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

Study Overview
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Brief Summary
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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
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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/).

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Immune compleX Predictive Index


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between iXip and significant prostate carcer | correlation between iXip and significant prostate carcer at final pathology specimens, defined as tumor volume > 0.5 cm3 and Gleason scor equal or superior to 7. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features. | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between iXip and tumor volume > 0.5 cm3 | clinical and pathological correlation between iXip values and tumour volume at final pathology specimens. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features ( >0.5cm3 tumor volume ) | 6 months after surgery | 
| correlation between iXip and tumor volume > 2.5 cm3 | clinical and pathological correlation between iXip values and tumour volume at final pathology specimens. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features ( >2.5cm3 tumor volume ). | 6 months after surgery | 
| correlation between iXip and Gleason Score >6 | clinical and pathological correlation between iXip values and tumour volume at final pathology specimens. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features ( Gleason Score> 6) | 6 months after surgery | 
| correlation between iXip and pathological stage > pT2 | clinical and pathological correlation between iXip values and tumour volume at final pathology specimens. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features ( pathological staging >pT2) | 6 months after surgery | 
| correlation between iXip and positive lymph node at final pathology specimens | clinical and pathological correlation between iXip values and tumour volume at final pathology specimens. iXip values are expressed as a percentage and vary from 0% to 100%. Higher iXip values (>30%) should be associated with aggressive pathological features ( positive lymph nodes >0) | 6 months after surgery |