PD61-04 PRELIMINARY PHASE 1 SAFETY AND EFFICACY RESULTS OF A PROSTATE SPECIFIC MEMBRANE ANTIGEN (PSMA) TARGETING FLUOROPHORE IN PATIENTS UNDERGOING ROBOTIC PROSTATECTOMY

Abstract

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy V (PD61)1 Sep 2021PD61-04 PRELIMINARY PHASE 1 SAFETY AND EFFICACY RESULTS OF A PROSTATE SPECIFIC MEMBRANE ANTIGEN (PSMA) TARGETING FLUOROPHORE IN PATIENTS UNDERGOING ROBOTIC PROSTATECTOMY Hao Nguyen, Alexander Antaris, Nynke Van den Berg, Lingru Xue, Scott Greenberg, Anna Muchnik, Alwin Klaassen, Jeff Simko, Sanjeev Dutta, Jonathan Sorger, and Peter Carroll Hao NguyenHao Nguyen More articles by this author , Alexander AntarisAlexander Antaris More articles by this author , Nynke Van den BergNynke Van den Berg More articles by this author , Lingru XueLingru Xue More articles by this author , Scott GreenbergScott Greenberg More articles by this author , Anna MuchnikAnna Muchnik More articles by this author , Alwin KlaassenAlwin Klaassen More articles by this author , Jeff SimkoJeff Simko More articles by this author , Sanjeev DuttaSanjeev Dutta More articles by this author , Jonathan SorgerJonathan Sorger More articles by this author , and Peter CarrollPeter Carroll More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002098.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Recurrence rates following surgery for high–risk prostate cancer remain unchanged due, in large part, to the failure to completely excise locally extensive and/or regional disease. This stems from a fundamental inability to differentiate cancer from healthy tissue. IS-002 is a novel near-infrared PSMA targeted fluorophore that is designed to enhance intraoperative cancer visualization during robotic prostatectomy for compete tumor removal. We hypothesize that IS-002 fluorescence-guided surgery (FGS) may improve oncological outcomes by assisting in cancer detection and thus enabling complete cancer excision. Objective: Evaluation of IS-002 safety, pharmacokinetics, and efficacy in a Phase I dose-escalation study (n=24) in patients undergoing robotic prostatectomy using the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA) equipped with Sensitive FireflyTM 800 nm near-infrared imaging capability (SF). METHODS: Patients with high-risk prostate cancer (CAPRA 6-10) received IS-002 intravenously 24 hr. prior to surgery. Six subjects per cohort were dosed at 50, 100, 150 or 200 µg/kg. Safety (adverse events, labs, UA, and ECG) was assessed during a 14-day period. Intraoperative and ex-vivo imaging results were confirmed using histopathology for ground truth cancer determination. RESULTS: IS-002 was studied in 9 subjects (24 planned) with adverse events limited to expected green urine and feces and no major adverse events. Among the 7 patients with complete histopathology data, IS-002 successfully achieved pathologically confirmed tumor fluorescence in 7/7 (100%). Ex vivo tumor-to-background ratio quantification spanned 38.8 – 220.6 in the 50 µg/kg dose cohort. Surgeons using SF + IS-002 reported excellent tumor discrimination over background (Figure 1), and fluorescence outperformed standard imaging (MRI,CT,TRUS, white light endoscopy) at revealing bladder neck invasion (2/2), seminal vesical invasion (2/2), neurovascular bundle involvement (2/2), and lymph node involvement (3/3). CONCLUSIONS: IS-002 is safe and well tolerated for FGS at evaluated doses for intraoperative tumor detection beyond the prostate and margin assessment during robotic prostatectomy. Source of Funding: Intuitive Surgical Inc. and Goldberg-Benioff Program in Translational Cancer Biology © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1067-e1068 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hao Nguyen More articles by this author Alexander Antaris More articles by this author Nynke Van den Berg More articles by this author Lingru Xue More articles by this author Scott Greenberg More articles by this author Anna Muchnik More articles by this author Alwin Klaassen More articles by this author Jeff Simko More articles by this author Sanjeev Dutta More articles by this author Jonathan Sorger More articles by this author Peter Carroll More articles by this author Expand All Advertisement Loading ...