Correlation Between iXip and Final Pathology Specimen From Radical Prostatectomy: a Multicenter Prospective Trial
- Conditions
- Prostate Cancer
- Registration Number
- NCT03413007
- 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/).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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)
Trial Locations
- Locations (1)
ASST Spedali Civili of Brescia
🇮🇹Brescia, BS, Italy