PD17-01 OUTPATIENT TRANS-RECTAL MR-GUIDED LASER FOCAL THERAPY PHASE II CLINICAL TRIAL: TEN-YEAR INTERIM RESULTS

Abstract

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy I (PD17)1 Apr 2020PD17-01 OUTPATIENT TRANS-RECTAL MR-GUIDED LASER FOCAL THERAPY PHASE II CLINICAL TRIAL: TEN-YEAR INTERIM RESULTS John Feller*, Bernadette Greenwood, Wes Jones, Rob Toth, Steve Gunberg, Jeffrey Herz, and Indian Wells, CA John Feller* John Feller* More articles by this author , Bernadette GreenwoodBernadette Greenwood More articles by this author , Wes JonesWes Jones More articles by this author , Rob TothRob Toth More articles by this author , Steve GunbergSteve Gunberg More articles by this author , Jeffrey HerzJeffrey Herz More articles by this author , and Indian Wells, CAIndian Wells, CA More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000860.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In the United States alone, new prostate cancer cases for 2019 were estimated at 174,650 and deaths at 31,620. Focal therapies for low risk and intermediate risk localized prostate cancer are increasingly being explored. Our objective is to investigate the efficacy of using MR-guided laser focal therapy for MR visible prostate cancer utilizing a trans-rectal approach for laser applicator placement and therapy delivery in an outpatient setting for treatment naive and salvage patients. METHODS: All MR-guided therapy was delivered using a 1.5 Tesla Philips Achieva XR system (Philips Healthcare, Best, The Netherlands) for both image acquisition and real-time thermometry. DynaCAD and DynaLOC (Invivo, Orlando, FL, USA) software were used for image analysis and laser fiber placement planning. Laser focal therapy was delivered using a Visualase (Medtronic, Minneapolis, MN, USA) 15W, 980 nm diode laser applicator introduced trans-rectally using the DynaTRIM (Invivo, Orlando, FL, USA). RESULTS: Under an IRB-approved, HIPAA-compliant protocol, 158 men and 248 cancer foci were treated. No serious adverse events or morbidity were reported. Of the 122 men that underwent 6 mo. biopsy of the treatment site, 32/122 (26%) of men were positive and clinically significant*, while 71/122 (59%) of men were negative. The remaining 18 men (15%) were positive but clinically insignificant. In addition, while most of the positive results were of marginal recurrence, 6 men (5%) had clinically significant incidence cancers. We observed a 37% decrease in mean PSA at 12 months post therapy and no statistically significant change in IPSS and SHIM scores. At ten years, the metastasis free survival rate is 99%, the prostate cancer specific survival rate is 100%, and the overall survival rate is 98%. * Excludes Gleason score 3+3 (Grade Group 1) CONCLUSIONS: Ten year outcomes data indicate that outpatient, trans-rectally delivered MRI-guided laser focal therapy for prostate cancer has similar oncologic control as whole-gland therapy without the associated morbidity. In 94% of the treatment naive patients, whole gland therapy was safely avoided. Focal treatment of prostate cancer may be an attractive option in a subset of men appropriately risk stratified. The precision and safety achieved using laser focal therapy under MRI-guidance may have a favorable impact on cost effectiveness and quality of life without eliminating the possibility of whole-gland treatment. We will continue to follow these men for twenty years as part of an IRB-approved clinical trial (NCT# 02243033)3. Source of Funding: Patient funded research. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e369-e369 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Feller* More articles by this author Bernadette Greenwood More articles by this author Wes Jones More articles by this author Rob Toth More articles by this author Steve Gunberg More articles by this author Jeffrey Herz More articles by this author Indian Wells, CA More articles by this author Expand All Advertisement PDF downloadLoading ...