“Correlation with high-grade cancer is an important finding, as it shows the potential to lower overdiagnosis and overtreatment when using ProteoMediX test in men scheduled for biopsies”, stated Prof. Dr. Helmut Klocker, study investigator from the Medical University of Innsbruck, presenting the study results at this year’s EAU congress in Copenhagen, Denmark. His work was awarded the Best Poster presentation of its session.
The PSA (prostate-specific antigen) test is used routinely in prostate cancer diagnosis and often leads to over-diagnosis (false positive results), especially in men with enlarged prostates. The retrospective study included 483 samples collected from men before a prostate biopsy at the Medical University of Innsbruck, Austria.
ProteoMediX’ test showed a high correlation with prostate cancer aggressiveness and at the same time demonstrated that the use of the test could avoid a large number of biopsies. The test was validated through an independent cohort of 474 samples taken from patients undergoing biopsies at the Martini-Klinik, Hamburg, Germany. Similar to the observations made at the Medical University of Innsbruck, the test showed a high sensitivity of 90% for high-grade (Gleason Score >6) prostate cancer with a negative predictive value (NPV) of 93%, making it very likely that a case of aggressive cancer will not be missed. In addition, 152 (41%) out of 368 biopsies with no or low-grade cancer could have been avoided using the test.
Prof. Dr. Thomas Steuber, co-investigator from the Martini-Klinik Hamburg added: “Patients investigated in this study with enlarged prostates and often false positive PSA test results are one of the most difficult groups to diagnose with prostate cancer. Here we showed that ProteoMediX’ test has the potential to avoid prostate biopsies while accurately predicting significant prostate cancer.”