Results published of PROPOSe, a real-life prospective study of Proclarix, a novel blood-based test to support challenging biopsy decision making in prostate cancer
Zurich-Schlieren, Switzerland, January 07, 2021 – Proteomedix, the Swiss cancer diagnostics company, announced today that the results of PROPOSe, a prospective multicenter study of Proclarix® in clinical routine use, were published in European Urology Oncology1).
Prostate specific antigen (PSA)-based detection of prostate cancer (PCa) often leads to negative biopsy results or detection of clinically insignificant PCa. The PROPOSe study was initiated to evaluate the accuracy of Proclarix, a novel blood-based diagnostic test to help in biopsy decision making. Ten clinical sites in Germany, Denmark and Austria prospectively enrolled 457 men presenting for prostate biopsy.
“This prospective study confirmed Proclarix performance as established during CE validation“, commented Dr. Ralph Schiess, CSO and co-founder of Proteomedix. Proclarix detected clinically significant cancer with high sensitivity above 90% and reliably ruled out patients with no or indolent cancer with a negative predictive value greater than 90%. When the biopsy performed was guided by MRI (magnetic resonance imaging), both sensitivity (97%) and NPV (96%) were even higher. Importantly, Proclarix was significantly superior to the current clinical standard percent free PSA in ruling out unneeded biopsies (22% vs. 14%) and the primary study endpoint was met (p-value < 0.005).
Prof. Dr. med. Thomas Steuber from the renowned Martini-Klinik Hamburg and principal investigator of the study stated: “In a routine use setting, Proclarix accurately discriminated clinically significant PCa from no or indolent PCa. This study provides strong support for the use of Proclarix in routine practice to improve the biopsy decision algorithm.”
Co-investigator Prof. Dr. med. Carsten Ohlmann from the Johanniter Krankenhaus Bonn added: “Proclarix is a novel blood-based test with the potential to accurately rule out no or insignificant cancer, and therefore to reduce the number of unneeded biopsies.”