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Minerva Urologica e Nefrologica 2019 June;71(3):201-4

DOI: 10.23736/S0393-2249.19.03329-0


language: English

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

Alessandro ANTONELLI 1 , Simone FRANCAVILLA 1, Andrea GALLOTTA 2, Luigi F. DA POZZO 3, Stefania FERRETTI 4, Sandra SIGALA 5, Claudio SIMEONE 1, Vincenzo MIRONE 6, Walter ARTIBANI 7, Angelo PORRECA 8

1 Department of Urology, ASST Spedali Civili, Brescia, Italy; 2 Xeptagen S.p.A., VEGA Science Park, Venice, Italy; 3 Department of Urology, ASST Papa Giovanni XXIII, Bergamo, Italy; 4 Department of Urology, Parma University Hospital, Parma, Italy; 5 Section of Pharmacology, Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy; 6 Department of Urology, Federico II University, Naples, Italy; 7 Clinic of Urology, Department of Oncological and Surgical Sciences, Verona University Hospital, University of Verona, Verona, Italy; 8 Department of Urology, Abano Terme General Hospital, Padua, Italy

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%.

KEY WORDS: Immune complex diseases; Prostatic neoplasms; Biopsy; Diagnosis; Biomarkers

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