1. A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY).
- Author
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Pienta, Kenneth J, Gorin, Michael A, Rowe, Steven P, Carroll, Peter R, Pouliot, Frédéric, Probst, Stephan, Saperstein, Lawrence, Preston, Mark A, Alva, Ajjai S, Patnaik, Akash, Durack, Jeremy C, Stambler, Nancy, Lin, Tess, Jensen, Jessica, Wong, Vivien, Siegel, Barry A, and Morris, Michael J
- Subjects
Humans ,Prostatic Neoplasms ,Neoplasm Metastasis ,Urea ,Prostate-Specific Antigen ,Lysine ,Prospective Studies ,Reproducibility of Results ,Aged ,Aged ,80 and over ,Middle Aged ,Male ,Positron Emission Tomography Computed Tomography ,molecular imaging ,neoplasm metastasis ,neoplasm staging ,prostatic neoplasms ,Prevention ,Cancer ,Clinical Trials and Supportive Activities ,Urologic Diseases ,Clinical Research ,Aging ,Prostate Cancer ,4.1 Discovery and preclinical testing of markers and technologies ,Detection ,screening and diagnosis ,4.2 Evaluation of markers and technologies ,Clinical Sciences ,Urology & Nephrology - Abstract
PurposeProstate specific membrane antigen-targeted positron emission tomography/computerized tomography has the potential to improve the detection and localization of prostate cancer. OSPREY was a prospective trial designed to determine the diagnostic performance of 18F-DCFPyL-positron emission tomography/computerized tomography for detecting sites of metastatic prostate cancer.Materials and methodsTwo patient populations underwent 18F-DCFPyL-positron emission tomography/computerized tomography. Cohort A enrolled men with high-risk prostate cancer undergoing radical prostatectomy with pelvic lymphadenectomy. Cohort B enrolled patients with suspected recurrent/metastatic prostate cancer on conventional imaging. Three blinded central readers evaluated the 18F-DCFPyL-positron emission tomography/computerized tomography. Diagnostic performance of 18F-DCFPyL-positron emission tomography/computerized tomography was based on imaging results compared to histopathology. In cohort A, detection of pelvic nodal disease (with specificity and sensitivity as co-primary end points) and of extrapelvic metastases were evaluated. In cohort B, sensitivity and positive predictive value for prostate cancer within biopsied lesions were evaluated.ResultsA total of 385 patients were enrolled. In cohort A (252 evaluable patients), 18F-DCFPyL-positron emission tomography/computerized tomography had median specificity of 97.9% (95% CI: 94.5%-99.4%) and median sensitivity of 40.3% (28.1%-52.5%, not meeting prespecified end point) among 3 readers for pelvic nodal involvement; median positive predictive value and negative predictive value were 86.7% (69.7%-95.3%) and 83.2% (78.2%-88.1%), respectively. In cohort B (93 evaluable patients, median prostate specific antigen 11.3 ng/ml), median sensitivity and positive predictive value for extraprostatic lesions were 95.8% (87.8%-99.0%) and 81.9% (73.7%-90.2%), respectively.ConclusionsThe primary end point for specificity was met while the primary end point for sensitivity was not. The high positive predictive value observed in both cohorts indicates that 18F-DCFPyL-positive lesions are likely to represent disease, supporting the potential utility of 18F-DCFPyL-positron emission tomography/computerized tomography to stage men with high-risk prostate cancer for nodal or distant metastases, and reliably detect sites of disease in men with suspected metastatic prostate cancer.
- Published
- 2021