MP46-11 HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) VS RADICAL PROSTATECTOMY (RP) IN THE CURATIVE TREATMENT OF ISUP 1-2 LOCALIZED PROSTATE CANCER: ONCOLOGICAL INTERMEDIATE RESULTS OF THE HIFI STUDY

Abstract

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy (MP46)1 Sep 2021MP46-11 HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) VS RADICAL PROSTATECTOMY (RP) IN THE CURATIVE TREATMENT OF ISUP 1-2 LOCALIZED PROSTATE CANCER: ONCOLOGICAL INTERMEDIATE RESULTS OF THE HIFI STUDY Pascal Rischmann, Bob Occean, Thierry Chevallier, Xavier Rebillard, Arnaud Villers, Nadine Houede, and Patrick Coloby Pascal RischmannPascal Rischmann More articles by this author , Bob OcceanBob Occean More articles by this author , Thierry ChevallierThierry Chevallier More articles by this author , Xavier RebillardXavier Rebillard More articles by this author , Arnaud VillersArnaud Villers More articles by this author , Nadine HouedeNadine Houede More articles by this author , and Patrick ColobyPatrick Coloby More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002067.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Although HIFU treatment showed promising oncological results in several retrospective studies, large and comparative prospective studies are yet missing. The HiFi study (NCT 04307056) compares HIFU (total or subtotal) vs radical prostatectomy (RP) as a first line treatment in ISUP1 (not eligible for active surveillance) and ISUP2 grade groups localized prostate cancer. The objective of this prospective open-label comparative multicenter study was to evaluate oncological efficacy, functional results and safety. We report here intermediate oncological results at 24-months. METHODS: Inclusion criteria were low or intermediate risk PCa (PSA<15 ng/ml, GS≤3+4 and clinical stage T1-2 NxM0), and a maximum of 4 sextants invaded out of 6, mpMRI. A minimum age of 70 years for HIFU patients (current French guidelines) and a life expectancy of 10 years for the RP patients. HIFU treatment (Focal One®, Edap tms, Vaux-en-Velin) was considered with at least 70% of the gland treated. This study was conducted under IRB and ethic committee approval. Main objective was to compare salvage treatment-free survival (STFS) in both arms. Patients were followed-up for 30-months. RESULTS: From April 2015 to September 2019, 3364 patients (HIFU: 1988, RP: 1376) were prospectively included in 42 French centers. Median age was 74.6 vs 65 years, median PSA was 7.1 vs 6.9 (p=0.4). 59% of the patients were ISUP2 in the HIFU arm vs 63% in the RP arm. At 24-months the STFS was significantly higher in the HIFU arm (97.5%) compared with RP (90.3%) with a risk of experiencing salvage treatment 2.5 times higher after RP (HR: 0.4, 95% CI [0.16-0.34], p<0.01). In the HIFU arm, the positive biopsy rate was 8.6%; in the RP arm, positive margins were 24.7%. CONCLUSIONS: These intermediate results do not yet allow a fair comparison of the two arms due to the specific profile of each group. Indeed, following early positive margin results in RP arm, salvage radiotherapy is probably initiated earlier. The follow-up of oncological data up to 30 months, scheduled in the study, is justified. Source of Funding: Sponsor: French Urological AssociationFunding: Innovation Package (French Ministry of Health) © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e817-e817 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Pascal Rischmann More articles by this author Bob Occean More articles by this author Thierry Chevallier More articles by this author Xavier Rebillard More articles by this author Arnaud Villers More articles by this author Nadine Houede More articles by this author Patrick Coloby More articles by this author Expand All Advertisement Loading ...