Clinical trial NCT05141383: Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy
Official title: Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Healthy Donors
Keywords: diagnostic
prognosis
prostate cancer
long non-coding RNA biomarkers
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 80
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 cohorts of 118 patients in the aim to have 90 evaluable participants 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.
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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.

Primary outcomes:
measure: Extracting extravesicular particles and RNA from urine fluids
timeFrame: Baseline
Secondary outcomes:
measure: Extracting extravesicular particles and RNA from blood
timeFrame: Baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: Yves ALLORY, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: