STUDY OF THE EXPRESSION OF CIRCULATING AND INTRA-TUMORAL CHEMOKINES IN PATIENTS WITH PROSTATE CANCER

• Conditions: Prostate Cancer
• Interventions: Other: Blood samples; Other: Urine samples

• Registration Number: NCT02869282
• Lead Sponsor: Institut Bergonié

Brief Summary

Multicentric, observational, prospective, non-interventional study with occasional biological sample collection (serum bank, urine bank and tumor bank)

Detailed Description

This project is an exploratory study, based on the hypothesis of involvement of chemokines in hormonal escape of prostate cancers.

The two main objectives are:

* To describe the variations in expression of chemokines in serum and urine level in patients with prostate cancer

* And to study the disease stage and intra-prostatic concentrations of chemokines based on serum and urine concentrations of chemokines before treatment initiation.

These estimates can be used in future trials set up for the management of prostate cancer

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2016-06-28
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-16
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 145

Inclusion Criteria

• Patients with a localized or metastatic prostate adenocarcinoma for which a new treatment will be implemented (hormone therapy for single biological relapse or relapses and metastatic hormone-sensitive) or chemotherapy (for biological relapses and / or metastatic hormone-resistant)
• Patients with a detectable PSA (Prostate-Specific Antigen)
• Patients who signed an informed consent
• Patients over 18 years
• Patients belonging to the social security scheme

Exclusion Criteria

• Active Hepatitis B or C virus
• HIV positive
• Patients who have received prior chemotherapy
• Patients with a second neoplasia treated in the last 5 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective cohort	Urine samples	Levels of CXCL1, CCL5, CXCL8 and CXCL12 chemokines and of IL-6 cytokine by ELISA or Luminex technology.
Prospective cohort	Blood samples	Levels of CXCL1, CCL5, CXCL8 and CXCL12 chemokines and of IL-6 cytokine by ELISA or Luminex technology.

Primary Outcome Measures

Name	Time	Method
Blood urine and prostatic concentration of chemokines at baseline: CXCL1, CXCL5, CXCL8, CXCL12, cytokine IL-6. Measurement was made by Luminex or elisa technical	At baseline
Concentration of chemokines initially detectable in the blood or urine and evolution during follow-up: CXCL1, CXCL5, CXCL8, CXCL12, cytokine IL-6. Measurement was made by Luminex or elisa technical	At 24 months

Trial Locations

Locations (1)

Institut Bergonié; 🇫🇷 Bordeaux, France