OBJECTIVES:  Improving the accuracy of risk stratification at diagnosis is an important goal in prostate cancer (PCa) research. This study aims to assess the cost-utility of Prolaris, a biopsy tissue-based cell cycle progression (CCP) assay, in the risk assessment of PCa patients with a positive biopsy, from the Canadian healthcare system perspective. METHODS:  A Markov model was used to estimate the quality adjusted life years gained (QALYs) and costs for three strategies (standard 12-core TRUSGB, MRI-guided biopsy (MRGB) and standard TRUSGB plus Prolaris) over 5, 10, 15 and 20 years. The model takes into account the accuracy of diagnostic tests and the probability of assignment to various treatment options. We assumed that patients re-categorized with Prolaris to very low risk PCa will be placed on active surveillance. Direct medical costs based on the Quebec healthcare system’s perspective were included. RESULTS:  The difference in QALYs between TRUSGB + Prolaris and TRUSGB ranged from 0.01 to 0.11, with the highest difference observed over the 20-year time horizon. The corresponding values of the cost difference ranged from 1,900CAD and 1,000CAD. In addition, no benefit in QALY was observed between the TRUSGB + Prolaris strategy and the MRGB strategy. However, a higher cost was observed in the TRUSGB + Prolaris strategy (between 2,300CAD at 5 years and 4,300CAD at 20 years). The cost-utility analysis revealed an incremental cost-utility ratio (ICUR) as high as 190,000CAD/QALY at 5 years and as low as 9,200CAD/QALY at 20 years. CONCLUSIONS:  Our preliminary results suggest that the incorporation of Prolaris in PCa diagnosis represents a cost-effective measure over a 10-, 15- and 20-year time horizon compared TRUSGB alone, with an ICUR below the threshold of 50,000CAD. However, the TRUSGB + Prolaris strategy was costlier and less effective than the MRTB strategy.