The malignancy index is a robust predictor of prostate cancer

The objective of this study was to validate the results from our published work and to test the robustness of our unique malignancy index as a (non-invasive) predictor of prostate cancer in fresh blood samples obtained from patients diagnosed with prostate cancer (PCa), benign prostatic hyperplasia (BPH), and healthy volunteers (Controls). The malignancy index was obtained by dividing the product of three biomarker values, [urokinase plasminogen activator (uPA), plasminogen activator inhibitor type-1 (PAI-1), and prostate-specific antigen (PSA)], by the age of the patient/healthy volunteer, using enzyme-linked immunosorbent (ELISA) assay methodology. The results confirmed earlier findings that the malignancy index discriminates prostate cancer from non-prostate cancer. The index significantly separated the PCa group from the Control group with values of 0.0701 (n=54) and 0.0007 (n=47), respectively, by a factor of 100. The malignancy index of the small BPH cohort was found to be 0.0016 (n=20), differing by a factor of 44 from the Control group. When data from the earlier study and the current study data were collectively analyzed, the index again significantly separated the PCa group from the Control group by a factor of 15, with values of 0.0624 (n=125) and 0.0042 (n=110), respectively. However, the same could not be said of the BPH data since the sample size (n=20) was well below par, for comparison. In the initial blood study, the PCa group was significantly separated from the Control group by a factor of 8.5. The data presented here concur with findings in needle biopsies and transurethral resection tissue, reported elsewhere (Bohm et al., 2013; Akudugu et al., 2015). At this preliminary stage, the malignancy index has potential and merit as a prostate cancer biomarker.