A simple blood draw could spot prostate cancer early
NCT ID NCT04556916
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
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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
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About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Sep 2033
An estimate. End dates often move.
- Lead sponsor
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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
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40 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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CHU Montpellier - Département d'urologie et transplantation rénale
RECRUITINGMontpellier, France
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CHU Montpellier - Laboratoire des Cellules Circulantes Rares Humaines
ACTIVE_NOT_RECRUITINGMontpellier, France
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CHU de Nîmes - Service Urologie Andrologie Sexologie
RECRUITINGNîmes, France
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Clinique Beau Soleil - Service d'urologie
RECRUITINGMontpellier, France
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Other studies related to the condition(s) this trial covers.
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- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains