Summary: | 1. For men with higher probability of prostate cancer, as reflected by PSA testing or rectal examination, diagnostic accuracy increases somewhat by adding the uPCA3 test. The higher the uPCA3 value, the higher the probability of cancer. A uPCA3 result above the threshold value implies a strong suspicion of prostate cancer. In some otherwise difficult-to-assess patients the test would contribute towards earlier biopsy and earlier diagnosis. The uPCA3 test cannot, however, rule out prostate cancer in men having a higher probability of the disease. Accuracy of the uPCA3 test is the same regardless of whether the individual has had a previous biopsy with negative results, or has never had a biopsy.2. The addition of the uPCA3 test to determine which patients should be biopsied involves a higher total cost than direct prostate biopsy of all men with an increased probability of prostate cancer as identified by PSA testing or rectal examination.3. The importance of the uPCA3 test in further investigation and its effects on disease course and mortality should be assessed in clinical studies. To appraise the patient benefits of routine clinical use of uPCA3, better evidence is needed regarding the value of the extra information obtained from the test results in relation to other risk factors, e.g. PSA concentration, age, rectal examination, and the results of previous biopsies.4. The scientific evidence is insufficient to appraise the diagnostic accuracy of TMPRSS2:ERG and me-GSTP1 urine tests. Further studies are needed
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