Abstract
Rationale: Standardized staging and quantitative reporting is necessary to demonstrate the association of 18F-DCFPyL PET/CT (PSMA) imaging with clinical outcome. This work introduces an automated platform to implement and extend the Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria - aPROMISE. The objective is to validate the performance of aPROMISE in staging and quantifying disease burden in patients with prostate cancer who undergo PSMA Imaging. Methods: This was a retrospective analysis of 109 Veterans with intermediate and high-risk prostate cancer, who underwent PSMA imaging. To validate the performance of aPROMISE, two independent nuclear-medicine physicians conducted aPROMISE-assisted reads, resulting in standardized reports that quantify individual lesions and stage the patients. Patients were staged as having local only disease (miN0M0); regional lymph node only (miN1M0), metastatic disease only (miN0M1), and with both regional and distant metastatic disease (miN1M1). The staging obtained from aPROMISE-assisted reads was compared with the staging by conventional imaging. Cohen’s pairwise kappa agreement was used to evaluate the inter-reader variability. Correlation coefficient and ICC was used to evaluate the inter-reader variability of the quantitative assessment (miPSMA-index) in each stage. Kendall Tau and t-test was used to evaluate the association of miPSMA-index with PSA and Gleason Score. Results: All PSMA images of 109 veterans met the DICOM conformity and the requirements for the aPROMISE analysis. Both independent aPROMISE-assisted analyses demonstrated significant upstaging in patients with localized (23%; N = 20/87) and regional tumor burden (25%; N = 2/8). However, a significant number of patients with bone metastases identified on conventional imaging (NaF PET/CT) were downstaged (29%; N = 4/14). The comparison of the two independent aPROMISE-assisted reads demonstrated a high kappa agreement - 0.82 (miN0M0), 0.90 (miN1M0), and 0.77 (miN0M1). The Spearman correlation of quantitative miPSMA-index was 0.93, 0.96 and 0.97, respectively. As a continuous variable, miPSMA index in the prostate (miT) was associated with risk groups defined by the PSA and Gleason.. Conclusion: Here we demonstrate consistency of the aPROMISE platform between readers and observed substantial upstaging in PSMA imaging compared to the conventional imaging. aPROMISE may contribute to the broader standardization of PSMA imaging assessment and to its clinical utility in management of prostate cancer patients.
- Copyright © 2021 by the Society of Nuclear Medicine and Molecular Imaging, Inc.