MP13-06 MULTICENTER CLINICAL TRIAL OF REAL-TIME PROSTATE CANCER DIAGNOSIS USING OPTICAL SPECTROSCOPY GUIDED PROSTATE BIOPSY (2019)

You have accessJournal of UrologyProstate Cancer: Detection & Screening I (MP13)1 Apr 2019MP13-06 MULTICENTER CLINICAL TRIAL OF REAL-TIME PROSTATE CANCER DIAGNOSIS USING OPTICAL SPECTROSCOPY GUIDED PROSTATE BIOPSY James Wysock*, Neal Shore, Michael Gorin, Alan Partin, Behfar Ehdaie, James Eastham, Lawrence Karsh, Kirk Wojno, Christopher Pieczonka, Matthew Leavitt, Paul Arangua, and E. David Crawford James Wysock*James Wysock* More articles by this author , Neal ShoreNeal Shore More articles by this author , Michael GorinMichael Gorin More articles by this author , Alan PartinAlan Partin More articles by this author , Behfar EhdaieBehfar Ehdaie More articles by this author , James EasthamJames Eastham More articles by this author , Lawrence KarshLawrence Karsh More articles by this author , Kirk WojnoKirk Wojno More articles by this author , Christopher PieczonkaChristopher Pieczonka More articles by this author , Matthew LeavittMatthew Leavitt More articles by this author , Paul AranguaPaul Arangua More articles by this author , and E. David CrawfordE. David Crawford More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555219.05345.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Greater than 90% of TRUS-guided prostate biopsy cores are histopathologically classified as benign. Optical spectroscopy allows characterization of tumors by measurement of spectral tissue properties. As tissue undergoes malignant growth, the optical properties change. Assessment of changes in tissue optical properties may permit the diagnosis of prostate cancer (PCa) at the time of biopsy. The objective of this study was to acquire and analyze spectral data and correlative tissue biopsy cores using the ClariCore Optical Biopsy System (COBS) for training and development of a prostate tissue classification algorithm. METHODS: COBS is comprised of a 16-gauge core biopsy needle with an integrated optical sensor and a console which provides real-time prostate tissue classification information prior to tissue collection. Auto advancing of the inner needle via a built-in motor allows tissue classification along the length of the core in 1 mm increments. Men, scheduled for TRUS-guided biopsy with a prostate volume > 20cc were included in this multicenter study. Using COBS, 10-12 tissue biopsy cores were targeted from each patient. Fluorescence spectra at 280 and 340 nm excitations and elastic scattering spectra between 400-750 nm were collected for every core in 1 mm steps. For each tissue core, 1 mm segments were histopathologically classified either as benign or malignant and correlated with respective spectra measurements. RESULTS: Of the 144 patients included in the intent to treat analysis, 142 (98.6%) had biopsy cores successfully collected with the COBS. In total, 1,158 biopsy cores collected with the COBS were used for algorithm development. Of these cores, 185 (16.0%) were found to contain PCa. The COBS algorithm results are provided in Table 1. During the course of the study no serious adverse events were reported. CONCLUSIONS: This study demonstrated that COBS can successfully acquire spectral data and correlative tissue biopsy cores for algorithm development. High sensitivity and negative predictive value can be used for precise targeting of PCa lesions with subsequent improvement in the diagnostic yield of TRUS-guided prostate biopsies. The COBS procedure was safe and well-tolerated by patients. Additional studies are underway to further establish accuracy and clinical utility. Source of Funding: Precision Biopsy Inc., Aurora, CO New York, NY; Myrtle Beach, SC; Baltimore, MD; New York, NY; Denver, CO; Royal Oak, MI; Syracuse, NY; Provo, UT; Aurora, CO© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e179-e179 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information James Wysock* More articles by this author Neal Shore More articles by this author Michael Gorin More articles by this author Alan Partin More articles by this author Behfar Ehdaie More articles by this author James Eastham More articles by this author Lawrence Karsh More articles by this author Kirk Wojno More articles by this author Christopher Pieczonka More articles by this author Matthew Leavitt More articles by this author Paul Arangua More articles by this author E. David Crawford More articles by this author Expand All Advertisement PDF downloadLoading ...