The role of immune PSA complex (iXip) in the prediction of prostate cancer

Riccardo Lombardo,Giorgia Tema,Fabiana Cancrini,Luca Albanesi,Luca Mavilla,Paola Tariciotti,Barbara Cristina Gentile,Pietro Aloisi,Giorgio Rizzo,Stefano Tardioli,Roberto Giulianelli

doi:10.1080/1354750x.2020.1841294

Abstract

Purpose To analyse the performance of iXip in the prediction of prostate cancer (PCa) and high-grade PCa. Methods A consecutive series of men undergoing MRI/FUSION prostate biopsies were enrolled in one centre. Indications for prostate biopsy included abnormal prostate-specific antigen (PSA) levels (PSA > 4 ng/ml) and/or abnormal digital rectal examination (DRE) and/or abnormal MRI. All patients underwent the evaluation of serum PSA-IgM concentration and the iXip ratio was calculated. Accuracy iXip for the prediction of PCa was evaluated using multivariable binary regression analysis and receiver operator characteristics (ROC) curves. Results Overall 160 patients with a median age of 65 (62/73) years were enrolled. Overall, 42% patients were diagnosed with PCa and 75% of them had high-grade cancer (Epstein ≥ 3). Patients with PCa were older and presented higher PSA levels, higher PIRADS scores and lower prostate volumes (PVs). On ROC analysis iXip presented an area under the curve (AUC) of 0.57 in the prediction of PCa and of 0.54 for the prediction of high-grade PCa. Conclusions In our experience, immune PSA complexes are not predictors of PCa. iXip analysis should not be included in the diagnostic pathway of patients at increased risk of PCa.

Highlights

Prostate cancer (PCa) is the second most frequently diagnosed cancer and the sixth leading cause of cancer death among men
Prostate biopsies are associated with a small a risk of morbidity in addition to being M costly and uncomfortable for patients[5,6] d In the past years, several authors have focused on the development of PCa molecular te biomarkers, like prostate cancer antigen 3 (PCA3) or circulating tumour cells (CTs) to p improve the abovementioned limitations of Prostate specific antigen (PSA) 7
The iXip is automatic an algorithm including age, prostate volume, PSA, and PSA-IgM levels developed by Xeptagen to predict PCa risk, very few studies have validated its clinical use

Summary

INTRODUCTION

Prostate cancer (PCa) is the second most frequently diagnosed cancer and the sixth leading cause of cancer death among men. Several patients will undergo unnecessary u prostate biopsies, in the PSA range of 4.0–10.0 ng/ml, where prostate n cancer is present in only 25% of men 4. Prostate biopsies are associated with a small a risk of morbidity ( infections, acute urinary retention, bleeding) in addition to being M costly and uncomfortable for patients[5,6] d In the past years, several authors have focused on the development of PCa molecular te biomarkers, like prostate cancer antigen 3 (PCA3) or circulating tumour cells (CTs) to p improve the abovementioned limitations of PSA 7. The iXip is automatic an algorithm including age, prostate volume, PSA, and PSA-IgM levels developed by Xeptagen to predict PCa risk, very few studies have validated its clinical use. Aim of our study was to evaluate the role of iXip in prostate cancer diagnosis in a cohort of patients undergoing MRI/FUSION prostate biopsies

MATERIALS AND METHODS

RESULTS

High-grade cancer evaluation

Conflict of Interest: