Prostate CancerEPIDROPNCT04581109
Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer (EPIDROP)
A study testing Blood sample in people with Prostate Cancer, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
The use of liquid biopsy could be the key for precision medicine. Circulating tumor cells (CTCs) are the most studied circulating biomarkers used to assess the metastatic process and they have shown their clinical validity and utility in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 27 May 2021to 12 Jun 2026
- Phase
- Interventional
- 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
Who may be able to join
- To be male, over 18 years old
- Metastatic prostate cancer naive to any treatment or metastatic prostate cancer in biological recurrence (PSA increase) and/or clinical recurrence after hormone suppression (mCRPC)
Who cannot join
- Non-metastatic prostate cancer in biological and/or clinical recurrence after hormone-suppression (nmCRPC)
- Other active or treated cancer less than 5 years old
- Be protected by law (guardianship or curatorship)
- Be deprived of liberty by administrative decision
- Not being affiliated to a social security scheme, or not being a beneficiary of such a plan
- Being in a period of exclusion from another protocol
Show all 9Show fewer
- Inability to understand and/or respond to questionnaires
- Inability to understand the nature, purpose and methodology of the study
- Refusal to sign informed consent
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital Center
Montpellier, Occitanie, 34295
University Center, Hospital
Nîmes
About this study
Official title: Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer
The use of liquid biopsy could be the key for precision medicine. Circulating tumor cells (CTCs) are the most studied circulating biomarkers used to assess the metastatic process and they have shown their clinical validity and utility in cancer patients. However, their detection and capture are still a challenge as they are very rare in the bloodstream. In this clinical trial named "EPIDROP", the investigators will use an innovative device called EPIDROP (for EPIspot in a DROP) in metastatic prostate cancer. EPIDROP is a completely new technology answering to biological and clinical questions by proposing a procedure detecting the functional subset of prostatic CTCs at the single cell level. The investigators will stain cells in the sample for EpCAM, PSMA, CD45 before to encapsulate them one by one in microdroplets and measure the PSA secretion by only the viable CTCs. This study aims to demonstrate the non-inferiority of the EPIDROP compared to the CellSearch system.
Read the detailed description
Methods :
One hundred patients with a metastatic prostate cancer will be recruited plus 50 healthy donors. Twenty ml of blood will be drawn : 10 ml of blood will be drawn on CellSave tubes (fixed cells) for CTC detection using the FDA-cleared CellSearch system (gold standard) and 10 ml of blood will be drawn on EDTA tubes (viable cells) for the detection of functional CTCs using the EPIDROP. Patients will be followed for 18 months.
Samples from fifty control subjects will be provided by the Etablissement Français du Sang.
- Conditions
- Prostate Cancer
- Being tested
- Blood sample
- Keywords
- Circulating tumor cells (CTCs), Biomarker, CellSearch, EPIDROP
- Medical subject headings
- Prostatic Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Twenty ml of blood will be drawn from each patient : 10 ml of blood will be drawn on CellSave tubes (fixed cells) for CTC detection using the FDA-cleared CellSearch system (gold standard) and 10 ml of blood will be drawn on EDTA tubes (viable cells) for the detection of functional CTCs using the EPIDROP.
| Study group | Role | What they receive |
|---|---|---|
| Patients with metastatic prostate cancer | Experimental | Not described Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPIDROP technique sensitivity versus CellSearch system sensitivity
Proportion of true positive and false negative patients with a confidence interval
Measured: At 18 months
EPIDROP technique specificity versus CellSearch system specificity
Proportion of true negative and false positive healthy controls with a confidence interval
Measured: At 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start27 May 2021
- Primary completion12 May 2025
- Study completion12 Jun 2026
Why it stopped: Flaw in the analytical technique
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581109
- Sponsor's protocol ID
- RECHMPL17_0318
- Other IDs
- 2018-A03249-46
- Acronym
- EPIDROP
- Status last verified
- May 2026
- First submitted
- 2 Oct 2020
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT04581109
- Acronym / sponsor ID
- EPIDROP / RECHMPL17_0318
- Conditions
- Prostate Cancer
- Keywords
- Circulating tumor cells (CTCs), Biomarker, CellSearch, EPIDROP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Flaw in the analytical technique
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 9 Oct 2020 (actual)
- 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 use of liquid biopsy could be the key for precision medicine. Circulating tumor cells (CTCs) are the most studied circulating biomarkers used to assess the metastatic process and they have shown their clinical validity and utility in cancer patients. However, their detection and capture are still a challenge as they are very rare in the bloodstream. In this clinical trial named "EPIDROP", the investigators will use an innovative device called EPIDROP (for EPIspot in a DROP) in metastatic prostate cancer. EPIDROP is a completely new technology answering to biological and clinical questions by proposing a procedure detecting the functional subset of prostatic CTCs at the single cell level. The investigators will stain cells in the sample for EpCAM, PSMA, CD45 before to encapsulate them one by one in microdroplets and measure the PSA secretion by only the viable CTCs. This study aims to demonstrate the non-inferiority of the EPIDROP compared to the CellSearch system.
Detailed description
Methods :
One hundred patients with a metastatic prostate cancer will be recruited plus 50 healthy donors. Twenty ml of blood will be drawn : 10 ml of blood will be drawn on CellSave tubes (fixed cells) for CTC detection using the FDA-cleared CellSearch system (gold standard) and 10 ml of blood will be drawn on EDTA tubes (viable cells) for the detection of functional CTCs using the EPIDROP. Patients will be followed for 18 months.
Samples from fifty control subjects will be provided by the Etablissement Français du Sang.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with metastatic prostate cancer | Experimental | Biological: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To be male, over 18 years old
- Metastatic prostate cancer naive to any treatment or metastatic prostate cancer in biological recurrence (PSA increase) and/or clinical recurrence after hormone suppression (mCRPC)
Key exclusion criteria (9 listed)
- Non-metastatic prostate cancer in biological and/or clinical recurrence after hormone-suppression (nmCRPC)
- Other active or treated cancer less than 5 years old
- Be protected by law (guardianship or curatorship)
- Be deprived of liberty by administrative decision
- Not being affiliated to a social security scheme, or not being a beneficiary of such a plan
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 |
|---|---|---|
| Blood sampleTwenty ml of blood will be drawn from each patient : 10 ml of blood will be drawn on CellSave tubes (fixed cells) for CTC detection using the FDA-cleared CellSearch system (gold standard) and 10 ml of blood will be drawn on EDTA tubes (viable cells) for the detection of functional CTCs using the EPIDROP. | Biological | Patients with metastatic prostate cancer |
Primary outcome
EPIDROP technique sensitivity versus CellSearch system sensitivity
Time frame: At 18 months
Proportion of true positive and false negative patients with a confidence interval
EPIDROP technique specificity versus CellSearch system specificity
Time frame: At 18 months
Proportion of true negative and false positive healthy controls with a confidence interval
Results and safety
The study was stopped early (reason given: Flaw in the analytical technique). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Prostate Cancer, run by University Hospital, Montpellier at 2 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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 22 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 2 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 was stopped early (reason given: Flaw in the analytical technique). Results are not available in the source record.
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?
EPIDROP technique sensitivity versus CellSearch system sensitivity (time frame: At 18 months). The study lists 2 primary outcomes in all. 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 22 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.