NCT03413007

Correlation Between iXip and Final Pathology Specimen From Radical Prostatectomy: a Multicenter Prospective Trial

Correlation Between Immune compleX Predictive Index and Prostate Cancer Aggressiveness at Radical Prostetecomy Specimens: a Multicenter Prospective Trial

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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/).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Immune compleX Predictive Index	iXip is an algorithm thant integrates PSA, PSA-IgM, prostate volume and age of the patient in order to provide the probability of prostate cancer

Timeline

• Start date: 2018-02-09
• Primary completion: 2018-10-01
• Completion: 2018-12-01
• First posted: 2018-01-29
• Last updated: 2018-07-19

Locations

1 site across 1 country: Italy