To assess whether cell-cycle progression (CCP)-score (Prolaris) can improve the current risk assessment in newly diagnosed PCa patients. CCP-score is a well validated prognostic assay predictive of PCa death, biochemical recurrence (BCR) and progression.

We evaluated CCP-score at biopsy in 52 patients newly diagnosed with PCa who underwent radical prostatectomy. CCP-score was calculated as average RNA expression of 31 CCP genes, normalized to 15 housekeeping genes. The predictive ability of CCP-score was assessed in univariate and multivariate analyses, and compared to that of Ki-67 levels and traditional clinical variables including PSA, Gleason score, stage, and percentage of positive cores at biopsy.

In spite of an overall good accuracy in attributing the correct risk class, seven high-risk and thirteen intermediate-risk patients were misclassified by Prolaris test. On ANOVA, mean CCP-score significantly differed across different risk classes based on pathologic results (-1.2 in low-risk, -0,444 in intermediate-risk, 0.208 in high-risk). CCP-score was a significant predictor of high-risk PCa both on univariate analysis and in multivariate analyses, after adjusting for clinical variables. Combining CCP-score and the EAU clinical risk assessment improved the accuracy of risk attribution of around 10%, up to 87.8%. CCP-score was a significant predictor of BCR, but only on univariate analysis.

The CCP-score might provide important new information to risk assessment of newly diagnosed PCa in addition to traditional clinical variables. A correct risk attribution is essential to tailor the best treatment for each patient.