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A simple blood draw could spot prostate cancer early

NCT ID NCT04556916

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study investigates whether a blood test (liquid biopsy) can detect prostate cancer early by looking for tumor cells and genetic material in the blood. Researchers will compare blood samples from men with suspected prostate cancer to those without the disease. The goal is to find a reliable, non-invasive way to identify aggressive cancers and reduce unnecessary biopsies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Blood sample analysis for circulating tumor cells, DNA, and exosomes
What this could lead to
If successful, this could lead to a simple blood test that detects prostate cancer earlier and more accurately than current methods, potentially reducing unnecessary biopsies.
What could go wrong
This is an early-stage study with 320 participants, so the test may not prove accurate enough for widespread use. The results need validation in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Sep 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Montpellier - Département d'urologie et transplantation rénale

    RECRUITING

    Montpellier, France

  • CHU Montpellier - Laboratoire des Cellules Circulantes Rares Humaines

    ACTIVE_NOT_RECRUITING

    Montpellier, France

  • CHU de Nîmes - Service Urologie Andrologie Sexologie

    RECRUITING

    Nîmes, France

  • Clinique Beau Soleil - Service d'urologie

    RECRUITING

    Montpellier, France

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