Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer (EPIDROP) (NCT04581109) | Clinical Trial Compass
TerminatedNot Applicable
Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer (EPIDROP)
Stopped: Flaw in the analytical technique
France100 participantsStarted 2021-05-27
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria :
* 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)
Exclusion Criteria:
* 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
* Inability to understand and/or respond to questionnaires
* Inability to understand the nature, purpose and methodology of the study
* Refusal to sign informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
EPIDROP technique sensitivity versus CellSearch system sensitivity
Timeframe: At 18 months
2
EPIDROP technique specificity versus CellSearch system specificity