Overview

This trial is active, not recruiting.

Condition adenocarcinoma of the prostate
Treatments epispot detection of the number of circulating cells, cellsearch detection of the number of circulating, functional, prostate cells
Sponsor Centre Hospitalier Universitaire de Nīmes
Start date January 2012
End date December 2017
Trial size 361 participants
Trial identifier NCT01402154, 2011-A00328-33, AOI/2010/SD-01

Summary

The primary objective of this study is to evaluate the predictive value (in terms of remission) of a new technique for detecting circulating, functional, prostate cells among patients with localized adenocarcinoma of the prostate, and prior to any treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
All patients included according to stated inclusion and exclusion criteria.
epispot detection of the number of circulating cells
EPISPOT detection of the number of circulating, functional, prostate cells per unit blood
cellsearch detection of the number of circulating, functional, prostate cells
CellSearch detection of the number of circulating, functional, prostate cells per unit blood

Primary Outcomes

Measure
The difference between AUCs for the EPISPOT and Cellsearch Techniques
time frame: 1 day

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - The patient must have given his/her informed and signed consent - The patient must be insured or beneficiary of a health insurance plan - Histologically proven presence of prostate adenocarcinoma - Localized disease on digital rectal examination - Cancer without extensions - Acceptance of a curative treatment by the patient Exclusion Criteria: - The patient is participating in another study - The patient is in an exclusion period determined by a previous study - The patient is under judicial protection, under tutorship or curatorship - The patient refuses to sign the consent - It is impossible to correctly inform the patient - The patient is taking a hormone-modifying treatment - Patient taking adrogenic supplements

Additional Information

Official title The Pre-treatment Detection of Circulating, Functional, Prostate Cells Among Adenocarcinoma Patients: an Evaluation of the EPISPOT Technique
Principal investigator Stéphane Droupy, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes.