Current evidence and future perspectives about the role of iXip® in the diagnosis of prostate cancer.

iXip® (Immune CompleX Predictive Index, Xeptagen, Venice, Italy) is a diagnostic tool which biological bases ground on PSA-IgM complexes. An algorithm merges the data of PSA-IgM and serum total PSA dosage, prostate volume and patient's age, providing as output a numerical value that correlates with the risk of finding prostate cancer (PCa) at biopsy. The present paper reviews the available evidence and explores future perspective on iXip. A few studies consistently showed that iXip offers better diagnostic accuracy in the diagnosis of PCa than every single parameter composing the index. In detail, for values of iXip below 20% prostatic biopsies were invariably negative, between 20% and 30% only one out of 10 patients had cancer, generally Gleason Score 6, whereas for iXiP>30% the detection rate raised up to 35% and comprised the majority of Gleason score >6 cancers. The PROXIMA study is an ongoing prospective trial that should assess the predictive ability of iXip towards the presence of a clinically significant PCa defined at radical prostatectomy, accounting for clinical, multiparametric magnetic resonance and bioptic data. Preliminary data showed that for iXip values <20% prostatic biopsy could be safely omitted and that the diagnosis of Gleason Score >6 PCa is unlikely for values below 30%.