Prostate Cancer Clinical Trial
Official title:
Correlation Between Immune compleX Predictive Index and Prostate Cancer Aggressiveness at Radical Prostetecomy Specimens: a Multicenter Prospective Trial
NCT number | NCT03413007 |
Other study ID # | PSA-IgM |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 9, 2018 |
Est. completion date | December 2018 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | ASST Spedali Civili of Brescia | Brescia | BS |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Spedali Civili di Brescia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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