Correlation Between iXip and Final Pathology Specimen From Radical Prostatectomy: a Multicenter Prospective Trial

NCT03413007 | Unknown

• 1 other identifier: PSA-IgM
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• correlation between iXip and tumor volume > 0.5 cm3

  6 months after surgery

• correlation between iXip and tumor volume > 2.5 cm3

  6 months after surgery

• correlation between iXip and Gleason Score >6

  6 months after surgery

• correlation between iXip and pathological stage > pT2

  6 months after surgery

• correlation between iXip and positive lymph node at final pathology specimens

  6 months after surgery

Interventions

Immune compleX Predictive Index DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients with prostate cancer scheduled for radical prostatectomy

You may qualify if:

• histologically proven prostate cancer,
• patients scheduled for radical prostatectomy
• paziente able to provide consent
• age \> 18 years or \< 80 years

You may not qualify if:

• neiadjuvant hormone therapy
• salvage radical prostatectomy
• concomitant solid or hematological tumors,
• autoimmune disorders
• or immunosuppressive therapies,
• acute bacterial or viral infections.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

ASST Spedali Civili of Brescia

Brescia, BS, 25123, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

a blood serum sample will be stored for each patient

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alessandro Antonelli

  Spedali Civili Hospital, Brescia (Italy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Antonelli

CONTACT

+390303995215; alessandro_antonelli@me.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology consultant

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 29, 2018
• Study Start: February 9, 2018
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

IT (1)