Clinical trial Recruiting at 3 sites Interventional Ages 40 and up Men only

Detecting prostate cancer early using blood tests

Official title: Early Detection of Prostate Cancer by Liquid Biopsy

Run by University Hospital, Montpellier · NCT04556916 · Data updated 2026-11-12

This study is testing whether blood tests can help find prostate cancer earlier in patients who might have it by looking for specific markers in their blood.

Quick facts

Study typeInterventional
Ages40 Years and up
SexMen only
Enrollment320 (estimated)
SponsorUniversity Hospital, Montpellier
Academic / other
Locations4 sites (Montpellier and 3 other locations)
StatusRecruiting
StartedFebruary 19, 2021
Main results expectedNovember 15, 2023
Study endsSeptember 15, 2033
Registry record updatedJune 22, 2026
Trial IDNCT04556916 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men over 40 who are suspected of having prostate cancer and are scheduled for a biopsy.

Probably not a fit

Patients with histologically confirmed prostate cancer or those undergoing certain treatments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on the early detection of prostate cancer by analyzing circulating blood-based biomarkers, specifically circulating tumor cells (CTCs) and tumor cell products. Patients suspected of having prostate cancer will provide blood samples before undergoing a biopsy, allowing researchers to assess which liquid biopsy markers can best differentiate between those with prostate cancer and age-matched controls. The study aims to identify high-risk patients with aggressive tumors and validate the effectiveness of these biomarkers compared to current standard detection methods.

Why it matters

Potential benefit: If successful, this study could lead to a more accurate and less invasive method for early detection of prostate cancer.

How similar studies have gone: Other studies have shown promise in using liquid biopsies for cancer detection, but this specific approach is still being validated.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria Patient :

* Men over 40 being suspicious of prostate cancer
* Subject with PSA ≥ 4 and designated for biopsy
* Subjects must be able to attend all scheduled visits and to comply with all trial procedures
* mpMRI done before prostate biopsy
* Subject must be covered by public health insurance
* Signed informed consent form

Inclusion Criteria Subject Control Patient patient free from prostatic disease :

* Men over 40 with no suspicion of prostate cancer
* Subject with PSA \< 2.5 and normal digital rectal examination
* Subject must be covered by public health insurance
* Signed informed consent form

Exclusion Criteria Patient :

* Subject with histologically confirmed prostate cancer
* Subject with a verified viral infection (HIV or Hepatitis)
* Subject under Finasteride treatment
* Subject under hormonal treatment (analogs, antagonists, androgenics)
* Subject with other cancer diagnosed
* Subject unable to sign consent
* Planned longer stay outside the region that prevents compliance with the visit plan
* Subject deprived of liberty, protected adults or vulnerable persons
* Urinary infection ≤ 2 months
* Subject excluding health insurance registration
* Subject refusing to perform prostate biopsy
* Subject who are in a dependency or employment with the sponsor or the investigator

Exclusion Criteria Subject Control :

* Subject with histologically confirmed prostate cancer
* Subject with a verified viral infection (HIV or Hepatitis)
* Subject under Finasteride treatment
* Subject with other cancer diagnosed
* Subject unable to sign consent
* Planned longer stay outside the region that prevents compliance with the visit plan
* Subject deprived of liberty, protected adults or vulnerable persons
* Urinary infection ≤ 2 months
* Subject excluding health insurance registration

Where it's running

  • CHU Montpellier - Département d'urologie et transplantation rénale
    Montpellier, France
    Recruiting
  • Clinique Beau Soleil - Service d'urologie
    Montpellier, France
    Recruiting
  • CHU de Nîmes - Service Urologie Andrologie Sexologie
    Nîmes, France
    Recruiting
  • CHU Montpellier - Laboratoire des Cellules Circulantes Rares Humaines
    Montpellier, France
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.