NCT04556916Recruiting
Early Detection of Prostate Cancer
Early Detection of Prostate Cancer by Liquid Biopsy
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 23 Jun 2020
- Start date
- 19 Feb 2021
- Primary completion date
- 15 Nov 2023
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Prostate cancer
- NCT number
- NCT04556916
What you commit to
- Study type: Interventional
- Planned participants: 320
- From 19 Feb 2021 to the primary completion date, 15 Nov 2023
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Montpellier - Département d'urologie et transplantation rénale Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU Montpellier - Laboratoire des Cellules Circulantes Rares Humaines Coordinator of this site? Confirm its status | Montpellier | France | Active, not recruiting |
| Clinique Beau Soleil - Service d'urologie Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU de Nîmes - Service Urologie Andrologie Sexologie Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.