RecruitingNot ApplicableNCT04556916

Early Detection of Prostate Cancer

Early Detection of Prostate Cancer by Liquid Biopsy


Sponsor

University Hospital, Montpellier

Enrollment

320 participants

Start Date

Feb 19, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This French study is developing and testing a new tool — possibly a urine or blood test — to help detect prostate cancer earlier and more accurately, comparing men with suspected prostate cancer to healthy men without any prostate problems. **You may be eligible if...** - You are a man over 40 either with suspicion of prostate cancer (PSA level 4 or higher, scheduled for biopsy) OR with no signs of prostate disease (PSA below 2.5, normal rectal exam) - You have had an MRI of the prostate before biopsy (for the suspected cancer group) - You are covered by French public health insurance **You may NOT be eligible if...** - You have already been diagnosed with prostate cancer - You have HIV or hepatitis - You are on finasteride or hormone treatments - You have another active cancer - You had a urinary tract infection in the last 2 months - You are unwilling to have a prostate biopsy (for the suspected cancer group) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBlood 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.


Locations(4)

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

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NCT04556916


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