Statistical methods
bone disease
BONE DISEASE, REGRESSION
The coefficient of repeatability of apparent diffusion coefficient measurement for bone disease on DWI has been reported to be approximately 15% (The primary outcome was the response rate in the evaluable population according to whole-body DWI, defined as a 30% increase in global median apparent diffusion coefficient (Analyses were conducted in the evaluable population, defined as patients who were evaluable for the parameters of interest. Patients with ineligibility deviations were discussed with the independent data monitoring committee on a case-by-case basis; those with deviations likely to affect assessment of the primary endpoint were excluded. Dose groups were combined for analysis unless otherwise specified. Response rates are presented with 2-sided 95% confidence intervals (CIs). The 2-sided 90% confidence interval for the primary outcome is also presented, equivalent to a 1-sided 95% confidence interval per the sample size calculation. Agreement between responses according to different imaging modalities was assessed using Cohen κ. The association between responses according to imaging modalities and blood markers was assessed using the Fisher exact test and logistic regression modeling, with adjustment for minimization balancing factors. Receiver operating characteristic analysis was carried out to explore the relationship between continuous global apparent diffusion coefficient change and other markers of response. Time to ALP or PSA progression and overall survival were assessed using standard Kaplan-Meier methods. The association between response and dose level was assessed using logistic regression. The association with dose was also assessed on a per-lesion basis using a multilevel model with random effect for patient and fixed effect for dose group. All tests of statistical significance were 2-sided (unless otherwise stated), and a cutoff of 5% was used to determine significance.Analyses were conducted using Stata, version 16.1, statistical software (StataCorp LP, College Station, TX) and based on a snapshot of data taken on January 14, 2021. Overall survival data were updated in April 2022.