MP78-11 RANDOMIZED CONTROL TRIAL COMPARING FOCAL PROSTATE ABLATION AND RADICAL PROSTATECTOMY IN PATIENTS WITH INTERMEDIATE RISK PROSTATE CANCER. INITIAL EXPERIENCES

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 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. (Figure1). 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.