METHODS: 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.
RESULTS: 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).
CONCLUSION: 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.
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 and Russell K Pachynski
- Memorial Sloan Kettering Cancer Center, New York, NY
- The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins, University School of Medicine, Baltimore, MD
- The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD
- Yale School of Medicine, New Haven, CT
- CHU de Quebec and Laval University, Quebec City, QC
- Tower Urology, Cedars Sinai Medical Center, Los Angeles, CA
- City of Hope, Sierra Madre, CA
- Hospital of the University of Pennsylvania, Philadelphia, PA
- University of Wisconsin-Madison, Madison, WI
- Diagnostic Imaging and Interventional Radiology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
- Radiology, University of Michigan, Ann Arbor, MI
- Stanford University, Stanford, CA
- University of Iowa Hospital, Iowa City, IA
- Progenics Pharmaceuticals, Inc., New York, NY
- University of California San Francisco, San Francisco, CA
- Mallinckrodt Institute of Radiology and Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri
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CONDOR: Study of 18F-DCFPyL PET/CT Imaging in Patients with Suspected Recurrence of Prostate Cancer - Michael J. Morris