Clinical trial · Interventional
Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer (EPIDROP)
Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Flaw in the analytical technique
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with metastatic prostate cancer
- interventionNames
- Biological: Blood sample
Primary outcomes (2)
- measure
- EPIDROP technique sensitivity versus CellSearch system sensitivity
- timeFrame
- At 18 months
- description
- Proportion of true positive and false negative patients with a confidence interval
- measure
- EPIDROP technique specificity versus CellSearch system specificity
- timeFrame
- At 18 months
- description
- Proportion of true negative and false positive healthy controls with a confidence interval
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available