Pivotal trial of mri-guided transurethral ultrasound ablation in men with localized prostate cancer: two-year follow-up

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy I (PD17)1 Apr 2020PD17-02 PIVOTAL TRIAL OF MRI-GUIDED TRANSURETHRAL ULTRASOUND ABLATION IN MEN WITH LOCALIZED PROSTATE CANCER: TWO-YEAR FOLLOW-UP Scott Eggener*, Michael Koch, David Penson, Christian Pavlovich, Joseph Chin, Yair Lotan, Steven Raman, Gencay Hatiboglu, Aytekin Oto, James Relle, Jurgen Fütterer, Marc Serrallach, Axel Heidenreich, Masoom Haider, David Bonekamp, Temel Tirkes, Sandeep Arora, Allan Pantuck, Gregory Zagaja, Michiel Sedelaar, Katarzyna Macura, Daniel Costa, Thorsten Persigehl, Andrei Purysko, and Laurence Klotz Scott Eggener*Scott Eggener* More articles by this author , Michael KochMichael Koch More articles by this author , David PensonDavid Penson More articles by this author , Christian PavlovichChristian Pavlovich More articles by this author , Joseph ChinJoseph Chin More articles by this author , Yair LotanYair Lotan More articles by this author , Steven RamanSteven Raman More articles by this author , Gencay HatibogluGencay Hatiboglu More articles by this author , Aytekin OtoAytekin Oto More articles by this author , James RelleJames Relle More articles by this author , Jurgen FüttererJurgen Fütterer More articles by this author , Marc SerrallachMarc Serrallach More articles by this author , Axel HeidenreichAxel Heidenreich More articles by this author , Masoom HaiderMasoom Haider More articles by this author , David BonekampDavid Bonekamp More articles by this author , Temel TirkesTemel Tirkes More articles by this author , Sandeep AroraSandeep Arora More articles by this author , Allan PantuckAllan Pantuck More articles by this author , Gregory ZagajaGregory Zagaja More articles by this author , Michiel SedelaarMichiel Sedelaar More articles by this author , Katarzyna MacuraKatarzyna Macura More articles by this author , Daniel CostaDaniel Costa More articles by this author , Thorsten PersigehlThorsten Persigehl More articles by this author , Andrei PuryskoAndrei Purysko More articles by this author , and Laurence KlotzLaurence Klotz More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000860.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: MRI-guided transurethral ultrasound ablation (TULSA) is a novel minimally-invasive procedure for prostate ablation. We report two-year outcomes from the pivotal TULSA-PRO Ablation Clinical Trial (TACT). METHODS: The study enrolled 115 men with organ-confined prostate cancer (≤T2b, PSA ≤15 ng/ml, Gleason Grade Group 1-2) across 13 centers in USA, Europe, and Canada. Treatment was whole-gland ablation with sparing of the urethra and urinary sphincter. Primary endpoints were safety and PSA reduction at one year. Secondary endpoints included one-year prostate volume reduction, mpMRI, and 10-core biopsy. Two-year outcomes include adverse events, quality of life (IPSS, IIEF, EPIC), and PSA stability. RESULTS: Median (IQR) baseline age was 65 (59-69) years, PSA 6.3 (4.6-7.9) ng/ml, with Grade Group ≥2 (GG2+) disease in 72/115 men (63%). Targeted prostate volumes of 40 (32-50) cc were ablated in 51 (39-66) min, with 98% thermal coverage and ±1.4 mm spatial precision on MRI thermometry. Grade 3 adverse events occurred in 9 (8%) men (all resolved before one year), with no rectal injuries or Grade ≥ 4 events. At one year MRI and biopsy, median prostate volume decreased from 37 to 3 cc, GG2 disease was eliminated in 54/68 (79%) men, and 72/111 (65%) had no evidence of any cancer. Two-year PSA and QoL are currently available for 48/115 patients. Median PSA decreased 95% to a nadir of 0.30 ng/ml, stable from 0.53 ng/ml at one year to 0.68 ng/ml (n=48) at 2 years. Median IPSS was unchanged from 7 to 6 at one year and 5 (n=47) at two years. Moderate urinary incontinence (Grade 2, pads) was reported by 3 patients (2.6%) at one year, with no new incontinence at two years. The rate of moderate erectile dysfunction (Grade 2, responding to PDE5) was 23% at one year, with one new onset at two years. Median change in IIEF-5 recovered from -3 at one year to -1 (n=46) at two years. Erections sufficient for penetration (IIEF Q2 ≥ 2) were maintained by 69/92 (75%) at one year, and for the patient subset with two-year follow-up, by 25/37 (68%) and 23/37 (62%) at one and two years, respectively. Three men whose one-year biopsy indicated incomplete ablation underwent uncomplicated salvage radical prostatectomy. CONCLUSIONS: With two-year follow-up, the TACT pivotal study of MRI-guided transurethral ultrasound ablation (TULSA) in men with localized prostate cancer showed effective disease control in most patients with low toxicity and stable quality of life. Source of Funding: Profound Medical © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e369-e369 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Scott Eggener* More articles by this author Michael Koch More articles by this author David Penson More articles by this author Christian Pavlovich More articles by this author Joseph Chin More articles by this author Yair Lotan More articles by this author Steven Raman More articles by this author Gencay Hatiboglu More articles by this author Aytekin Oto More articles by this author James Relle More articles by this author Jurgen Fütterer More articles by this author Marc Serrallach More articles by this author Axel Heidenreich More articles by this author Masoom Haider More articles by this author David Bonekamp More articles by this author Temel Tirkes More articles by this author Sandeep Arora More articles by this author Allan Pantuck More articles by this author Gregory Zagaja More articles by this author Michiel Sedelaar More articles by this author Katarzyna Macura More articles by this author Daniel Costa More articles by this author Thorsten Persigehl More articles by this author Andrei Purysko More articles by this author Laurence Klotz More articles by this author Expand All Advertisement PDF downloadLoading ...