Mp73-05 pivotal study of mri-guided transurethral ultrasound ablation (tulsa) of localized prostate cancer: 4-year follow up

You have accessJournal of UrologyCME1 Apr 2023MP73-05 PIVOTAL STUDY OF MRI-GUIDED TRANSURETHRAL ULTRASOUND ABLATION (TULSA) OF LOCALIZED PROSTATE CANCER: 4-YEAR FOLLOW UP Christian Pavlovich, Scott Eggener, Michael Koch, David Penson, James Relle, Steven Raman, Yair Lotan, Jurgen Futterer, Gencay Hatiboglu, Marc Serrallach, Axel Heidenreich, Aytekin Oto, Masoom Haider, J.P. Michiel Sedelaar, Temel Tirkes, Sandeep Arora, Katarzyna Macura, Daniel Costa, Allan Pantuck, Joyce Bomers, David Bonekamp, Thorsten Persigehl, Gina Clarke, Robert Staruch, Joseph Chin, and Laurence Klotz Christian PavlovichChristian Pavlovich More articles by this author , Scott EggenerScott Eggener More articles by this author , Michael KochMichael Koch More articles by this author , David PensonDavid Penson More articles by this author , James RelleJames Relle More articles by this author , Steven RamanSteven Raman More articles by this author , Yair LotanYair Lotan More articles by this author , Jurgen FuttererJurgen Futterer More articles by this author , Gencay HatibogluGencay Hatiboglu More articles by this author , Marc SerrallachMarc Serrallach More articles by this author , Axel HeidenreichAxel Heidenreich More articles by this author , Aytekin OtoAytekin Oto More articles by this author , Masoom HaiderMasoom Haider More articles by this author , J.P. Michiel SedelaarJ.P. Michiel Sedelaar More articles by this author , Temel TirkesTemel Tirkes More articles by this author , Sandeep AroraSandeep Arora More articles by this author , Katarzyna MacuraKatarzyna Macura More articles by this author , Daniel CostaDaniel Costa More articles by this author , Allan PantuckAllan Pantuck More articles by this author , Joyce BomersJoyce Bomers More articles by this author , David BonekampDavid Bonekamp More articles by this author , Thorsten PersigehlThorsten Persigehl More articles by this author , Gina ClarkeGina Clarke More articles by this author , Robert StaruchRobert Staruch More articles by this author , Joseph ChinJoseph Chin More articles by this author , and Laurence KlotzLaurence Klotz More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003341.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) of the prostate is an in-bore procedure that thermally coagulates tissue under real-time closed-loop MRI thermometry control, allowing precise adjustment of treatment parameters to match tissue effects. We report 4-year outcomes from the TACT pivotal trial of TULSA in men with low- to intermediate-risk prostate cancer (PCa) (NCT02766543). METHODS: Across 13 sites in 5 countries, 115 men with organ-confined PCa underwent a single whole-gland TULSA treatment sparing the prostatic urethra and urinary sphincter. Eligibility criteria included stage≤T2b, PSA≤15 ng/mL, and Grade Group (GG)1-2. One-year endpoints included adverse events, quality-of-life (QOL), PSA reduction, histologic control on 10-core biopsy, and prostate volume reduction on mpMRI. Patients are being followed to five years for adverse events, QOL, PSA, and the rate of salvage treatment. RESULTS: Median (IQR) age and PSA at baseline were 65 (59-69) and 6.3 (4.6-7.9) ng/mL, with Grade Group (GG) ≥2 disease in 72/115 men (63%; 60% GG2; 3% GG3 included with protocol deviation). Median (IQR) ablation time was 51 (39-66) min. Median prostate volume decreased from 37.3 to 2.8 cc (92%). At the 1-year biopsy, 94/111 (85%) were free of ≥GG2 disease, 88/111 (79%) were free of GG2 or high-volume GG1 disease, 16/111 (14%) had low-volume GG1. By 4 years 18 men (16%) received salvage treatment (8 radical prostatectomy, 8 radiation therapy, 1 androgen deprivation therapy, 1 surgery plus radiation) without unexpected complications. At 4 years, median (IQR) PSA was 0.9 (0.4-1.6) ng/mL, a reduction of 86% (75%-95%) from baseline and of 96% to the nadir (n=76). Median IPSS decreased from 7 at baseline to 5 at 4 years (n=73). Erections sufficient for penetration (IIEFQ2≥2) were recovered by 69/92 (75%) at 1 year, and 46/57 (81%) at 4 years. Pad-free urinary continence was preserved at 1 and 4 years in 102/111 (92%) and 68/72 (94%), and social continence was preserved in 110/111 (99%) and 71/72 (99%) men. There was no rectal injury or Grade≥4 adverse event. Grade 3 adverse events occurred in 9 men (8%), including GU infection, retention, pain, urinoma, and stricture; all were resolved before 1 year. CONCLUSIONS: Effective disease control is durable to 4 years, with continued recovery of quality of life and a favorable safety profile after whole-gland ablation with TULSA. Source of Funding: Profound Medical © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1036 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Christian Pavlovich More articles by this author Scott Eggener More articles by this author Michael Koch More articles by this author David Penson More articles by this author James Relle More articles by this author Steven Raman More articles by this author Yair Lotan More articles by this author Jurgen Futterer More articles by this author Gencay Hatiboglu More articles by this author Marc Serrallach More articles by this author Axel Heidenreich More articles by this author Aytekin Oto More articles by this author Masoom Haider More articles by this author J.P. Michiel Sedelaar More articles by this author Temel Tirkes More articles by this author Sandeep Arora More articles by this author Katarzyna Macura More articles by this author Daniel Costa More articles by this author Allan Pantuck More articles by this author Joyce Bomers More articles by this author David Bonekamp More articles by this author Thorsten Persigehl More articles by this author Gina Clarke More articles by this author Robert Staruch More articles by this author Joseph Chin More articles by this author Laurence Klotz More articles by this author Expand All Advertisement PDF downloadLoading ...