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

PURPOSE: 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.

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

  1. Memorial Sloan Kettering Cancer Center, New York, NY
  2. The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins, University School of Medicine, Baltimore, MD
  3. The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD
  4. Yale School of Medicine, New Haven, CT
  5. CHU de Quebec and Laval University, Quebec City, QC
  6. Tower Urology, Cedars Sinai Medical Center, Los Angeles, CA
  7. City of Hope, Sierra Madre, CA
  8. Hospital of the University of Pennsylvania, Philadelphia, PA
  9. University of Wisconsin-Madison, Madison, WI
  10. Diagnostic Imaging and Interventional Radiology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
  11. Radiology, University of Michigan, Ann Arbor, MI
  12. Stanford University, Stanford, CA
  13. University of Iowa Hospital, Iowa City, IA
  14. Progenics Pharmaceuticals, Inc., New York, NY
  15. University of California San Francisco, San Francisco, CA
  16. Mallinckrodt Institute of Radiology and Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri
Source: Morris M, Rowe S, Gorin M et al. "Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase 3, Multicenter Study." Clinical Cancer Research. 2021. 1078-0432.CCR-20-4573.

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CONDOR: Study of 18F-DCFPyL PET/CT Imaging in Patients with Suspected Recurrence of Prostate Cancer - Michael J. Morris