ASSOCIATION BETWEEN TUMOR VOLUME AND UNFAVORABLE PROSTATE CANCER CHARACTERISTICS: IMPLICATIONS FOR PATIENT STRATIFICATION Introduction. Previous studies showed that the tumor volume (TV) might increase the ability to identify patients with insignificant prostate cancer (PCa). However, these results were obtained using preoperative imaging modalities, which might lead to an under- or overestimation of the actual TV. The aim of our study was to test the role of pathological TV on the risk of unfavorable characteristics at final pathology in patients treated with radical prostatectomy (RP). Methods. Overall, 3,193 patients with PCa treated with RP between February 2005 and August 2013 at a single tertiary referral center were identified. All patients had available preoperative and pathological data. TV was calculated by visual inspection, according to the College of American Pathologists guidelines. Uni- and multivariable logistic regression analyses tested the impact of tumor volume (continuously coded) on the risk of pathological Gleason score 8-10, seminal vesicle invasion (SVI), and lymph node invasion (LNI) in the overall population, and after stratifying patients according to the D’Amico risk groups. Covariates consisted of preoperative PSA, clinical stage, and biopsy Gleason score. Results. Mean patient age was 62.5 years (median: 63). Mean tumor volume was 4.8 ml (median: 2.8). Overall, 1,200 (37.6%), 1,406 (44.0%), and 587 (18.4%) patients had low-, intermediate- and high-risk PCa, respectively. Overall, 392 (12.3%), 367 (11.5%), and 325 (10.2%) patients had pathological Gleason score 8-10, SVI, and LNI, respectively. In multivariate logistic regression analyses, TV was associated with increased risk of pathological Gleason score 8-10, SVI, and LNI, after accounting for confounders (all P<0.001). This held true after stratifying patients according to the risk groups (all P<0.001). Particularly, TV represented an independent predictor of pathological Gleason score 8-10, SVI, and LNI even in patients with low-risk PCa, after accounting for preoperative PSA (all P<0.001). Conclusions. Pathological TV represents an independent predictor of unfavorable pathological characteristics in PCa patients. These results support the importance of preoperative assessment of tumor volume in order to identify patients at higher risk of more aggressive disease at final pathology.