Studio di validazione dell’IxipPlus, un nuovo marker per la neoplasia prostatica e sua valutazione comparativa con gli altri marker attualmente disponibili

Study on the validity of iXip Plus, a new prostate neoplasm marker and its comparative assessment in relation to the other cancer markers currently available. Arancio Marcello Introduction: at the present time, no cancer marker allows to arrive at a definite diagnosis of prostate cancer (PCa) or to determine the aggressiveness of cancer in the diagnostic phase. Materials and methods: 365 blood samples of patients who were candidates for prostate biopsy were collected and a new prostate cancer marker, PSA IgM, was measured. Of those patients, 114 also provided urine samples, from which the following prostate cancer marker levels were measured: tPSA, fPSA, f/t PSA, p2PSA, Phy, PCA3 score, PSA IgM and iXip Plus. These patients were also evaluated by means of transrectal ultrasound and biopsy. Results: PSA IgM level was correlated with the patient age and prostate volume and iXip, a PCa prediction rate, was calculated. iXip was subsequently correlated with PSA in order to obtain iXip Plus, which makes it possible to subdivide the population in two groups: the first one being that of patients at high risk and the other of those at low risk for PCa. This leads to a reduction in the number of unnecessary biopsies. The various prostate cancer markers were analyzed in several possible combinations and through univariate analysis and simultaneous analysis of f/t PSA, iXip Plus, PCA3 score and Phi, which demonstrated that 70% of the patients could be correctly classified prior to performing biopsy. By only using f/t PSA and iXip Plus prediction rate, 68% of the cases can be correctly classified. Through multivariate analysis, by considering tPSA, patient age and rectal exam together, 76% of the patients can be correctly classified, while PCA3 score and iXip Plus lose their relevance. Conclusions: the results of this study support the current guidelines on PCa diagnosis, which recommend tPSA, f/t PSA and rectal exam as first level screening tests to determine if patients are candidates for prostate biopsy in the presence of a clinical suspicion of PCa. PCA3 score does not seem to be an accurate indicator of PCa in patients who already had a first set of biopsies taken. No marker can predict the degree of PCa aggressiveness in the diagnostic phase.