Clinical validation of the iXip index in avoiding unnecessary prostate biopsy: Results from a prospective multicenter study involving 426 patients

Gallotta, Andrea; Giannarini, Gianluca; Laurini, L.; Zani, Danilo; Gaspar, António; Guazzieri, S.; Plebani, Mario; Fassina, Giorgio; Zattoni, Filiberto

doi:10.1016/j.ctarc.2017.01.002

Cited by 5 publications

(8 citation statements)

References 19 publications

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“…The first is a multicentric study including 426 patients who were candidates for first biopsy showing that iXip values were significantly higher in PCa patients and iXip values lower than 20% corresponded to 0 patients with PCa. In this study, the authors also showed a significant correlation between iXip and biopsy Gs [48].…”

Section: Comparison With Other Tests Based On Circulating Biomarkerssupporting

confidence: 74%

Beyond PSA: The Role of Prostate Health Index (phi)

Ferro

Cobelli

Lucarelli

et al. 2020

IJMS

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Background: Widespread use of prostate specific antigen (PSA) in screening procedures allowed early identification of an increasing number of prostate cancers (PCas), mainly including indolent cancer. Availability of different therapeutic strategies which have a very different impact on the patient's quality of life suggested a strong need for tools able to identify clinically significant cancer at diagnosis. Multi-parametric magnetic resonance showed very good performance in pre-biopsy diagnosis. However, it is an expensive tool and requires an experienced radiologist. In this context, a simple blood-based test is worth investigating. In this context, researchers focused their attention on the development of a laboratory test able to minimize overdiagnosis without losing the identification of aggressive tumors. Results: Recent literature data on PCa biomarkers revealed a clear tendency towards the use of panels of biomarkers or a combination of biomarkers and clinical variables. Phi, the 4Kscore, and Stockholm3 as circulating biomarkers and the Mi-prostate score, Exo DX Prostate, and Select MD-X as urinary biomarker-based tests have been developed. In this scenario, phi is worthy of attention as a noninvasive test significantly associated with aggressive PCa. Conclusions: Literature data showed that phi had good diagnostic performance to identify clinically significant (cs) PCa, suggesting that it could be a useful tool for personalized treatment decision-making. In this review, phi potentialities, limitations, and comparisons with other blood-and urinary-based tests were explored.

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Section: Comparison With Other Tests Based On Circulating Biomarkerssupporting

confidence: 74%

Beyond PSA: The Role of Prostate Health Index (phi)

Ferro

Cobelli

Lucarelli

et al. 2020

IJMS

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“…We acknowledge that the definition of tumor aggressiveness by pGS ≥7 is prone to criticism, but the ability of iXip resulted to be significant in terms of pAUC in the ROC curve only in the pGS > 7 cohort. These results supplement previous study results, based on prostate biopsy, which demonstrated the cutoff 0.3 for GS ≥ 7 disease (12,14).…”

Section: Discussionsupporting

confidence: 91%

“…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). The output generated by the algorithm is a numerical value ranging between 0% and 100% directly correlated with the risk of PCa at biopsy.…”

Section: Introductionmentioning

confidence: 99%

“…The output generated by the algorithm is a numerical value ranging between 0% and 100% directly correlated with the risk of PCa at biopsy. A recent paper from our group (13) reviewed the actual clinical applications of this biomarker in biopsy naïve patients (11,12,14), in men with previous negative biopsy (15), and in patients with clinically significant cancers (12,14) and during active surveillance (16). 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.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Correlation Between iXip and Final Pathology in Patients Affected by Prostate Cancer Undergoing Radical Prostatectomy: A Multicenter Prospective Trial (PROXIMA—PROstate iXip Index Multicenter Analysis)

et al. 2022

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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.

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“…Compared to PSA, serological levels of PSA-IgM have showed a better accuracy for the diagnosis of PCa [5] and have been included in an algorithm to generate the diagnostic index iXip, which determines the probability of having PCa. The algorithm processes the values of PSA and PSA-IgM, age, and prostate volume (PV) of the patient to provide the probability of that patient of having PCa [6,7]. The index was created to reduce the number of negative biopsies and to assist physicians in making a better-informed decision on whether to recommend the exam for the first time in a man suspected of having PCa.…”

Section: Introductionmentioning

confidence: 99%