EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients

• Conditions: Adenocarcinoma of the Prostate
• Interventions: Biological: EPISPOT detection of the number of circulating cells; Biological: CellSearch detection of the number of circulating, functional, prostate cells

• 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

Arm && Interventions

Group	Intervention	Description
All study patients	CellSearch detection of the number of circulating, functional, prostate cells	All patients included according to stated inclusion and exclusion criteria.
All study patients	EPISPOT detection of the number of circulating cells	All patients included according to stated inclusion and exclusion criteria.

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; 🇫🇷 Montpellier Cedex 05, France

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

Clinique Beau Soleil; 🇫🇷 Montpellier, France

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