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

Not Applicable

Recruiting

• Conditions: Healthy Donors; Prostate Cancer
• Interventions: Other: Urine sampling

• Registration Number: NCT05141383
• Lead Sponsor: Institut Curie

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-12-02
• Study Start: 2022-05-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2024-10-24
• Study Completion: 2024-10-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

Concerning patients:

1. / Patient with suspected prostate cancer or prostatic hyperplasia with a PSA level ≥ 4 ng / ml
2. / Patient diagnosed by prostate MRI in the course of treatment
3. / No infectious episode in the week before the visit (in particular no urinary tract infection) documented by dipstick and absence of fever
4. / Information of the patient and signature of informed consent or his legal representative.
5. / Participant affiliated to a social security scheme

Regarding healthy volunteers:

1. / Male from 50 to 70 years old
2. / PSA level < 4 ng / mL
3. / No infectious episode in the week before the visit (in particular no urinary tract infection), documented by dipstick and the absence of fever
4. / Absence of cancer and history of haematological pathologies < 5 years (in particular leukemia, lymphoma).
5. / 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy donors	Urine sampling	Male from 50 to 70 years old with a PSA level \<4 ng / mL
Patients with prostate cancer	Urine sampling	Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level\> 4 ng / ml
Patients with suspected cancer without confirmation on biopsy, or with hyperplasia of the prostate	Urine sampling	Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level\> 4 ng / ml

Primary Outcome Measures

Name	Time	Method
Extracting extravesicular particles and RNA from urine fluids	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Extracting extravesicular particles and RNA from blood	Baseline	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.

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France