Clinical economic justification of a strategy of determination of PCA3 in urine for diagnosis of prostate cancer

Sivkov A.V., Kaprin A.D., Efremov G.D., Mihaylenko D.S., Grigor'eva M.V.

Relevance. PCA3 demonstrated a high diagnostic value in relation to prostate cancer. The few studies of clinical and cost-effectiveness of PCA3 dedicated to costly test "Progensa". Economic aspects of the use of other methods of assessment of PCA3 expression has not been studied. 

The aim of this study was to investigated the diagnostic significance of the evaluation method of the expression of PCA3 in urine, suggested in the Research Institute of Urology and based on the real-time PCR followed by evaluation of the economic feasibility for determining the expression of PCA3 in the urine and the development of strategy for its integration into the practice. 

Material and methods. Analyzed post massage urine samples were obtained from 110 men (44-85 years). We have evaluated the level of serum PSA, pathologic data and expression of PCA3 in the urine. 

Economic feasibility for the inclusion of PCA3 in the prostate cancer diagnostic algorithm was evaluated by economic modeling using the decision curve analysis. 

Results. Threshold level for PCA3 in the urine was defined as ≤ 1.23, which is consistent with the diagnostic accuracy of 81.8%, sensitivity of 76.3%, specificity of 88.2% and AUC 0.879 with 95% CI(0.803-0.933). 

Economic simulation (10,000 people) demonstrated that the use of the scheme including the determination of the PCA3 for the diagnosis of PCA is more economically feasible in comparison with the standard scheme (with PSA levels of 4-10 ng/ml). The proportion of unjustified costs on the biopsy in standard diagnostic model (24 024 931.52 RUB) will be much higher in comparison with the diagnostic model including PCA3 in the urine (5 099 113,04 RUB). By eliminating unnecessary biopsies via using PCA3 the estimated benefits will be RUB 11080706,68. 

Conclusions. It is demonstrated that, despite the higher cost in comparison with the use of the serum PSA, РСА3 in the urine is a more reliable marker, and allows to reduce the cost of early diagnosis of prostate cancer in patients with PSA levels of 4-10 ng/ml by eliminating unnecessary biopsies. 

Authors declare lack of the possible conflicts of interests. 

AttachmentSize
Download837.79 KB
prostate cancer, diagnostics, molecular-genetic test, PCA3, clinical and economic analysis