Clinical trial NCT02869282: STUDY OF THE EXPRESSION OF CIRCULATING AND INTRA-TUMORAL CHEMOKINES IN PATIENTS WITH PROSTATE CANCER
Official title: TUDY OF THE EXPRESSION OF CIRCULATING AND INTRA-TUMORAL
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 145
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a localized or metastatic prostate adenocarcinoma

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At baseline
measure: 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
timeFrame: At 6 months
measure: 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
timeFrame: At 12 months
measure: 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
timeFrame: At 18 months
measure: 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
timeFrame: At 24 months
measure: Blood urine and prostatic concentration of chemokines at baseline: CXCL1, CXCL5, CXCL8, CXCL12, cytokine IL-6. Measurement was made by Luminex or elisa technical
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
Study officials:
References: