Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
320 participants
INTERVENTIONAL
2021-02-19
2033-09-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Immuno-molecular Approaches for Non-invasive Diagnosis of Prostate Cancer
NCT04702633
Investigation of Urinary Biomarkers for the Detection of Prostate Cancer
NCT05454371
Markers for Early Detection of Prostate Cancer
NCT00340717
Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy
NCT00373035
PRO-STATE:Search for a Protein Profile Corresponding to Fast-developing Lesions and Characterization of Implicated Proteins in Prostate Carcinoma
NCT00427817
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In order to determine CTC numbers, 21 ml of blood will be subjected to either CTC-Capture, and 28 ml for the EPIDROP analysis according to standard protocol (For analysis of circulating blood products plasma, analysis of tumor specific mutations or promotor methylation, analysis of extracellular vesicles and microRNA). The investigators will also analyze the Prostate Health Index marker from the additional EDTA tube (7 ml).
The investigators will assess whether CTC counts and/or detection of tumor specific blood products will provide discrimination between the men with histologically proven prostate cancer and agematched non-cancer controls as well as identification of high-risk PCa patients.
Furthermore, the investigators will compare results from tested liquid biopsy assay with current standard of early prostate cancer detection using both serum PSA and digital rectal examination, MRImp and PSA density.
The discovery phase is a non-blind study on 70 subjects with elevated PSA, and 50 negative controls (Healthy patients no suspicion of prostate cancer; PSA\<2.5). The 70 patients are patients with suspected prostate cancer and will undergo prostate biopsy.
The samples will be tested for the 3 biomarkers (CTCs, cfDNA, exosome). The validation study is a non-blind study on 167 subjects with elevated PSA and designated for a biopsy (this biopsy may be positive (presence of cancer) or negative (no cancer revealed by the biopsy)), and 33 negative controls. The samples will be tested with the best biomarkers or biomarker combination selected in the discovery phase.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Men over 40 being suspicious of prostate cancer
Per patient 49 ml of peripheral blood sample after signing consent and performing before the 1st prostate biopsy
Blood sample
Per patient 49 ml of peripheral blood sample :
* 21ml divided into 3 TransFix or EDTA 7ml tubes will be sent to Hamburg for subsequent CTCapture analysis;
* 28ml divided into 4 EDTA 7ml tubes will be sent to Montpellier for subsequent EPIDROP analysis (21 ml), PHI analysis (7 ml) and plasma isolation.
Men over 40 with no suspicion of prostate cancer
Per patient 49 ml of peripheral blood sample after signing consent
Blood sample
Per patient 49 ml of peripheral blood sample :
* 21ml divided into 3 TransFix or EDTA 7ml tubes will be sent to Hamburg for subsequent CTCapture analysis;
* 28ml divided into 4 EDTA 7ml tubes will be sent to Montpellier for subsequent EPIDROP analysis (21 ml), PHI analysis (7 ml) and plasma isolation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood sample
Per patient 49 ml of peripheral blood sample :
* 21ml divided into 3 TransFix or EDTA 7ml tubes will be sent to Hamburg for subsequent CTCapture analysis;
* 28ml divided into 4 EDTA 7ml tubes will be sent to Montpellier for subsequent EPIDROP analysis (21 ml), PHI analysis (7 ml) and plasma isolation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
40 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Montpellier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Catherine ALIX-PANABIERES, MCU-PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Montpellier - Département d'urologie et transplantation rénale
Montpellier, , France
CHU Montpellier - Laboratoire des Cellules Circulantes Rares Humaines
Montpellier, , France
Clinique Beau Soleil - Service d'urologie
Montpellier, , France
CHU de Nîmes - Service Urologie Andrologie Sexologie
Nîmes, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-A02253-54
Identifier Type: OTHER
Identifier Source: secondary_id
RECHMPL18_0014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.