Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase 3, Multicenter Study.

Current FDA-approved imaging modalities are inadequate for localizing prostate cancer biochemical recurrence (BCR). 18F-DCFPyL is a highly selective, small-molecule PSMA-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.

Men with rising PSA {greater than or equal to}0.2 ng/mL after prostatectomy or {greater than or equal to}2 ng/mL above nadir after radiation therapy were eligible. The primary endpoint was correct localization rate (CLR) defined as positive predictive value with an additional requirement of anatomic lesion co-localization between 18F-DCFPyL-PET/CT and a composite standard of truth (SOT). The SOT consisted of, in descending priority: 1) histopathology, 2) subsequent correlative imaging findings, or 3) post-radiation PSA response. The trial was considered a success if the lower bound of the 95% confidence interval for CLR exceeded 20% for 2 of 3 18F‑DCFPyL-PET/CT readers. Secondary endpoints included change in intended management and safety.

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%). 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).

Performance of 18F-DCFPyL-PET/CT achieved the study'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.

Clinical cancer research : an official journal of the American Association for Cancer Research. 2021 Feb 23 [Epub ahead of print]

Michael J Morris, Steven P Rowe, Michael A Gorin, Lawrence Saperstein, Frédéric Pouliot, David Y Josephson, Jeffrey Yc Wong, Austin R Pantel, Steve Y Cho, Kenneth L Gage, Morand R Piert, Andrei Iagaru, Janet H Pollard, Vivien Wong, Jessica Jensen, Tess Lin, Nancy Stambler, Peter Carroll, Barry A Siegel, Andreas G Wibmer, Jeremy C Durack, Stephen B Solomon, Rana Harb, Darko Pucar, Preston Sprenkle, Jean-Mathieu Beauregard, Alexis Beaulieu, Francois-Alexandre Buteau, Dave Yamauchi, Scott Glaser, Tanya B Dorff, Vivek Narayan, Matthew A Fillare, Erin Schubert, Greg Cooley, Zachary S Morris, Monica Langeland, Julio M Pow-Sang, Kosj Yamoah, Ajjai S Alva, Zachery Reichert, Daniel Spratt, Guido Davidzon, Carina Mari Aparici, Farshad Moradi, Chad Tracy, Spencer Behr, Hao G Nguyen, Jeffry P Simko, Jack W Jennings, Jeff M Michalski, Russell K Pachynski

Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College ., Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine., Johns Hopkins University School of Medicine., Yale School of Medicine., Surgery, CHU de Quebec and Laval University., Tower Urology, Cedars-Sinai Medical Center., Department of Radiation Oncology, City of Hope Cancer Center., Radiology, University of Pennsylvania., Radiology, University of Wisconsin–Madison., Diagnostic Imaging and Interventional Radiology, Moffitt Cancer Center., Department of Radiology, University of Michigan–Ann Arbor., Radiology, Nuclear Medicine, Stanford University Medical Center., University of Iowa Hospital., Progenics Pharmaceuticals, Inc., Clinical Development, Progenics Pharmaceuticals, Inc., Urology, University of California, San Francisco., Mallinckrodt Institute of Radiology, Siteman Cancer Center, Washington University., Radiology, Memorial Sloan Kettering Cancer Center., Interventional Radiology, Memorial Sloan Kettering Cancer Center., Department of Radiology & Biomedical Imaging, Yale University., Yale University., CHU de Quebec and Laval University., Diagnostic Radiology, City of Hope Cancer Center., Radiation Oncology, City Of Hope National Medical Center., Department of Medical Oncology and Therapeutics research, City Of Hope National Medical Center., Hematology/Oncology, University of Pennsylvania., Radiology & Nuclear Medicine, University of Pennsylvania., University of Pennsylvania., Human Oncology, University of Wisconsin–Madison., University of Wisconsin–Madison., Genitourinary Oncology, Moffitt Cancer Center., Cancer Epidemiology and Radiation Oncology, H Lee Moffitt Cancer Center & Research Institute., Internal Medicine, Division of Hematology/Oncology, University of Michigan–Ann Arbor., Internal Medicine, University of Michigan–Ann Arbor., University of Michigan–Ann Arbor., Radiology/Nuclear Medicine, Stanford University Medical Center., Divisions of Nuclear Medicine and Molecular Imaging, Stanford University School of Medicine., Stanford University Medical Center., Radiology, University of California, San Francisco., Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco., Washington University in St. Louis School of Medicine., Division of Oncology, Washington University in St. Louis School of Medicine.

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