Urinary proteome analysis for prostate cancer diagnosis: cost-effective application in routine clinical practice in Germany

Objectives: Capillary electrophoresis mass spectrometry urinary proteome analysis for prostate cancer has been shown to be highly accurate in the detection of prostate cancer. The aim of the present study was to report our experience with routine application of this test in clinical practice and its cost‐effectiveness. Methods: The urinary proteome analysis for prostate cancer test was carried out in 211 patients in outpatient centers. In 184 of them, data about their follow up and the test results were available for analysis. Prostate cancer was detected in 49 cases. Results: The test correctly recognized 42 out of 49 tumor patients, showing a sensitivity of 86% (95% confidence interval 73–94). Of 135 prostate cancer‐negative patients, 79 had a negative urinary proteome analysis for prostate cancer test (specificity 59% [79/135 95% confidence interval 50–66]). Negative and positive predictive values were 92% (95% confidence interval 84–96) and 43% (95% confidence interval 33–53), respectively. A statistically significant (P < 0.0005) improvement in terms of diagnostic accuracy was observed in comparison with serum prostate‐specific antigen and percent‐free prostate‐specific antigen. Whereas the urinary proteome analysis for prostate cancer test results agreed in 65.7% with follow‐up reference results, prostate‐specific antigen achieved 33.3% and percent‐free prostate‐specific antigen achieved 42.7%. Cost‐effectiveness analysis showed that the urinary proteome analysis for prostate cancer strategy outperformed the biopsy approach as well as prostate‐specific antigen tests. Conclusions: The non‐invasive urinary proteome analysis for prostate cancer test appears to be a helpful addition to prostate cancer diagnostics for patients with suspicious prostate‐specific antigen and/or digital‐rectal examination.