P2-06 Hifi Trial: Hifu vs Radical Prostatectomy for Localized Prostate Cancer in 3328 Cases. Final Results

You have accessJournal of UrologyParadigm-shifting, Practice-changing Clinical Trials in Urology (P2)1 May 2024P2-06 HIFI TRIAL: HIFU VS RADICAL PROSTATECTOMY FOR LOCALIZED PROSTATE CANCER IN 3328 CASES. FINAL RESULTS Pascal J. Rischmann, Patrick Coloby, Thierry Chevallier, Nadine Houede, Arnauld Villers, and Guillaume Ploussard Pascal J. RischmannPascal J. Rischmann , Patrick ColobyPatrick Coloby , Thierry ChevallierThierry Chevallier , Nadine HouedeNadine Houede , Arnauld VillersArnauld Villers , and Guillaume PloussardGuillaume Ploussard View All Author Informationhttps://doi.org/10.1097/01.JU.0001015816.87470.c9.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: High-intensity focused ultrasound (HIFU) has emerged as an interesting ablative alternative to standard treatments such as radical prostatectomy (RP) or radiation therapy (RT) for localized prostate cancer (PCa). However no prospective comparative data has been published. METHODS: HIFI trial (NCT 04307056) is a non-inferiority, prospective, non-randomized, nationwide study performed in 46 French centers comparing HIFU vs RP. Inclusion criteria were age > 69 years in the HIFU arm (2014 French guidelines), low and intermediate risk PCa (cT1-2 NxM0, GG 1 or 2, PSA 3mm and/or pT3b. All decisions were validated by a local tumor board and reviewed by the national scientific board of the study. Secondary endpoints were metastasis, specific and overall survival (OS), safety and functional outcomes. Patients were followed for at least 30 months. RESULTS: From April 2015 to September 2019, 3328 patients were included (1967 consecutive HIFU and 1361 RP). Median PSA was 7.1 vs 6.9 (p=0.54), GG2 were 50% (p=0.25), in HIFU and RP arms respectively. 1859 patients had 1 HIFU session (94.7%) while 108 had 2 sessions (5.5%). Median follow up for censored patients was 30 months in both treatment groups. The 30-month STFS rate was significantly higher in the HIFU arm (89.8%) compared with the RP arm (86.2%; HR 0.76; 95%CI 0.61-0.96, p=0.008). This result was confirmed by using a pre-planned propensity score matching, including age and other covariates (BMI, ASA score, Prostate volume, PSA level, Grade Group, and ICS score at baseline) and an adjusted analysis using the same covariates in a regression Cox model for survival analysis (HR 0.71; 95% CI 0.52-0.97, p=0.03) (Fig 1). There was no influence of age on salvage treatment decision. No distant metastasis or PCa-specific death was reported. When adjusted on age, there was no OS difference between groups (HR=2.53; 95% CI 0.95-6.73, p=0.06). Complications >IIIa were reported in 2.7% and 2.1% of patients after HIFU and RP, respectively (p=0.26). At 12 months, urinary continence (UPS score ≤1) was better in the HIFU group (RR=0.76; 95%CI 0.70 -0.83 p<0.001). IIEF-5 score decreased significantly less after HIFU than after RP (median Δ = - 4 vs - 9 , p<0.001). There was no statistical difference in quality of life (EORTC QLQC-30) despite an age difference of 9.6 years between the two arms. CONCLUSIONS: The HIFI trial is the first prospective study comparing HIFU vs RP as primary treatment for localized prostate cancer. Salvage therapy-free survival after HIFU was not inferior to that reported after RP at the pre- planned 30-month follow-up. Patient-reported outcomes showed a significant lower negative impact of HIFU on functional outcomes such as urinary continence and erectile function. Promoter: Association Française d'Urologie Download PPT Source of Funding: French Ministry of Health © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5S2May 2024Page: e4 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Pascal J. Rischmann More articles by this author Patrick Coloby More articles by this author Thierry Chevallier More articles by this author Nadine Houede More articles by this author Arnauld Villers More articles by this author Guillaume Ploussard More articles by this author Expand All Advertisement PDF downloadLoading ...