Abstract
IntroductionThe Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa) diagnosis that integrates PSA, PSA-IgM, prostate volume, and patient age. The aim of the study was to assess the correlation between iXip and clinically significant PCa in patients who underwent radical prostatectomy.Material and MethodsA prospective multicenter study was conducted from February 2018 to August 2019 enrolling 235 patients. Stepwise-selected predictors were used to estimate multivariate regression models for each outcome, the reference model with only the set of predictors and the same model with the addition of iXip. The prediction accuracy of the two models was assessed calculating the partial area under the receiver operating characteristic curve.ResultsThe ROC curve analysis showed significant differences in terms of partial area under the curve between iXip and pathological Gleason Score ≥ 7 and between iXip and tumor volume ≥ 2.5 mm3. The scatter plot analysis showed a positive linear correlation between iXip and tumor volume (considered as a continuous variable). The subpopulations with pT3–4 disease and cT3 disease and with positive surgical margins showed a significant linear relationship between iXip and tumor volume.ConclusionWe found elements supporting a possible correlation between iXip and aggressive PCa in terms of Gleason Score ≥ 7 and tumor volume ≥ 2.5 mm3.
Highlights
The Immune compleX Predictive Index is a predictive tool for prostate cancer (PCa) diagnosis that integrates prostate specific antigen (PSA), PSA-IgM, prostate volume, and patient age
Investigating the ability of iXip to identify patients with pathological Gleason Score (pGS) ≥7, we found that the area under the receiver operating characteristic (ROC) curve of the reference logistic model without iXip was 0.85; the addition of iXip to the model only slightly increased the AUC to 0.86 (p = 0.2)
The design of the current study goes above and beyond the previous research, investigating in depth the predictive ability of the PCa biological aggressiveness from a different perspective. iXip has been evaluated to account for comprehensive clinical data and bioptic features, referring to the description of PCa as a final pathology of radical prostatectomy
Summary
The Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa) diagnosis that integrates PSA, PSA-IgM, prostate volume, and patient age. The aim of the study was to assess the correlation between iXip and clinically significant PCa in patients who underwent radical prostatectomy. The iXip (Immune CompleX Predictive Index, Xeptagen, Venice, Italy) is a diagnostic integrated tool designed to improve the predictive performance of the PSA-IgM immune complexes only merging these data with serum PSA value, prostate volume, and patient’s age [11, 12]. Based on the association of iXip with some biological features of PCa, we designed a prospective multicenter study (the Proxima trial) that aims to assess whether preoperative iXip can predict clinically relevance of PCa, as defined on pathological features available at radical prostatectomy specimen
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