EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients

• Conditions: Adenocarcinoma of the Prostate

• Registration Number: NCT01402154
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Study Start: 2012-01-03
• Primary Completion: 2014-12-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 361

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference between AUCs for the EPISPOT and Cellsearch Techniques	1 day	The difference between the AUCs (area under the curve) for the EPISPOT and Cellsearch techniques for detecting functional, circulating prostate cells

Trial Locations

Locations (5)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, Gard, France

CHU de Montpellier - Hôpital Lapeyronie - Plateforme LCCRH; 🇫🇷 Montpellier Cedex 05, France

CHU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier Cedex 05, France

Clinique Beau Soleil; 🇫🇷 Montpellier, France

Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque; 🇫🇷 Montpellier, France