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

NCT04581109 | Recruiting

• 2 other identifiers: RECHMPL17_03182018-A03249-46
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer

Keywords

Circulating tumor cells (CTCs); Biomarker; CellSearch; EPIDROP

Outcome Measures

Primary Outcomes (2)

• EPIDROP technique sensitivity versus CellSearch system sensitivity

  Proportion of true positive and false negative patients with a confidence interval

  At 18 months

• EPIDROP technique specificity versus CellSearch system specificity

  Proportion of true negative and false positive healthy controls with a confidence interval

  At 18 months

Study Arms (1)

Patients with metastatic prostate cancer

EXPERIMENTAL

Biological: Blood sample

Interventions

Blood sample BIOLOGICAL

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.

Patients with metastatic prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Inability to understand and/or respond to questionnaires
• Inability to understand the nature, purpose and methodology of the study
• Refusal to sign informed consent

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

University Hospital Center

Montpellier, Occitanie, 34295, France

ACTIVE NOT RECRUITING

University Center, Hospital

Nîmes, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Catherine ALIX-PANABIERES, MCU-PH

CONTACT

04 11 75 99 31; c-panabieres@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 9, 2020
• Study Start: May 27, 2021
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)