NADiA ProsVue Prostate-specific Antigen Slope, CAPRA-S, and Prostate Cancer–specific Survival After Radical Prostatectomy

Objective To assess whether NADiA ProsVue prostate-specific antigen slope, a prognostic biomarker for identifying men at a reduced risk of clinically recurrent prostate cancer after radical prostatectomy, is prognostic for prostate cancer–specific mortality (PCSM) and other outcomes. Materials and Methods We examined long-term outcome in the cohort of 304 men selected for the ProsVue 510(k) clinical trial. We assessed the prognostic value of a ProsVue result ≤2.0 pg/mL/mo and pathologic risk stratified by the Cancer of the Prostate Risk Assessment Postsurgical nomogram for a reduced risk of prostate cancer–specific survival. We also assessed its value for predicting clinical outcome in men given salvage treatment for biochemical recurrence. Efficacy was assessed using univariate and multivariate Cox regression and the Kaplan-Meier analyses. Results Median (interquartile range) overall survival for the groups of men with a ProsVue slope result ≤2.0 and >2.0 pg/mL/mo were 11.0 (9.4-12.9) and 9.2 (4.9-11.6) years, respectively. The ProsVue univariate hazard ratio (95% confidence interval) for PCSM was 20.6 (6.8-62.7), with P 2.0 pg/mL/mo vs a result ≤2.0 pg/mL/mo. The multivariate hazard ratio of ProsVue adjusted by Cancer of the Prostate Risk Assessment Postsurgical nomogram remained significant (16.7 [4.7-58.6]; P