LBA02-12 A MULTICENTER PHASE 3 STUDY OF PSMA-TARGETED 18 F-DCFPYL PET/CT IN MEN WITH BIOCHEMICALLY RECURRENT PROSTATE CANCER: RESULTS FROM THE CONDOR TRIAL

Abstract

You have accessJournal of UrologyLate-Breaking Abstracts (LBA2)1 Apr 2020LBA02-12 A MULTICENTER PHASE 3 STUDY OF PSMA-TARGETED 18F-DCFPYL PET/CT IN MEN WITH BIOCHEMICALLY RECURRENT PROSTATE CANCER: RESULTS FROM THE CONDOR TRIAL Michael A. Gorin*, Barry A. Siegel, Steven P. Rowe, Lawrence Saperstein, Frédéric Pouliot, David Y. Josephson, Jeffrey Y.C. Wong, Austin R. Pantel, Steve Cho, Kenneth L. Gage, Morand Piert, Andrei Iagaru, Janet H. Pollard, Vivien Wong, Jessica Jensen, Nancy Stambler, Michael J. Morris, and Peter Carroll Michael A. Gorin*Michael A. Gorin* More articles by this author , Barry A. SiegelBarry A. Siegel More articles by this author , Steven P. RoweSteven P. Rowe More articles by this author , Lawrence SapersteinLawrence Saperstein More articles by this author , Frédéric PouliotFrédéric Pouliot More articles by this author , David Y. JosephsonDavid Y. Josephson More articles by this author , Jeffrey Y.C. WongJeffrey Y.C. Wong More articles by this author , Austin R. PantelAustin R. Pantel More articles by this author , Steve ChoSteve Cho More articles by this author , Kenneth L. GageKenneth L. Gage More articles by this author , Morand PiertMorand Piert More articles by this author , Andrei IagaruAndrei Iagaru More articles by this author , Janet H. PollardJanet H. Pollard More articles by this author , Vivien WongVivien Wong More articles by this author , Jessica JensenJessica Jensen More articles by this author , Nancy StamblerNancy Stambler More articles by this author , Michael J. MorrisMichael J. Morris More articles by this author , and Peter CarrollPeter Carroll More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000958.012AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Introduction: Improved diagnostics are needed to better inform the treatment of men with biochemically recurrent (BCR) prostate cancer (PCa). 18F-DCFPyL is a novel PET agent that selectively binds with high affinity to PSMA, a protein overexpressed in PCa cells. We report the performance of PSMA-targeted 18F-DCFPyL PET/CT in the detection of occult sites of disease in men with BCR. Methods: Men with negative or equivocal imaging (e.g., CT, MRI, bone scan, 18F-fluciclovine PET) and a rising PSA after definitive therapy for PCa were eligible. Patients underwent PET/CT imaging 1-2 hours after administration of 9 mCi (333 MBq) of 18F-DCFPyL. The primary endpoint was the correct localization rate (CLR), defined as the percentage of patients with 1:1 correspondence between =1 lesion identified by 18F-DCFPyL PET/CT and the composite standard of truth (SOT) of pathology, correlative imaging, or PSA response. 18F-DCFPyL PET/CT scans were evaluated by three independent, blinded, central imaging readers. SOT results were evaluated by a separate central reader panel or by assessment of PSA response. The a priori definition of trial success was an observed CLR for =2 central readers that exceeds the lower limit of the 95% confidence interval (CI) of 20%. Results: 208 men (median PSA 0.8 [range 0.2-98.4] ng/mL) underwent 18F-DCFPyL PET/CT, which was well tolerated with a single drug-related serious adverse event. Based on central imaging review, PET/CT detected at least one site of disease in 59-66% of patients. The study achieved its primary endpoint with respect to CLR, with the lower limit of the 95% CI for all readers being >77% (Table 1). Conclusions: 18F-DCFPyL PET/CT met the study’s primary endpoint with a CLR of =85% for occult sites of disease in men with BCR and negative or equivocal baseline conventional imaging. The high CLR was independent of SOT method and PSA level, supporting the use of 18F-DCFPyL PET in detecting occult disease which could lead to more informed treatment choices in men with recurrent or suspected metastatic PCa. NCT03739684 Source Of Funding: Progenics Pharmaceuticals, Inc. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1119-e1120 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michael A. Gorin* More articles by this author Barry A. Siegel More articles by this author Steven P. Rowe More articles by this author Lawrence Saperstein More articles by this author Frédéric Pouliot More articles by this author David Y. Josephson More articles by this author Jeffrey Y.C. Wong More articles by this author Austin R. Pantel More articles by this author Steve Cho More articles by this author Kenneth L. Gage More articles by this author Morand Piert More articles by this author Andrei Iagaru More articles by this author Janet H. Pollard More articles by this author Vivien Wong More articles by this author Jessica Jensen More articles by this author Nancy Stambler More articles by this author Michael J. Morris More articles by this author Peter Carroll More articles by this author Expand All Advertisement PDF downloadLoading ...