LBA02-06 PHASE IIB MULTICENTER STUDY ON MRI-GUIDED FOCUSED ULTRASOUND (MRGFUS) FOCAL THERAPY FOR INTERMEDIATE RISK PROSTATE CANCER

Abstract

You have accessJournal of UrologyLate-Breaking Abstracts (LBA2)1 Apr 2020LBA02-06 PHASE IIB MULTICENTER STUDY ON MRI-GUIDED FOCUSED ULTRASOUND (MRGFUS) FOCAL THERAPY FOR INTERMEDIATE RISK PROSTATE CANCER Behfar Ehdaie*, Clare Tempany, Ford Holland, Adam Kibel, Quoc-Dien Trinh, Jeremy Durack, Oguz Akin, Dan Sperling, Jeffrey Wong, Bertram Yuh, David Woodrum, Lance Mynderse, Steven Raman, Allan Pantuck, Marc Schiffman, Timothy McClure, Pejman Ghanouni, and Geoffrey Sonn Behfar Ehdaie*Behfar 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 , 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.0000000000000958.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Introduction: 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 requiring radical therapy while on AS. We investigated whether targeted focal therapy can safely reduce treatment burden for such patients. Methods: Men with unilateral, MRI-visible intermediate risk prostate cancer confirmed on MR-targeted systematic biopsy (PSA =20 ng/mL, GG 2 or 3, stage =T2), no previous treatment for prostate cancer were eligible for this prospective multicenter Phase IIb study (NCT01657942). MRgFUS (Exablate, Insightec) was delivered focally to the GG 2 or 3 lesion, with a margin of normal tissue (=5 mm). The treatment was monitored with real-time MR thermometry. Concurrent GG 1 prostate cancer foci were untreated. Safety (adverse events reported up to 12 months), oncologic outcomes (MRI-targeted systematic prostate biopsy at 6 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 GG 2 and 3 prostate cancer were 78% and 22%, respectively. No serious treatment-related adverse events were reported. Ninety-six men (95%; 95% CI 89%, 98%) had no evidence of GG=2 prostate cancer in the treated area and 79 men (78%; 95% CI 69%, 86%) had no evidence of GG=2 prostate cancer on 6-month MR-targeted systematic biopsy anywhere in the prostate gland. Median overall International Index of Erectile Function-15 (IIEF-15) erectile function scores were slightly lower at 12 months than at baseline (mean score diff of -3.50; 95% CI -5.25, -1.76), as were mean intercourse satisfaction (-1.54; 95% CI -2.46, -0.61), and overall satisfaction (-0.65; 95% CI -1.16, -0.15). Lower urinary tract symptoms, assessed by International Prostate Symptom Score (IPSS), were similar at baseline and at 12-months (difference 0.53; 95%CI -0.22, 1.28), as was IPSS-quality of life score (-0.05; 95% CI -0.25, 0.16). There was non-significant differences in mean Functional Assessment of Cancer Therapy -Prostate (-1.0, 95% CI -3.4, 1.4). Conclusions: MRgFUS focal therapy using real-time MR thermometry has a low rate of genitourinary adverse events and is effective for GG 2 and 3 prostate cancer, based on 6-month biopsy outcomes. This approach may enable men to consider a tissue-preserving approach and defer or avoid radical therapy. Source Of Funding: Insightec, Inc © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1117-e1117 Advertisement Copyright & Permissions© 2020 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 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 PDF downloadLoading ...