@article{f3aa956ea26a49dbb60c9ba3f00c4c33,
title = "Diagnostic performance of 18F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: Results from the CONDOR Phase III, multicenter study",
abstract = "Purpose: Current FDA-approved imaging modalities are inadequate for localizing prostate cancer biochemical recurrence (BCR). 18F-DCFPyL is a highly selective, small-molecule prostate-specific membrane antigen–targeted PET radiotracer. CONDOR was a prospective study designed to determine the performance of 18F-DCFPyL-PET/CT in patients with BCR and uninformative standard imaging. Experimental Design: Men with rising PSA ≥0.2 ng/mL after prostatectomy or ≥2 ng/mL above nadir after radiotherapy were eligible. The primary endpoint was correct localization rate (CLR), defined as positive predictive value with an additional requirement of anatomic lesion colocalization between 18F-DCFPyL-PET/CT and a composite standard of truth (SOT). The SOT consisted of, in descending priority (i) histopathology, (ii) subsequent correlative imaging findings, or (iii) post-radiation PSA response. The trial was considered a success if the lower bound of the 95% confidence interval (CI) for CLR exceeded 20% for two of three 18F-DCFPyL-PET/CT readers. Secondary endpoints included change in intended management and safety. Results: A total of 208 men with a median baseline PSA of 0.8 ng/mL (range: 0.2–98.4 ng/mL) underwent 18F-DCFPyL-PET/ CT. The CLR was 84.8%–87.0% (lower bound of 95% CI: 77.8–80.4). A total of 63.9% of evaluable patients had a change in intended management after 18F-DCFPyL-PET/CT. The disease detection rate was 59% to 66% (at least one lesion detected per patient by 18F-DCFPyL-PET/CT by central readers). Conclusions: Performance of 18F-DCFPyL-PET/CT achieved the study{\textquoteright}s primary endpoint, demonstrating disease localization in the setting of negative standard imaging and providing clinically meaningful and actionable information. These data further support the utility of 18F-DCFPyL-PET/CT to localize disease in men with recurrent prostate cancer.",
author = "{CONDOR Study Group} and Morris, {Michael J.} and Rowe, {Steven P.} and Gorin, {Michael A.} and Lawrence Saperstein and Fr{\'e}d{\'e}ric Pouliot and David Josephson and Wong, {Jeffrey Y.C.} and Pantel, {Austin R.} and Cho, {Steve Y.} and Gage, {Kenneth L.} and Morand Piert and Andrei Iagaru and Pollard, {Janet H.} and Vivien Wong and Jessica Jensen and Tess Lin and Nancy Stambler and Carroll, {Peter R.} and Siegel, {Barry A.}",
note = "Funding Information: We thank the participants who volunteered to take part in this trial, as well as blinded readers, truth panel members, and all members of the trial teams at each participating institution. This study was funded by Progenics Pharmaceuticals, Inc. CONDOR Study Group members are listed in the Supplementary Appendix. Funding Information: M.J. Morris reports personal fees from Progenics prior to the conduct of the study, as well as personal fees from Oric and Curium and nonfinancial support from Endocyte and Fujifilm outside the submitted work. S.P. Rowe reports grants from Progenics Pharmaceuticals during the conduct of the study, as well as personal fees from Precision Molecular, Inc. and grants from FutureChem Co., Ltd. outside the submitted work. M.A. Gorin reports personal fees from BK Medical, KOELIS Inc, Corbin Clinical Resources (Perineologic), and OBS Medical outside the submitted work. CHU de Qubec received funds from Progenics Inc. to cover the direct costs of the study; F. Pouliot has been a consultant for Astellas, Janssen, Sanofi, Bayer, Amgen and Tersera. A.R. Pantel reports grants from Progenics during the conduct of the study, as well as personal fees and nonfinancial support from Blue Earth Diagnostics outside the submitted work. S.Y. Cho reports other from Progenics Pharmaceuticals during the conduct of the study, as well as personal fees from Progenics Pharmaceutical outside the submitted work. K.L. Gage reports grants and nonfinancial support from Progenics Pharmaceuticals during the conduct of the study. M. Piert reports grants from Progenics Pharmaceuticals, Inc. during the conduct of the study. A. Iagaru reports grants and nonfinancial support from Progenics Pharmaceuticals during the conduct of the study, as well as grants from GE Healthcare and Advanced Accelerator Applications and other from ITM outside the submitted work. J.H. Pollard reports other from Johnson & Johnson and personal fees from KEOSYS/Exini outside the submitted work. V. Wong reports other from Progenics Pharmaceuticals during the conduct of the study, as well as other from Progenics Pharmaceuticals outside the submitted work; in addition, V. Wong has a patent for 18F-DCFPyL patent pending and was an employee of Progenics Pharmaceuticals. T. Lin reports other from Progenics outside the submitted work. N. Stambler reports other from Progenics Pharmaceuticals, Inc. during the conduct of the study. P.R. Carroll reports personal fees from Progenics during the conduct of the study, as well as other from Nutcracker Therapeutics and personal fees from Inisightec and Francis Medical outside the submitted work. B.A. Siegel reports grants and personal fees from Progenics Pharmaceuticals during the conduct of the study, as well as grants and personal fees from American College of Radiologyy, Imaginab, Inc., and Blue Earth Diagnostics; personal fees from American Medical Foundation for Peer Review & Education, Avid Radiopharmaceuticals, Inc., Capella Imaging, LLC, Cinven Capital Management (VI) General Partner Limited, Curium Pharma, Radiological Society of North America; and personal fees from Siemens Healthineers outside the submitted work. Additional disclosures submitted by CONDOR Study Group members: A.G. Wibmer reports other from Memorial Sloan Kettering Cancer Center (MSKCC) during the conduct of the study. J.C. Durack reports nonfinancial support and other from Lantheus during the conduct of the study, as well as personal fees from Verix Medical outside the submitted work, and is Past Chair, Society of Interventional Radiology Foundation and Chair, American College of Radiology Interventional Radiology Research Committee. S.B. Solomon reports other from Lantheus during the conduct of the study, as well as grants from GE Healthcare outside the submitted work. P. Sprenkle reports nonfinancial support and other from Progenics during the conduct of the study. T.B. Dorff reports personal fees from Advanced Accelerator Applications outside the submitted work. V. Narayan reports grants and personal fees from Pfizer, Merck, and Janssen; personal fees from Regeneron, Amgen, and Myovant Sciences; and grants from Tmunity Therapeutics outside the submitted work. Z.S. Morris reports personal fees and other from Archeus Technologies and other from Seneca Therapeutics outside the submitted work. A.S. Alva reports grants from Progenics; grants and personal fees from AstraZeneca, Merck, and BMS; personal fees from Pfizer/EMD Serono; and grants from Astellas/Seattle Genetics, Prometheus, Clovis, and Arcus Biosciences outside the submitted work. D. Spratt reports grants and personal fees from Janssen and personal fees from Blue Earth, Boston Scientific, and AstraZeneca outside the submitted work. J.P. Simko reports grants from Progenics during the conduct of the study, as well as grants from Intuitive Surgical outside the submitted work. J.W. Jennings reports grants from Progenics Pharmaceuticals during the conduct of the study. No disclosures were reported by the other authors. Publisher Copyright: {\textcopyright} 2021 American Association for Cancer Research.",
year = "2021",
month = jul,
day = "1",
doi = "10.1158/1078-0432.CCR-20-4573",
language = "English",
volume = "27",
pages = "3674--3682",
journal = "Clinical Cancer Research",
issn = "1078-0432",
number = "13",
}