Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy

Study Overview
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Brief Summary
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Constitution of a biological collection within the framework of the establishment of a diagnostic, prognostic and active surveillance test for prostate cancer from long non-coding RNA biomarkers, in 3 cohorts of patients, with cancer of the prostate, with suspected cancer without biopsy confirmation or with prostatic hyperplasia and healthy donors. This biological collection will also be used as a support for further researches on the identification of biomarkers and genetic markers to improve the prognosis and diagnostic management of patients with prostate pathologies.

Detailed Description
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Multicenter, RIPH 2 study, evaluating on 3 patient cohorts the feasibility of setting up a diagnostic test, prognosis and active surveillance of prostate cancer using long non-coding RNA biomarkers. For patients agreeing to participate in the study and having signed a consent form, during their routine care consultation in the urology department, will have a blood sample and a urine sample after prostate massage as part of the study, and if necessary, a tissue sample as part of the treatment. Patients with prostate cancer will be followed as part of their care at least annually, and their follow-up data will be collected as part of the study, without additional sampling. A blood sample and a urine sample after prostate massage will be carried out during a single consultation at the CIC Henri Mondor for

Official Title
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Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy

Conditions
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Prostate Cancer, Healthy Donors

Intervention / Treatment
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* Other: Urine sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Concerning patients: / Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level> 4 ng / ml / Patients with cancer detected after biopsy including 3 groups of 10 patients with Gleason score> = 8 (High Risk), 7 (intermediate Risk), or <= 6 (low risk) / Patients diagnosed by prostate MRI in the course of treatment / Information of the patient and signature of informed consent or his legal representative. / Participant affiliated to a social security scheme Regarding healthy volunteers: / Male from 50 to 70 years old / PSA level <4 ng / mL / No infectious episode in the week before the visit (in particular no urinary tract infection), documented by dipstick and the absence of fever / Absence of cancer and history of haematological pathologies (in particular leukemia, lymphoma). / Patient information and signature of consent Exclusion Criteria: 1 / Participants who refused to participate in the biological collection 2) Persons deprived of their liberty or under guardianship. 3) Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 cohorts will be included in the study: 40 patients with prostate cancer, or 40 patients with suspected cancer without confirmation on biopsy, or with hyperplasia of the prostate and 38 healthy donors.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with prostate cancer<br>Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level> 4 ng / ml | Other: Urine sampling<br>* A blood sample and a urine sample after prostate massage will be carried out at baseline<br>* Other names: Blood sampling;|
| Other: Patients with suspected cancer without confirmation on biopsy, or with hyperplasia of the prostate<br>Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level> 4 ng / ml | Other: Urine sampling<br>* A blood sample and a urine sample after prostate massage will be carried out at baseline<br>* Other names: Blood sampling;|
| Other: Healthy donors<br>Male from 50 to 70 years old with a PSA level <4 ng / mL | Other: Urine sampling<br>* A blood sample and a urine sample after prostate massage will be carried out at baseline<br>* Other names: Blood sampling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extracting extravesicular particles and RNA from urine fluids | Criteria will be a minimum of 10ng of total RNA extracted per sample total RNA sequencing and greater than 10 million unique reads mapping to the Gencode V32 reference genome. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extracting extravesicular particles and RNA from blood | Criteria will be a minimum of 10ng of total RNA extracted per sample total RNA sequencing and greater than 10 million unique reads mapping to the Gencode V32 reference genome. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnostic, prognosis, prostate cancer, long non-coding RNA biomarkers