Value of NADiA ProsVue on the CAPRA-S nomogram for predicting postprostatectomy clinical recurrence.
Moul, JW; Lilja, H; Lance, R; Vessella, R; McDermed, JE; Sarno, MJ; Adams, TH
Published in: Journal of Clinical Oncology
139 Background: The post-radical prostatectomy (RP) CAPRA-S nomogram stratifies men into low, intermediate and high risk groups for biochemical recurrence (BCR) and proved accurate for predicting 3 and 5 year BCR rates in a large study cohort. NADiAProsVue is a prognostic test that identifies men at reduced risk of clinically recurrent prostate cancer when used with traditional risk factors. We assessed ProsVue, a prognostic test for identifying post-RP clinical recurrence, in an independent population of men classified into low, intermediate and high CAPRA-S risk groups. Methods: The 304 men in the ProsVue 510(k) study were categorized into low (scores 0-2), intermediate (3-5) and high (≥6) CAPRA-S risk groups. Men were categorized as “at reduced risk” or “not at reduced risk” using a 2.0 pg/mL/month ProsVue cutpoint. Clinical recurrence was defined by positive biopsy or imaging results or death due to prostate cancer. Clinical progression-free survival (cPFS) was determined between subgroups using univariate Cox regression and Kaplan-Meier survival analyses and Wilcoxon and log-rank p values were reported. Results: Recurrence occurred in 8/156 (5.1%), 20/93 (21.5%) and 32/55 (58.2%) of men in the low, intermediate, and high CAPRA-S risk groups, respectively (P<0.0001). After 3, 5, 8 and 15 year followup, men in all CAPRA-S risk groups with ProsVue results ≤2.0 had significantly longer cPFS compared to men with results >2.0. The differences are marked as early as 3 years post-RP in the intermediate and high risk groups. Conclusions: ProsVue added significant prognostic value for identifying risk of clinical recurrence within low, intermediate and high CAPRA-S risk groups. ProsVue is the strongest independent predictor of clinical recurrence of prostate cancer post-RP. [Table: see text]