Introduction: To determine clinical and biopsy features with predictive capacity to identify pathologically insignificant prostate cancer (pIPCa). Material and Methods: pIPCa was defined as cancer volume <0.5 cm3 and a Gleason score (GS) of ≤6 in radical prostatectomy (RP) specimens. Clinical and biopsy parameters were studied as predictors of pIPCa and validated by applying them to d’Amico’s low-risk cases: T1c-T2a, prostate-specific antigen (PSA) <10 and biopsy GS ≤6. Appropriate cut-offs were selected. Results: 280 patients were evaluated; 11.8% (33) had pIPCa, increasing to 23% in low-risk cases. In patients fulfilling d’Amico’s low-risk criteria, variables significantly different in pIPCa were: volume, number of positive cylinders (NPC), percentage of positive cylinders (%PC), percentage of the most affected cylinder (%MAC) and uni/bilaterality. In these cases, volume and the NPC increased as independent variables on logistic regression and when adding a volume threshold of 45 cm3 and 1 positive core, specificity reached 95.8%. Conclusions: The incidence of pIPCa in RP specimens is relevant, especially in low-risk cases. Prostate volume and NPC are independent predictors of pIPCa. We propose a simple predictive model by adding the features of 1 positive core and volume ≧45 cm3 to d’Amico’s criteria. This allows to preoperatively distinguish between patients that most probably would benefit from radical treatment and patients that might be offered active surveillance.

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