Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer (EPIDROP)

  • STATUS
    Recruiting
  • End date
    Oct 9, 2023
  • participants needed
    100
  • sponsor
    University Hospital, Montpellier
Updated on 9 June 2021

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.

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 Franais du Sang.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, prostate carcinoma, prostate cancers
Treatment Blood sample
Clinical Study IdentifierNCT04581109
SponsorUniversity Hospital, Montpellier
Last Modified on9 June 2021

Eligibility

Yes No Not Sure

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
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