Detect viable circulating prostate cancer cells with EPIDROP
Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer
This test will try to see if the EPIDROP device can detect live circulating tumor cells in men with metastatic prostate cancer and how its results compare to the standard CellSearch test.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 2 sites (Montpellier, Occitanie and 1 other locations) |
| Trial ID | NCT04581109 on ClinicalTrials.gov |
What this trial studies
EPIDROP is a novel microdroplet platform that stains and isolates single circulating tumor cells (CTCs) from blood to measure PSA secretion from viable prostate CTCs. In this study, 100 men with metastatic prostate cancer and 50 healthy donors will each provide 20 mL of blood split between CellSearch (fixed cells) and EPIDROP (viable cells) samples. Cells will be labeled for EpCAM, PSMA and CD45, encapsulated singly in microdroplets, and monitored for PSA release to identify functional CTCs. Patients will be followed for 18 months to compare EPIDROP's detection performance to the FDA-cleared CellSearch system.
Who should consider this trial
Good fit: Men aged 18 or older with metastatic prostate cancer who are treatment-naive or who have biochemical or clinical recurrence after hormone suppression are eligible.
Not a fit: Men with non-metastatic prostate cancer, recent other cancers within five years, those under legal protection, or unable/unwilling to consent are unlikely to benefit from joining.
Why it matters
Potential benefit: If successful, EPIDROP could provide more specific detection of live, PSA-secreting prostate CTCs to help personalize monitoring and treatment decisions.
How similar studies have performed: The CellSearch system is an established FDA-cleared method for CTC enumeration, but EPIDROP's single-cell viability and PSA-secretion measurements represent a novel approach with limited prior clinical validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montpellier, Occitanie and 1 other locations
- University Hospital Center — Montpellier, Occitanie, France (Active_not_recruiting)
- University Center, Hospital — Nîmes, France (Recruiting)
Study contacts
- Study coordinator: Catherine ALIX-PANABIERES, MCU-PH
- Email: c-panabieres@chu-montpellier.fr
- Phone: 04 11 75 99 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.