Table 1.
Summary of baseline demographic data and laboratory values of subjects included in model development.
Table 2.
Parameter estimates of the final PSA kinetics model.
Fig 1.
Profiles of PSA kinetics in representative patients with hormone-sensitive prostate cancer.
Black line represents model-predicted PSA levels. Open circles and solid circles represent observed PSA levels above the lower limit of quantification (LLOQ) and observed PSA levels below the LLOQ, respectively. Red and green vertical dashed lines represent the first and the last recorded date of leuprorelin treatment, respectively. Blue horizontal dotted line represents the LLOQ value of the PSA assay. Black arrows represent the fill dates of leuprolide.
Fig 2.
Diagnostic plots for the final disease progression model.
From left to right and top to bottom: Observed log PSA concentrations (DV) versus individual log predicted values (IPRED), individual weighted residuals (IWRES) versus the IPRED, IWRES versus time, and expected conditional weighted residuals (ECWRES) versus the expected log predicted values (EPRED). The red line represents the loess regression line.
Fig 3.
Simulation results for percentages of subjects with PSA progression within one, two, and three years.
3A and 3B show simulated PSA progression in subjects with 5th percentile, median and 95th percentile of hemoglobin level and baseline PSA level, respectively.
Fig 4.
Simulated total PSA and PSA produced by drug-sensitive and drug-resistant tumor cells in representative subjects.
4A and 4B demonstrate simulated PSA levels in a “responder” Subject A and a “partial responder” Subject B, respectively. Black line represents model predicted total PSA level. Pink and grey solid lines represent model predicted PSA from drug-sensitive and drug-resistant tumor cells, respectively. Red and green vertical dashed lines represent the first and the last recorded date of leuprorelin treatment, respectively. Blue horizontal dotted line represents the lower limit of quantification (LLOQ) of the PSA assay.