Prostate Cancer
Conditions
Brief 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/).
Interventions
DIAGNOSTIC_TESTImmune 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
Sponsors
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| correlation between iXip and significant prostate carcer | 6 months after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| correlation between iXip and tumor volume > 0.5 cm3 | 6 months after surgery | 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 ) |
| correlation between iXip and tumor volume > 2.5 cm3 | 6 months after surgery | 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 ). |
| correlation between iXip and Gleason Score >6 | 6 months after surgery | 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) |
| correlation between iXip and pathological stage > pT2 | 6 months after surgery | 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) |
| correlation between iXip and positive lymph node at final pathology specimens | 6 months after surgery | 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) |
Countries
Italy
Contacts
Primary ContactAlessandro Antonelli
Outcome results
None listed