An observational study in Prostate Cancer, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Status unknown at 1 site in Italy. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-07-19.
Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Observational
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.
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/).
Male patients with prostate cancer scheduled for radical prostatectomy
Exclusion criteria are:
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
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.
Time frame: 6 months after surgery
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 )
Time frame: 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 ).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months after surgery
Plan to share: Undecided
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia