LBA02-12 MRI-GUIDED FOCUSED ULTRASOUND (MRgFUS) FOCAL THERAPY FOR INTERMEDIATE-RISK PROSTATE CANCER: FINAL RESULTS OF A PHASE IIB MULTICENTER STUDY

Abstract

You have accessJournal of UrologyLate-breaking Abstract II - Malignant1 Sep 2021LBA02-12 MRI-GUIDED FOCUSED ULTRASOUND (MRgFUS) FOCAL THERAPY FOR INTERMEDIATE-RISK PROSTATE CANCER: FINAL RESULTS OF A PHASE IIB MULTICENTER STUDY Behfar Ehdaie, Clare Tempany, Ford Holland, Adam Kibel, Quoc-Dien Trinh, Jeremy Durack, Oguz Akin, Andrew Vickers, Dan Sperling, Jeffrey Wong, Bertram Yuh, David Woodrum, Lance Mynderse, Steven Raman, Allan Pantuck, Marc Schiffman, Timothy McClure, Pejman Ghanouni, and Geoffrey Sonn Behfar EhdaieBehfar Ehdaie More articles by this author , Clare TempanyClare Tempany More articles by this author , Ford HollandFord Holland More articles by this author , Adam KibelAdam Kibel More articles by this author , Quoc-Dien TrinhQuoc-Dien Trinh More articles by this author , Jeremy DurackJeremy Durack More articles by this author , Oguz AkinOguz Akin More articles by this author , Andrew VickersAndrew Vickers More articles by this author , Dan SperlingDan Sperling More articles by this author , Jeffrey WongJeffrey Wong More articles by this author , Bertram YuhBertram Yuh More articles by this author , David WoodrumDavid Woodrum More articles by this author , Lance MynderseLance Mynderse More articles by this author , Steven RamanSteven Raman More articles by this author , Allan PantuckAllan Pantuck More articles by this author , Marc SchiffmanMarc Schiffman More articles by this author , Timothy McClureTimothy McClure More articles by this author , Pejman GhanouniPejman Ghanouni More articles by this author , and Geoffrey SonnGeoffrey Sonn More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002149.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Radical whole-gland therapy for prostate cancer can lead to significant side-effects. Patients with Grade Group (GG) 2 or 3 prostate cancer are often ineligible for active surveillance (AS) or experience early disease progression on AS requiring radical therapy. We investigated whether focal therapy can produce durable oncologic outcomes and preserve urinary and sexual function. METHODS: Men with MRI-visible intermediate risk prostate cancer (PSA ≤20 ng/mL, GG2 or 3, stage ≤T2) and no prior cancer-directed treatment were eligible for this multicenter Phase IIb study (NCT01657942). Focal MRgFUS was delivered to the index lesion, with the targeted region contoured to include the MRI-visible lesion and up to 10 mm margin of normal appearing tissue. Concurrent GG1 prostate cancer foci were untreated. Safety (adverse events reported up to 24-months), oncologic outcomes (MRI-targeted systematic prostate biopsy at 6-and 24-months in all men), and genitourinary functional outcomes were assessed. RESULTS: 101 men were treated from May 4, 2017 to December 21, 2018 at 8 healthcare centers. Median age and PSA were 63 years and 5.7 ng/mL, respectively. Percentage of men treated with GG2 and 3 prostate cancer were 78% and 22%, respectively. No serious treatment-related adverse events were reported at 24-months. Ninety-six men (95%) had no evidence of GG ≥2 prostate cancer in the treated area at 6 months and 74 men (84%) had no evidence of GG ≥2 prostate cancer in the treated area at 24 months. International Index of Erectile Function-15 (IIEF-15) erectile function scores and lower urinary tract symptoms, assessed by International Prostate Symptom Score (IPSS), were similar at baseline and 24-months (Table 1). No patients reported stress urinary incontinence requiring pad-use at 24-months. CONCLUSIONS: MRgFUS focal therapy using real-time MR thermometry has favorable quality of life outcomes compared to radical prostatectomy and demonstrates durable oncologic outcomes for men with GG 2 and GG 3 prostate cancer based on 6- and 24-month biopsy. These data support a randomized controlled trial in men with intermediate risk prostate cancer seeking to avoid radical whole-gland treatment. Source of Funding: Insightec, Inc © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1180-e1180 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Behfar Ehdaie More articles by this author Clare Tempany More articles by this author Ford Holland More articles by this author Adam Kibel More articles by this author Quoc-Dien Trinh More articles by this author Jeremy Durack More articles by this author Oguz Akin More articles by this author Andrew Vickers More articles by this author Dan Sperling More articles by this author Jeffrey Wong More articles by this author Bertram Yuh More articles by this author David Woodrum More articles by this author Lance Mynderse More articles by this author Steven Raman More articles by this author Allan Pantuck More articles by this author Marc Schiffman More articles by this author Timothy McClure More articles by this author Pejman Ghanouni More articles by this author Geoffrey Sonn More articles by this author Expand All Advertisement Loading ...