PD17-11 PHASE II CLINICAL TRIAL: SHORT-TERM ONCOLOGIC OUTCOMES OF NANOPARTICLE-DIRECTED FOCAL PHOTOTHERMAL LASER ABLATION

Abstract

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy I (PD17)1 Apr 2020PD17-11 PHASE II CLINICAL TRIAL: SHORT-TERM ONCOLOGIC OUTCOMES OF NANOPARTICLE-DIRECTED FOCAL PHOTOTHERMAL LASER ABLATION Mahir Maruf*, Arvin George, Steven Canfield, Vahara Tamisetti, Ethan Wajswol, Alex Zhu, Matthew S. Davenport, Sara C. Lewis, and Ardeshir R. Rastinehad Mahir Maruf*Mahir Maruf* More articles by this author , Arvin GeorgeArvin George More articles by this author , Steven CanfieldSteven Canfield More articles by this author , Vahara TamisettiVahara Tamisetti More articles by this author , Ethan WajswolEthan Wajswol More articles by this author , Alex ZhuAlex Zhu More articles by this author , Matthew S. DavenportMatthew S. Davenport More articles by this author , Sara C. LewisSara C. Lewis More articles by this author , and Ardeshir R. RastinehadArdeshir R. Rastinehad More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000860.011AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Whole gland treatment of low and intermediate risk prostate cancer (PCa) results in substantial morbidity with variable survival benefit. Focal therapy of PCa may be an alternative that provides cancer control while preserving quality of life. Nanoparticle directed focal photothermal laser ablation (FLA) is a novel ablative modality causing thermal ablation via laser excitation of gold nanoparticles. We aim to report short term oncologic efficacy of nanoparticle FLA. METHODS: In a single-arm multi-center Phase 1/2 clinical trial (NCT02680535), men with organ-confined Gleason Grade group (GGG) ≤ 3 PCa with an MRI visible lesion were prospectively enrolled. Prior to therapy, patients received an intravenous infusion of AuroShellsTM followed by laser excitation under MRI/US fusion guidance. A repeat MRI and fusion biopsy was performed 3 and 12 months post-ablation. The primary outcome of this study was presence of any PCa in the ablation zone at biopsy. Secondary outcome was success defined by the Delphi consensus criteria of any Gleason pattern 4 or GG1 >3mm cancer core length. RESULTS: In total, 45 patients were enrolled. After one patient withdrew, 44 patients (median age 69 years, PSA 8.7ng/ml, gland volume 48.5ml3, and PSA density 0.135 ng/ml2) with 45 lesions underwent nanoparticle directed FLA. At 3 months, 45 biopsies were performed, of which 30 (66.7%) were negative for any PCa. At 3 months, 25/41 patients (61%) had a PSA response >50%. A higher proportion of those with a negative biopsy at 3 months had a PSA response >50% when compared to those with a positive biopsy (64.3% vs 53.8%, p=0.524). Neither age, GGG, pre-treatment PSA, gland volume, or PSA density were associated with biopsy results at 3 months. At 12 months, 25 biopsies were performed of which 18 (72%) were negative for PCa. At 3 months, 35 of 45 (77.8%) lesions met Delphi consensus criteria for success following focal ablation. CONCLUSIONS: Nanoparticle-directed FLA is a feasible and promising ablative modality with acceptable short-term oncologic outcomes. Source of Funding: Philips Healthcare and Nanospectra Biosciences © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e373-e374 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mahir Maruf* More articles by this author Arvin George More articles by this author Steven Canfield More articles by this author Vahara Tamisetti More articles by this author Ethan Wajswol More articles by this author Alex Zhu More articles by this author Matthew S. Davenport More articles by this author Sara C. Lewis More articles by this author Ardeshir R. Rastinehad More articles by this author Expand All Advertisement PDF downloadLoading ...