Judd W Moul1, Mark J Sarno2, Jonathan E McDermed3, Melissa T Triebell3, Mark A Reynolds4. 1. Division of Urologic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC; Duke Cancer Institute, Durham, NC. Electronic address: judd.moul@duke.edu. 2. Vision Biotechnology Consulting and Vision Clinical Research, Escondido, CA. 3. Arista Molecular, IRIS Personalized Medicine, Carlsbad, CA. 4. Product Development Department, Beckman Coulter Diagnostics, Brea, CA.
Abstract
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 <.0001 for a ProsVue result >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 <.0001). The inverse of the hazard ratio translates to a 94.0% risk reduction for PCSM for men with a ProsVue result ≤ 2.0 pg/mL/mo. Salvage treatment for biochemical recurrence did not significantly reduce the hazard of clinical recurrence or PCSM; however, this is based on only 18 events. CONCLUSION: A NADiA ProsVue slope result ≤ 2.0 pg/mL/mo was prognostic for a reduced risk of PCSM in men 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 <.0001 for a ProsVue result >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 <.0001). The inverse of the hazard ratio translates to a 94.0% risk reduction for PCSM for men with a ProsVue result ≤ 2.0 pg/mL/mo. Salvage treatment for biochemical recurrence did not significantly reduce the hazard of clinical recurrence or PCSM; however, this is based on only 18 events. CONCLUSION: A NADiA ProsVue slope result ≤ 2.0 pg/mL/mo was prognostic for a reduced risk of PCSM in men after radical prostatectomy.