Lead Investigator: Timothy Perk, AIQ Solutions
Title of Proposal Research: External validation of the AIQ predictive score of clinical benefit using Sodium Fluoride (NaF) position emission tomography/computed tomography (PET/CT) images in metastatic prostate cancer (mPC).
Vivli Data Request: 7144
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Between 2003 and 2017, the percentage of patients diagnosed with metastatic prostate cancer increased from 4% to 8%. This increase occurred even though the overall age-adjusted incidence of prostate cancer in the United States went down from 155 per 100,000 in 2003, to 105 per 100,000 in 2017.
AIQ has developed a predictive score that can predict progression free survival of metastatic prostate cancer (mPC) patients using Sodium Fluoride (NaF) position emission tomography/computed tomography (PET/CT) imaging. We hope to use this data as one of three external validation sets to prove that the score is generalizable. If the score is shown to be both predictive and generalizable, we hope to include it in future clinical studies as a way to provide early go no-go decisions.
Statistical Analysis Plan:
AIQ wishes to use this study because our technology has already been applied to this dataset as part of a publication and we wish to use the data for further analyses: Kyriakopoulos, C. E., Heath, E. I., Ferrari, A., Sperger, J. M., Singh, A., Perlman, S. B., Roth, A. R., Perk, T. G., Modelska, K., Porcari, A., Duggan, W., Lang, J. M., Jeraj, R., & Liu, G. (2020). Exploring Spatial-Temporal Changes in 18 F-Sodium Fluoride PET/CT and Circulating Tumor Cells in Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide. J Clin Oncol, JCO2000348. https://doi.org/10.1200/JCO.20.00348
Baseline and 3 month metastatic prostate cancer (mPC) patients using Sodium Fluoride (NaF) position emission tomography/computed tomography (PET/CT) images analyzed using AIQ technology will be used to extract the necessary imaging metrics to generate our score. The score will be compared to duration of clinical benefit.
A PHASE 2, OPEN-LABEL, SINGLE-ARM STUDY OF 18F-SODIUM FLUORIDE PET/CT BONE IMAGING IN ENZALUTAMIDE-TREATED CHEMOTHERAPY-NAÏVE PATIENTS WITH BONE-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Data Contributor: Pfizer Inc.
Study ID: NCT02384382
Sponsor ID: NCT02384382
Summary of Results:
We were unable to bring our analysis to completion because the data was anonymized in a different manner than the images and thus, we could not correlate the PSA with the imaging.