RecruitingNot ApplicableNCT04581109

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

Sponsor

University Hospital, Montpellier

Enrollment

100 participants

Start Date

May 27, 2021

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests new technology called EPIDROP to detect and analyze live circulating tumor cells (CTCs) in the blood of men with metastatic prostate cancer. CTCs are cancer cells that have broken away from a tumor and entered the bloodstream. Detecting them could help doctors better track cancer and guide treatment decisions. **You may be eligible if...** - You are male and 18 years or older - You have metastatic prostate cancer, either newly diagnosed (treatment-naive) or with rising PSA and/or clinical signs of progression after hormone therapy (mCRPC) **You may NOT be eligible if...** - You have non-metastatic prostate cancer - You have had another active or treated cancer within the past 5 years - You are under legal guardianship or have restricted liberty by administrative decision - You are not affiliated with a social security scheme - You are currently excluded from another research protocol - You cannot understand the study or provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBlood sample

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.

Locations(2)

University Hospital Center

Montpellier, Occitanie, France

University Center, Hospital

Nîmes, France

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NCT04581109

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