The TULSA device (PAD-105, Profound Medical Inc.) is inserted manually over a Nitinol guidewire and positioned precisely in the prostatic urethra with MRI guidance (3-Tesla unit). Treatment planning is performed under MRI prostate visualization, with therapeutic intent of conservative whole-gland ablation. Treatment is delivered under continuous MR thermometry feedback control, and patients recover with an outpatient protocol. Primary study endpoints are safety and feasibility, with follow-up to 12 months. Complete clinical monitoring is 5 years, including serial PSA, TRUS biopsy and QoL questionnaires (IPSS, IIEF, bowel domain of UCLA-PCI-SF). RESULTS To-date, 17 patients have been treated with no intraoperative complications. Median treatment time was 29 (24 – 61) min and prostate volume 45 (34 – 95) cc. Spatial control of thermal ablation was within ±1.5 mm and contrast-enhanced MRI confirmed the resulting non-perfused volume. Clavien II complications included urinary tract infections (4), and epididymitis (1). Clavien I complications included hematuria (3), and acute urinary retention after SPC removal (2) resolving after SPC re-insertion. At 1 month, median PSA reduced by 87% (60 – 99%) to 0.7 ng/ml (0.1 – 3.3 ng/ml), with the nadir expected by 6 months. Normal micturition returned after SPC removal, with no significant change in QoL at 3 months. CONCLUSIONS MRI-guidance enables accurate planning and real-time dosimetry and control of the thermal ablation volume. Initial results indicate that MRI-guided TULSA is safe and clinically feasible with a well-tolerated, low side effect profile. © 2014FiguresReferencesRelatedDetailsCited byBurtnyk M, Hill T, Cadieux-Pitre H and Welch I (2018) Magnetic Resonance Image Guided Transurethral Ultrasound Prostate Ablation: A Preclinical Safety and Feasibility Study with 28-Day FollowupJournal of Urology, VOL. 193, NO. 5, (1669-1675), Online publication date: 1-May-2015. Volume 191Issue 4SApril 2014Page: e718-e719 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Michele Billia More articles by this author Mathieu Burtnyk More articles by this author Timur Kuru More articles by this author Sascha Pahernik More articles by this author Matthias Roethke More articles by this author Heinz-Peter Schlemmer More articles by this author Cesare Romagnoli More articles by this author Joseph Chin More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...