More than 20-years experience of PSA use for PCa screening has lead to a life expectancy growth and reduction of mortality in PCa patients. On the other side, widespread use of PSA resulted in some negative implications, such as high number of false-positive results and unnecessary biopsies, PCa hyper diagnosis and unnecessary treatment. РСА3 and TMPRSS2-ERG are between the most promising biomarkers. Both РСА3 and TMPRSS2-ERG demonstrate higher specificity and sensitivity, compared to serum PSA. Combination of these two markers may lead to a better diagnostic accuracy, with 73-80% sensitivity and 90% specificity. Combined РСА3 and TMPRSS2-ERG detection in urine is useful in prediction of prostate biopsy outcomes (i.e. PCa presence, Gleason score). РСА3 and TMPRSS2-ERG expression assessment in prostate tissue may be helpful for PCa detection in cases, when the results of histological examination are negative.

Therefore, a combination of РСА3 and TMPRSS2-ERG seems to be hopeful. Thus, there are still some outstanding issues and further studies needed to determine a cut-off score for PCA3 in a combined test and to work out standard recommendations on РСА3 and TMPRSS2-ERG diagnostic tool clinical use. The role of РСА3 and TMPRSS2-ERG combination in a prostate cancer course prediction should also be carefully investigated. Besides, there is a need for costeffectiveness trials to figure out if РСА3 and TMPRSS2-ERG combined test should be recommended for widespread use.

Purposely to the improvement of PCa early detection, a diagnostic system for РСА3 and TMPRSS2-ERG determination in urine and prostate tissue was developed at Russian State Scientific-research Institute of Urology. The diagnostic system is passing through clinical trials at present.

-ERG combined test should be recommended for widespread use. Purposely to the improvement of PCa early detection, a diagnostic system for РСА3 and TMPRSS2-ERG determination in urine and prostate tissue was developed at Russian State Scientific-research Institute of Urology. The diagnostic system is passing through clinical trials at present.