A clinical study coordinated by Dr. Zani, Clinic of Urology, Brescia University, Italy, validating Xeptagen's biomarker PSA-IgM for prostate cancer diagnosis has been presented at the Centennial Congress of the Italian Society of Urology held in Rome 22-28 September 2008. In the study the diagnostic value of PSA-IgM immune complexes has been assessed in the serum samples of 28 patients with prostate cancer and 30 patients with benign hypertrophy. Serum levels of PSA-IgM were compared to circulating total PSA by using a predetermined specificity of 80% to discriminate patients affected by benign prostatic hyperplasia. The assessment of serum levels of PSA-IgM allowed a 3-fold improvement in the detection of prostate cancer confined to the gland compared to the analysis of total PSA. In addition the combination of PSA-IgM and total PSA was found to give the best tumor identification rate. The results of the study confirmed the importance of PSA-IgM assay for the diagnosis of organ-confined prostate cancer.