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

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status: Unknown

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Immune compleX Predictive Index

Study type: Observational

Funder types: Other

Identifiers

NCT03413007

PSA-IgM

Details and patient eligibility

About

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.

Full 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/).

Enrollment: 300 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria are:

• histologically proven prostate cancer,
• patients scheduled for radical prostatectomy
• paziente able to provide consent
• age > 18 years or < 80 years

Exclusion criteria are:

• neiadjuvant hormone therapy
• salvage radical prostatectomy
• concomitant solid or hematological tumors,
• autoimmune disorders
• or immunosuppressive therapies,
• acute bacterial or viral infections.