RESUMO
BACKGROUND: Transrectal ultrasound-guided biopsy (TRUS-Bx) is recommended by the European Urology Association (EAU) as the first diagnostic modality for men at risk of prostate cancer (PCa). Current EAU guidelines reserve the use of multiparametric MRI to target or guide any repeat biopsy (mpMRI-Bx). It remains uncertain if TRUS-Bx is effective as a first strategy in terms of costs, diagnostic performance, time to diagnosis, and triage for individualised therapy. OBJECTIVE: To determine the diagnostic and treatment costs and the effectiveness of pathways incorporating mpMRI-Bx compared to TRUS-Bx in men at high risk of PCa. DESIGN, SETTING, AND PARTICIPANTS: A cost and time analysis was performed using data from a randomised single-centre study of 1140 patients (prostate-specific antigen >4ng/ml) divided into two groups: 570 patients underwent an initial TRUS-Bx and 570 underwent 3-T mpMRI-Bx. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Budget analyses were used to compare the diagnostic strategies using reimbursement data from the Italian National Health Security system. Analyses of reimbursable diagnostic and treatment costs were undertaken separately. Histologic outcomes, pathway diagnostic accuracy, therapy choices, and time to diagnosis were compared. RESULTS AND LIMITATIONS: The cumulative diagnosis costs were 14.6% greater for the mpMRI-Bx pathway than for the TRUS strategy, and 5.2-6.0% higher for therapy. Diagnostic costs were 228 946 for mpMRI-Bx and 199 750 for TRUS-Bx, and the corresponding therapy costs were 1 912 000 and 1 802 800. The mpMRI-Bx strategy was highly effective in excluding clinically significant disease (Gleason ≥7; sensitivity and negative predictive value both 100%, 95% confidence interval 98-100%). The time to diagnosis was significantly shorter for the mpMRI-Bx (median 4.0 mo interquartile range [IQR] 3-6) than for the TRUS-Bx strategy (median 6 mo, IQR 4-12; p<0.001). Limitations include the lack of data on costs associated with treatment-related complications and follow-up data. CONCLUSIONS: The mpMRI-Bx strategy is effective for diagnosing patients with a clinical suspicion of PCa and provides more accurate diagnosis, with combined diagnosis and therapy costs only moderately higher than for the standard strategy. PATIENT SUMMARY: It is a matter of debate whether a diagnostic pathway that incorporates multiparametric magnetic resonance imaging (MRI) as the first-line test before performing any type of biopsy in men suspected of having prostate cancer (PCa) is cost-effective. Our analysis of the costs for men suspected of harbouring PCa revealed higher diagnostic costs for the MRI approach, with the benefits of greater diagnostic accuracy. Moreover, the combined diagnostic and treatment costs are only modestly higher whenever the same treatment for all patients is considered.