NCT02869282

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

5.5 years

First QC Date

June 28, 2016

Last Update Submit

September 12, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 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 6 months

Study Arms (1)

Prospective cohort

Levels of CXCL1, CCL5, CXCL8 and CXCL12 chemokines and of IL-6 cytokine by ELISA or Luminex technology.

Other: Blood samplesOther: Urine samples

Interventions

Additional blood samples at baseline, 6, 12, 18 and 24 months.

Prospective cohort

Additional urine samples at baseline, 6, 12, 18 and 24 months.

Prospective cohort

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a localized or metastatic prostate adenocarcinoma

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Bergonié

Bordeaux, 33076, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Additional blood and urine samples (8 ml blood and 20 ml urine tubes)

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

August 16, 2016

Study Start

June 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations