Clinical trial NCT03413007: Correlation Between iXip and Final Pathology Specimen From Radical Prostatectomy: a Multicenter Prospective Trial
Official title: Correlation Between Immune compleX Predictive Index and Prostate Cancer Aggressiveness at Radical Prostetecomy Specimens: a Multicenter Prospective Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients with prostate cancer scheduled for radical prostatectomy

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/).

Eligibility criteria: 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.

Primary outcomes:
measure: correlation between iXip and significant prostate carcer
timeFrame: 6 months after surgery
Secondary outcomes:
measure: correlation between iXip and tumor volume > 0.5 cm3
timeFrame: 6 months after surgery
measure: correlation between iXip and tumor volume > 2.5 cm3
timeFrame: 6 months after surgery
measure: correlation between iXip and Gleason Score >6
timeFrame: 6 months after surgery
measure: correlation between iXip and pathological stage > pT2
timeFrame: 6 months after surgery
measure: correlation between iXip and positive lymph node at final pathology specimens
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: ASST Spedali Civili of Brescia
state: BS
Study officials:
affiliation: Spedali Civili Hospital, Brescia (Italy)
name: Alessandro Antonelli
role: PRINCIPAL_INVESTIGATOR
References: