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Blood Test Study for Early Detection of Prostate Cancer

Tests blood markers to find prostate cancer early in men aged 40 and older.

Key facts

Who runs it
University Hospital, Montpellier
Where
Montpellier and Nîmes, FranceSee the 4 sites
Trial code
Registry title
Early Detection of Prostate Cancer
Status
Recruiting
People taking part
320 people, planned
Started
19 Feb 2021
Expected to end
15 Sept 2033
Type of study
Interventional, 2 groups
Treatments tested
  • Blood sample
Record updated
22 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men over 40. One group is men suspected of prostate cancer who will have a prostate biopsy. The other group is men with no prostate disease.

Age
40 years or older
Sex
Men only
Disease stage
Suspected prostate cancer, not yet confirmed. The comparison group has no suspicion of prostate cancer.
Earlier treatment
Cannot be on Finasteride. Patients suspected of prostate cancer also cannot be on hormonal treatment (analogs, antagonists, androgenics).
Biomarker or test result
Patients: PSA of 4 or higher. Comparison group: PSA below 2.5 and a normal digital rectal examination.

Main reasons for not taking part

  • Prostate cancer already confirmed by biopsy
  • HIV or hepatitis infection
  • Another cancer diagnosed
  • Urinary infection within the last 2 months
  • Refusing a prostate biopsy (patient group)

The registry criteria, word for word

Show all 31 criteriaShow less

Who can take part

  • 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
  • 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

Who cannot take part

  • Subject with histologically confirmed prostate cancer
  • Subject with a verified viral infection (HIV or Hepatitis)
  • Subject with other cancer diagnosed
  • Urinary infection ≤ 2 months
  • Subject with histologically confirmed prostate cancer
  • Subject with a verified viral infection (HIV or Hepatitis)
  • Subject with other cancer diagnosed
  • Urinary infection ≤ 2 months
  • Subject under Finasteride treatment
  • Subject under hormonal treatment (analogs, antagonists, androgenics)
  • 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
  • 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
  • Subject under Finasteride treatment
  • 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
  • Subject excluding health insurance registration

Where in France

  • CHU Montpellier - Département d'urologie et transplantation rénaleMontpellier, FranceContact: Rodolphe THURET, PU-PHTaking people
  • Clinique Beau Soleil - Service d'urologieMontpellier, FranceContact: Xavier REBILLARD, MD-PhDTaking people
  • CHU Montpellier - Laboratoire des Cellules Circulantes Rares HumainesMontpellier, FranceContact: Catherine ALIX-PANABIERES, MCU-PHNo longer taking part
  • CHU de Nîmes - Service Urologie Andrologie SexologieNîmes, FranceContact: Stéphane DROUPY, MD-PhDTaking people

About the trial

What the trial wants to find out

This study is the early detection of prostate cancer by analysing circulating bloodbased biomarkers. Based on our latest developments, we primarily aim to assess the validity of CTCs (circulating tumour cells) and tumour cell products circulating in blood (DNA, exosomes) for early PCa (Prostate cancer) detection.

Read full original descriptionShow less

In the first discovery period, the investigators will assess which Liquid biopsy marker will provide the best discrimination between the patients with histologically proven PCa and age-matched noncancer controls. Further subset analysis with special emphasis on the identification of high risk PCa patients with aggressive tumours as defined by a Gleason score ("gold standard") of 8 or higher (ISUP 4 and higher), will be performed. The resulting biomarker candidates will then be further explored in the subsequent training and validation study (years 2 and 3) in order to obtain the single blood test or combination of tests with the highest sensitivity and specificity for detection of early PCa and/or high-risk PCa. The investigators will also compare these new biomarkers with recently FDA cleared CE-IVD assays for early detection of prostate cancer, based on classic peripheral tumour markers, such as Prostate Health Index (PHI) and PCA3. Follow up evaluations will be initiated to assess the prognostic relevance of the candidate biomarkers determined in this project. Here, the investigators will set up the data management system including all relevant information on the tissues collected and the results of the analyses as well as the clinical data of the patients investigated in this study.

The 2 groups in the trial

  • Men over 40 being suspicious of prostate cancerTreatment being tested

    Per patient 49 ml of peripheral blood sample after signing consent and performing before the 1st prostate biopsy

    Treatment: Blood sample

  • Men over 40 with no suspicion of prostate cancerTreatment being tested

    Per patient 49 ml of peripheral blood sample after signing consent

    Treatment: Blood sample

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Early Detection of Prostate Cancer by Liquid Biopsy
Plain-language title
Blood Test Study for Early Detection of Prostate CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
22 June 2026