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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 : an official journal of the American Association for Cancer Research Morris, M. J., Rowe, S. P., Gorin, M. A., Saperstein, L., Pouliot, F., Josephson, D. Y., Wong, J. Y., Pantel, A. R., Cho, S. Y., Gage, K. L., Piert, M. R., Iagaru, A., Pollard, J. H., Wong, V., Jensen, J., Lin, T., Stambler, N., Carroll, P., Siegel, B. A., Wibmer, A. G., Durack, J. C., Solomon, S. B., Harb, R., Pucar, D., Sprenkle, P., Beauregard, J., Beaulieu, A., Buteau, F., Yamauchi, D., Glaser, S., Dorff, T. B., Narayan, V., Fillare, M. A., Schubert, E., Cooley, G., Morris, Z. S., Langeland, M., Pow-Sang, J. M., Yamoah, K., Alva, A. S., Reichert, Z., Spratt, D., Davidzon, G., Mari Aparici, C., Moradi, F., Tracy, C., Behr, S., Nguyen, H. G., Simko, J. P., Jennings, J. W., Michalski, J. M., Pachynski, R. K. 2021

Abstract

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.

View details for DOI 10.1158/1078-0432.CCR-20-4573

View details for PubMedID 33622706