Prostate Cancer Clinical Trial
Official title:
Correlation Between Immune compleX Predictive Index and Prostate Cancer Aggressiveness at Radical Prostetecomy Specimens: a Multicenter Prospective Trial
The Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa) diagnosis that integrates PSA, PSA-IgM, prostate volume and age of the patient. An algorithm processes these parameters providing the probability of prostate cancer. Several prospective studies confirmed its ability to predict prostate cancer presence at biopsy and therefore to reduce the rate of useless prostate biopsies. Moreover, preliminary results from a prospective study showed that iXip could predict cancer aggressiveness, too.
Since the 90s, serum PSA has become the cornerstone of diagnosis of PCa, However, due to its
proven poor specificity, the actual role of PSA testing has been largely debated, especially
if used during opportunistic screening programs. leading to a significant risk of
over-diagnosis and over treatment.
In order to overcome drawbacks of PSA-based diagnostic pathway several PSA-derivates has been
proposed. However, they were marginally used in clinical practice because not supplied by
public health care systems.
The Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa)
diagnosis that integrates PSA, PSA-IgM, prostate volume and age of the patient. An algorithm
processes these parameters providing the probability of prostate cancer. Several prospective
studies confirmed its ability to predict prostate cancer presence at biopsy and therefore to
reduce the rate of useless prostate biopsies. Moreover, preliminary results from a
prospective study showed that iXip could predict cancer aggressiveness, too.
All pathological specimens are analyzed by an expert uropathologist, following ISUP
reccomandations.
Before radical prostectomy a blood sample from each patients is collected. Serum PSA-IgM
concentration is measured using Prostate-IC kit in duplicate. The analysis with Prostate-IC
kit was performed on automated ELISA analyzer.Then the iXip index is calculated by using the
online calculator (http://ixip.xeptagen.com/).
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