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Clinical Trial
. 2021 Jul;206(1):52-61.
doi: 10.1097/JU.0000000000001698. Epub 2021 Feb 26.

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)

Kenneth J Pienta  1 , Michael A Gorin  1   2 , Steven P Rowe  2 , Peter R Carroll  3 , Frédéric Pouliot  4 , Stephan Probst  5 , Lawrence Saperstein  6 , Mark A Preston  7 , Ajjai S Alva  8 , Akash Patnaik  9 , Jeremy C Durack  10 , Nancy Stambler  11 , Tess Lin  11 , Jessica Jensen  11 , Vivien Wong  11 , Barry A Siegel  12 , Michael J Morris  10   13
Affiliations
Clinical Trial

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)

Kenneth J Pienta et al. J Urol. 2021 Jul.

Abstract

Purpose: Prostate 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 methods: Two 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.

Results: A 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.

Conclusions: The 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.

Keywords: molecular imaging; neoplasm metastasis; neoplasm staging; prostatic neoplasms.

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Conflict of interest statement

Financial interest and/or other relationship with Blue Earth, BK Medical, KOELIS, and OBP Medical and Perineologic.

Financial interest and/or other relationship with Insightec Francis Medical Norcal Lynx Group and Nutcracker Therapeutics.

Financial interest and/or other relationship with Astellas, Tersera and Janssen.

Financial interest and/or other relationship with AstraZeneca, Merck, BMS, Celgene, Prometheus, Arcus Biosciences, Pfizer, EMD Serono, Astellas and Seattle Genetics.

Financial interest and/or other relationship with Adient Medical Scientific and Verix Medical.

Financial interest and/or other relationship with Progenics Pharmaceuticals, Inc.

Financial interest and/or other relationship with Avid Radiopharmaceuticals, ImaginAb Inc., Blue Earth Diagnostics LLC, Capella Imaging LLC, Curium Pharma, General Electric Healthcare, Imaginab Inc., American College of Radiology, and American Medical Foundation for Peer Review and Education.

Financial interest and/or other relationship with ORIC Pharmaceuticals and Curium.

Figures

Figure 1.
Figure 1.
Standards for Reporting of Diagnostic Accuracy flow diagram, cohort A (see supplementary Appendix figure for details, https://www.jurology.com). PLN, pelvic lymph node. Pyl, 18F-DCFPyL.
Figure 2.
Figure 2.
Standards for Reporting of Diagnostic Accuracy flow diagram, cohort B.1 Image-guided biopsy as specified by protocol included CT/MRI or ultrasound-guided biopsy.2 While negative for prostate cancer, 18F-DCFPyL (Pyl) scan correctly identified malignancy, and therefore these rare cases were neither considered to be false-positive for prostate cancer nor true-positive for cancer, but rather as nonevaluable.
Figure 3.
Figure 3.
18F-DCFPyL-PET/CT diagnostic performance (median of 3 independent readers) in high-risk prostate cancer in cohort A.
Figure 4.
Figure 4.
18F-DCFPyL-PET/CT up staged patient with high-risk prostate cancer. This cohort A patient was staged at baseline as T1cN0M0; his PSA was 13.68 ng/ml and his biopsy Gleason score was 4+5. CT (not shown) demonstrated no evidence of metastatic disease. Anterior and posterior bone scintigraphy showed changes of left hip arthroplasty and increased tracer uptake in anterior superior iliac spine (arrow) of uncertain significance, butwas otherwise normal. 18F-DCFPyL-PET/CT showed multifocal osseous lesions involving spine, ribs, pelvis and right clavicle. On subsequent biopsy of transverse process of L3, osseous metastatic (M1b) disease was confirmed.
Figure 5.
Figure 5.
Sensitivity and PPV (median of 3 independent readers, relative to histopathology truth standard) of 18F-DCFPyL-PET/CT in metastatic disease sites (A), by anatomical region (B) and across all PSA ranges in men with recurrent or metastatic prostate cancer (C) in cohort B.
See this image and copyright information in PMC

Comment in

  • Editorial Comment.
    Choyke P, Dahut W. Choyke P, et al. J Urol. 2021 Jul;206(1):60-61. doi: 10.1097/JU.0000000000001698.01. Epub 2021 Apr 15. J Urol. 2021. PMID: 33853359 No abstract available.

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