Mp25-17 Initial Experience With Mri-Guided Transurethral Ultrasound Ablation (Tulsa) in Men With Localized Prostate Cancer

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy I (MP25)1 May 2024MP25-17 INITIAL EXPERIENCE WITH MRI-GUIDED TRANSURETHRAL ULTRASOUND ABLATION (TULSA) IN MEN WITH LOCALIZED PROSTATE CANCER Ethan Wajswol, Ram Pathak, Gregory Frey, David Sella, and Chandler Dora Ethan WajswolEthan Wajswol , Ram PathakRam Pathak , Gregory FreyGregory Frey , David SellaDavid Sella , and Chandler DoraChandler Dora View All Author Informationhttps://doi.org/10.1097/01.JU.0001008692.26556.39.17AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: MRI-guided transurethral ultrasound ablation (TULSA) uses directional ultrasound and real-time MR thermometry-based control to thermally coagulate a prescribed volume of prostate tissue. Here we report our initial experience as the first US academic center to offer TULSA to prostate cancer patients after initial FDA clearance. METHODS: Between July 2020 and August 2023, 60 patients received TULSA treatment at our institution in routine clinical service. A subset consented to prospective data collection in the Customized TULSA-PRO Ablation Registry ("CARE", NCT05001477). Patients were treated and followed according to the local standard of care, and data collection included PSA, (clinically-directed) biopsy, additional treatment for PCa, and adverse events. RESULTS: Across all 60 treatments, the median (IQR) procedure time from anesthesia induction to recovery was 3.0 (2.4 – 3.4) hours. Ablation plans were whole-gland (47%), subtotal (33%), and focal (21%), in prostates with median (IQR) volume 39 (30-41) cc (max 83 cc). 39 men were enrolled in CARE, with median (IQR) 12 (3-24) months follow-up (max 36). The median (IQR) age and PSA were 70 (66-76) years and 6.3 (4.8-9.7) ng/ml. All had treatment-naïve organ-confined prostate cancer, with clinical stage T1 (64%), T2a (15%), T2b (5%), or T2c (8%) and ISUP 1 (5%), 2 (69%) or 3 (18%) disease. The PSA nadir was 0.5 (0.1-0.9) ng/ml, a decrease of 92 (85-98)% from baseline. 24 men reached 1-year follow-up. 8 had for-cause biopsy, and overall 1/24 had residual GG2, and 2 had residual GG1 (8% rate of histological failure). One patient received a repeat TULSA due to rising PSA, followed by a negative biopsy. No patient has undergone radical salvage treatment. Three patients incurred a Grade III complication: urethral stenosis and incontinence resolved by artificial sphincter, stenosis resolved with dilation, and bladder neck contracture resolved by transurethral incision. Procedure refinements include optimization of device positioning to ensure all target tissues are within the maximum treatment depth, and restricting the angular extent of repeat exposures to avoid urethral damage. CONCLUSIONS: Our early post-market experience treating GG2-3 prostate cancer with focal through whole-gland ablation plans demonstrates comparable safety and efficacy to that reported in the FDA registration study (NCT02766543), which included lower-grade disease and mandated whole-gland ablation. Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e411 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Ethan Wajswol More articles by this author Ram Pathak More articles by this author Gregory Frey More articles by this author David Sella More articles by this author Chandler Dora More articles by this author Expand All Advertisement PDF downloadLoading ...