Increased prostate volume due to benign disease leads to many false-positive PSA (prostate specific antigen) results and consequently to negative prostate biopsies. A retrospective study was conducted in 474 serum samples collected from men undergoing prostate biopsy at the Martini-Klinik, Hamburg, Germany. Thomas Steuber, MD at the Martini-Klinik, and professor at the University Hospital Hamburg-Eppendorf presented the recent clinical study results at the annual EAU (European Association of Urology) congress 2017 in London, UK. At 90% sensitivity for prostate cancer, the specificity was 60% indicating that 141 of 236 negative biopsies could have been avoided.
As a conclusion, in patients with elevated PSA, negative DRE and enlarged prostate, ProteoMediX’ test was significantly more accurate than percent free PSA alone in determining the absence of prostate cancer.
Dr. Ralph Schiess, CEO and co-founder of Proteomedix commented: “We are very pleased with the latest results. It shows that the implementation of the test in clinical practice has the potential to significantly lower the rate of prostate biopsies which are negative for prostate cancer by more than 50%.” “We are looking forward to further validate these positive findings in independent clinical studies.”, said Christian Brühlmann, CFO/CBO and co-founder of ProteoMediX.
ProteoMediX’ test combines the measurement of the two proteins cathepsin D (CTSD) and thrombospondin 1 (THBS1). The combination of the two proteins CTSD and THBS1 yielded an AUC (area under the curve) of 0.834 (P <0.001; 95% CI = 0.797-0.871); and when combined with percent free PSA (ratio of free to total PSA), it resulted in an even higher AUC of 0.845 (P <0.001; 95% CI = 0.810-0.880).
Additional details on the study are available on the website of the annual EAU congress 2017. The respective poster can be downloaded here.