Adenocarcinoma of the ProstateNCT01402154
EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients
An observational study of Adenocarcinoma of the Prostate, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- EPISPOT detection of the number of circulating cells and CellSearch detection of the number of circulating, functional, prostate cells
- How many people
- 361 participants
- Where
- 5 sitesFrance
- Study dates
- 3 Jan 2012to 15 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically proven, localized, adenocarcinoma of the prostate who accept a curative treatment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Clinique Beau Soleil
Montpellier, 34070
CHU de Montpellier - Hôpital Lapeyronie - Plateforme LCCRH
Montpellier, 34295
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque
Montpellier, 34298
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, 30029
About this study
Official title: The Pre-treatment Detection of Circulating, Functional, Prostate Cells Among Adenocarcinoma Patients: an Evaluation of the EPISPOT Technique
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
- Being tested
- EPISPOT detection of the number of circulating cells, CellSearch detection of the number of circulating, functional, prostate cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPISPOT detection of the number of circulating cellsBiological
EPISPOT detection of the number of circulating, functional, prostate cells per unit blood
CellSearch detection of the number of circulating, functional, prostate cellsBiological
CellSearch detection of the number of circulating, functional, prostate cells per unit blood
| Study group | Role | What they receive |
|---|---|---|
| All study patients | All patients included according to stated inclusion and exclusion criteria. Receives: Biological: EPISPOT detection of the number of circulating cells; Biological: CellSearch detection of the number of circulating, functional, prostate cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study start3 Jan 2012
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Droupy, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402154
- Sponsor's protocol ID
- AOI/2010/SD-01
- Other IDs
- 2011-A00328-33
- Status last verified
- Jun 2026
- First submitted
- 25 Jul 2011
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pre-treatment Detection of Circulating, Functional, Prostate Cells Among Adenocarcinoma Patients: an Evaluation of the EPISPOT Technique
- ClinicalTrials.gov ID
- NCT01402154
- Acronym / sponsor ID
- AOI/2010/SD-01
- Conditions
- Adenocarcinoma of the Prostate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 3 Jan 2012 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study patients | – | Biological: EPISPOT detection of the number of circulating cells, Biological: CellSearch detection of the number of circulating, functional, prostate cellsAll patients included according to stated inclusion and exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically proven, localized, adenocarcinoma of the prostate who accept a curative treatment.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPISPOT detection of the number of circulating cellsEPISPOT detection of the number of circulating, functional, prostate cells per unit blood | Biological | All study patients |
| CellSearch detection of the number of circulating, functional, prostate cellsCellSearch detection of the number of circulating, functional, prostate cells per unit blood | Biological | All study patients |
Primary outcome
The difference between AUCs for the EPISPOT and Cellsearch Techniques
Time frame: 1 day
The difference between the AUCs (area under the curve) for the EPISPOT and Cellsearch techniques for detecting functional, circulating prostate cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Droupy, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma of the Prostate, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between AUCs for the EPISPOT and Cellsearch Techniques (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.