Introduction: To identify risk factors for biochemical failure after radical prostatectomy (RP) in men with pathologically organ-confined (OC) prostate cancer (PCa). Materials and Methods: Clinical and pathological features of 350 consecutive patients with pathologically OC PCa treated only with RP and bilateral pelvic lymphadenectomy were analyzed, retrospectively, to identify predictor parameters of prostate-specific antigen (PSA) failure (PSA ≧0.4 ng/ml). The median follow-up was 58.6 months (range: 3.9–183 months). All pathological specimens were step sectioned at 4-mm intervals. Kaplan-Meier progression-free survival rates and χ2 test were adopted for statistical analyses. Multivariate Cox proportional hazard regression models were used to test the association between pathological Gleason score and surgical margin status. Results: 67 patients (19.1%) failed at a median follow-up of 40.2 months (range 1.9–123.3). Age and preoperative PSA failed to reveal significance also in patients with serum PSA ≧20 ng/ml (p = 0.46). Patients with T3 clinical stage had a higher progression rate compared to T1C and T2 (43.5 vs. 27.8 and 17.3%, respectively) even if no high statistical significance was pointed out. Presence of perineural infiltration (p = 0.04) and prostatic apex infiltration (p = 0.74) in the prostatectomy specimens failed to reveal significance. A high pathological Gleason score (≧7; p = 0.0003) and surgical margin status (p < 0.0001) were shown to be the most powerful predictive parameters of biochemical progression. Conclusions: In patients with pathologically OC PCa the presence of a high pathological Gleason score and positive surgical margins appear to represent the most important factors for prediction of outcome following RP.

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