2026 PHASE 0 TRIAL OF DUPA-99MTC IMAGING IN MEN WITH METASTATIC PROSTATE CANCER

Abstract

You have accessJournal of UrologyImaging/Radiology: Uroradiology (I)1 Apr 20132026 PHASE 0 TRIAL OF DUPA-99MTC IMAGING IN MEN WITH METASTATIC PROSTATE CANCER Thomas Gardner, James Fletcher, Song-chu Ko, Mark Green, Gary Hutchins, Micheal Koch, Mark Tann, Phil Low, and Timothy Ratliff Thomas GardnerThomas Gardner Indianapolis, IN More articles by this author , James FletcherJames Fletcher Indianapolis, IN More articles by this author , Song-chu KoSong-chu Ko Lafayette, IN More articles by this author , Mark GreenMark Green Indianapolis, IN More articles by this author , Gary HutchinsGary Hutchins Indianapolis, IN More articles by this author , Micheal KochMicheal Koch Indianapolis, IN More articles by this author , Mark TannMark Tann Indianapolis, IN More articles by this author , Phil LowPhil Low West Lafayette, IN More articles by this author , and Timothy RatliffTimothy Ratliff West Lafayette, IN More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2445AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Currently, no accurate imaging modality exists for staging metastatic prostate cancer. The Prostascint® scan, using a monoclonal antibody to the intracellular domain of the PSMA molecule, was thought to be an important staging tool, but its limited sensitivity and specificity have discouraged everyday use for patient care. Conjugation of a high affinity PSMA-targeting ligand, 2-[3-(1, 3-dicarboxy propyl)-ureido] pentanedioic acid (DUPA) to technetium 99m (99mTc) has generated a new prostate cancer imaging agent termed DUPA-99mTc. DUPA is a small molecule with high affinity for the same PSMA receptor targeted by Prostascint®, but the small molecule is attached to a chelator that can bind 99mTc, thereby rendering DUPA-99mTc an ideal imaging agent. Using animal models of human prostate cancer, studies demonstrated localization of DUPA-99mTc only to sites of prostate cancer. This Phase 0 trial was designed to confirm these findings in men with advanced prostate cancer. METHODS Nine men with advanced and metastatic prostate cancer confirmed by CT scan and/or bone scan were enrolled in the Phase 0 trial to investigate both the biologic efficacy and toxicity of the DUPA-99mTc agent. Dosimetry studies of images, blood and urine at 5 and 20 mCi doses were obtained at baseline, 5 min, 1, 2, 4, 8 and 24 hours. RESULTS Seven of nine subjects were evaluable. One patient did not receive a full iv dose and another received poorly labeled DUPA-99mTc (70%). The remaining seven patients, who received DUPA-99mTc in excess of 95% labeled product, demonstrated localization to all cancerous areas seen on pre-enrollment images (CT and Bone Scans) plus additional lesions in several of the patients. Two men who had biopsy-confirmed localized recurrent prostate cancer had scans prior to resection, and tissue was monitored intra-operatively and ex-vivo to confirm the higher 99mTc counts in malignant tissues compared to normal tissues. CONCLUSIONS DUPA-99mTc compound can be reliably administered to men with prostate cancer without toxicity and with equal or superior imaging compared to conventional CT and bone scans. A Phase I/II trial will be conducted to confirm the performance of this imaging agent in a larger patient population. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e832 Peer Review Report Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Thomas Gardner Indianapolis, IN More articles by this author James Fletcher Indianapolis, IN More articles by this author Song-chu Ko Lafayette, IN More articles by this author Mark Green Indianapolis, IN More articles by this author Gary Hutchins Indianapolis, IN More articles by this author Micheal Koch Indianapolis, IN More articles by this author Mark Tann Indianapolis, IN More articles by this author Phil Low West Lafayette, IN More articles by this author Timothy Ratliff West Lafayette, IN More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...