RANDOMIZED CONTROL TRIAL COMPARING FOCAL PROSTATE ABLATION AND RADICAL PROSTATECTOMY IN PATIENTS WITH INTERMEDIATE RISK PROSTATE CANCER. INITIAL EXPERIENCES

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy (MP78)1 Apr 2019MP78-11 RANDOMIZED CONTROL TRIAL COMPARING FOCAL PROSTATE ABLATION AND RADICAL PROSTATECTOMY IN PATIENTS WITH INTERMEDIATE RISK PROSTATE CANCER. INITIAL EXPERIENCES Eduard Baco*, Ljiljana Vlatkovic, and Erik Rud Eduard Baco*Eduard Baco* More articles by this author , Ljiljana VlatkovicLjiljana Vlatkovic More articles by this author , and Erik RudErik Rud More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000557343.09456.ddAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: The Focal Prostate Ablation versus Radical Prostatectomy (FARP)* is a Norwegian, prospective, parallel group randomized controlled trial that aims to compare focal ablation (FA) of prostate cancer (Pca) using High Intensity Focused Ultrasound (HIFU) versus Radical Prostatectomy (RP) in patients with unilateral, intermediate risk Pca. METHODS: Patient selection: Clinical stage <= T2b, unilateral Pca Gleason score 3+3 and not suitable to active surveillance and/or Gleason score 3+4 or 4+3 and PSA <= 20 ng/ml. Randomization of eligible candidates is performed using a web-based randomization system. Recruitment: 125 subjects per arm; inclusion period is 4 years. FA using HIFU Focal One (EDAP TMS) device is applied to the prostate region where MRI and 3D-TRUS prostate biopsies detected clinically significant Pca. Robot assisted laparoscopic RP or open retro-pubic RP is performed using unilateral nerve sparing technique. The primary objective is to compare the rate or treatment failure in each arm. Treatment failure in FA arm is defined as detection of high-risk cancer in control biopsy requiring RP or External beam radiation treatment (EBRT). Treatment failure in RP arm is defined as post-prostatectomy PSA rising > 0.2 ng/mland need for EBRT. Secondary objective is to compare the impact of treatments on urinary continence, erectile function and quality of life. The follow-up consists of regular PSA measurements and assessments of the functional results. In the FA arm, mpMRI, targeted and systematic biopsies will be performed in all patients at 12 and 36 months after the treatment. RESULTS: To date, 59 patients have been randomized. Mean age: 62.9 yrs (46-73), median PSA: 9 ng/ml (2.2-20) and Gleason Score: 3+3 (5%), 3+4 (73%) and 4+3 (22%). Eleven out of 29 patients (39%) randomized to PR refused RP and demanded FA instead. No patient rejected the FA. (Figure 1). CONCLUSIONS: A randomized controlled trial comparing FA and RP is difficult because of a high rate of cross-overs from RP to FA. These preliminary results emphasize the dimension of the patient s choice in the care of their Pca. *ClinicalTrials.gov Identifier: NCT03668652 Source of Funding: NONE Oslo, Norway© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e1146-e1147 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Eduard Baco* More articles by this author Ljiljana Vlatkovic More articles by this author Erik Rud More articles by this author Expand All Advertisement PDF downloadLoading ...