Pd39-06 a Randomized Clinical Trial Comparing Focal Ablation and Radical Prostatectomy in Patients With Unilateral Clinically Significant Prostate Cancer. Intention to Treat Analysis at Two-Year Follow-Up

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy II (PD39)1 May 2024PD39-06 A RANDOMIZED CLINICAL TRIAL COMPARING FOCAL ABLATION AND RADICAL PROSTATECTOMY IN PATIENTS WITH UNILATERAL CLINICALLY SIGNIFICANT PROSTATE CANCER. INTENTION TO TREAT ANALYSIS AT TWO-YEAR FOLLOW-UP Eduard Baco, Kristina Flor Galtung, Daniyal Noor, and Erik Rud Eduard BacoEduard Baco , Kristina Flor GaltungKristina Flor Galtung , Daniyal NoorDaniyal Noor , and Erik RudErik Rud View All Author Informationhttps://doi.org/10.1097/01.JU.0001008924.16121.42.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The purpose of this non-inferiority RCT (NCT03668652) is to compare treatment failure at 2 years after focal ablation (FA) and robot-assisted radical prostatectomy (RP) in patients with unilateral clinically significant prostate cancer (PCa). METHODS: Inclusion criteria were unilateral PCa on biopsies (>5mm ISUP 1 or any ISUP 2-3), PSA level of ≤20 ng/ml and age <80 years. The primary outcome is the difference in treatment failure after three years, with a non-inferiority margin set at 15%. The current study reports results after two years, and the results are reported according to the intention to treat (ITT) principles. Bi-parametric MRI with 2-4 targeted and 8-10 systematic trans-perineal biopsies were performed using Koelis -Trinity MRI-TRUS fusion system in all included patients. Patients were then 1:1 randomized into either FA (using transrectal HIFU - Focal One, or transurethral ultrasound ablation - TULSA PRO) or RP performed as a unilateral nerve-sparing surgery. In the FA group, treatment failure was defined as the requirement for secondary RP or radiation therapy due to the presence of high-risk PCa ineligible for repeat FA. In the RP group, treatment failure was defined as a post-treatment PSA >0.2 ng/ml. After treatment, all patients were followed by regular PSA measurements. All patients in FA group underwent MRI and systematic biopsies at one year. In addition, control MRI and prostate biopsy were done during the second post-treatment year in patients with PSA rising beyond the nadir +2 ng/ml. RESULTS: A total of 213 patients were enrolled, 107 were randomized to either FA and 106 to RP. After being randomized to RP, 26 patients (25%) refused RP and required FA. Six other patients declined treatment after randomization. There were no significant differences in mean age (64 vs. 66 years, p=0.3), PSA levels (8.6 vs. 8.5 ng/ml, p=0.9), MRI-measured index tumor diameter (14.5 vs. 15.5 mm, p=0.2), and prostate volume (41.3 vs. 41.7 ml, p=0.9) between FA and RP group at baseline. All included patients were evaluated respecting ITT rules. The proportion of treatment failure was 6.5% (7/107; 95% CI: 3 to 13) in the FA group and 7.5% (8/106, 95% CI: 4 to 14) in the RP group, resulting in a difference of 1% (95% CI: - 6.3 to 8.4). CONCLUSIONS: After a two-year follow-up, the rate of treatment failure in the FA group was found to be non-inferior to that in the RP group. Source of Funding: Oslo University Hospital alone guaranteed this study and all material necessary for diagnostics, treatment and follow-up of patients is owned by Oslo University Hospital © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e815 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Eduard Baco More articles by this author Kristina Flor Galtung More articles by this author Daniyal Noor More articles by this author Erik Rud More articles by this author Expand All Advertisement PDF downloadLoading ...