EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients

NCT01402154 | Completed

• 2 other identifiers: AOI/2010/SD-012011-A00328-33
• Study Type: observational
• Target: 361
• Locations: 1 country
• Sites: 5

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.

Conditions

Adenocarcinoma of the Prostate

Outcome Measures

Primary Outcomes (1)

• The difference between AUCs for the EPISPOT and Cellsearch Techniques

  The difference between the AUCs (area under the curve) for the EPISPOT and Cellsearch techniques for detecting functional, circulating prostate cells

  1 day

Study Arms (1)

All study patients

All patients included according to stated inclusion and exclusion criteria.

Biological: EPISPOT detection of the number of circulating cells; Biological: CellSearch detection of the number of circulating, functional, prostate cells

Interventions

EPISPOT detection of the number of circulating cells BIOLOGICAL

EPISPOT detection of the number of circulating, functional, prostate cells per unit blood

All study patients

CellSearch detection of the number of circulating, functional, prostate cells BIOLOGICAL

CellSearch detection of the number of circulating, functional, prostate cells per unit blood

All study patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically proven, localized, adenocarcinoma of the prostate who accept a curative treatment.

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (5)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

Clinique Beau Soleil

Montpellier, 34070, France

Location

CHU de Montpellier - Hôpital Lapeyronie - Plateforme LCCRH

Montpellier, 34295, France

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque

Montpellier, 34298, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Following the completion of the biological analyses required for this study, leftover tubes may be placed in the Nîmes University Hospital biological collection for future ancillary studies, if patients are agreed with this. The samples concerned include EDTA and CellSave tubes for each patient.

MeSH Terms

Interventions

Functional Status

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Stéphane Droupy, MD PhD

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: January 3, 2012
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

FR (5)