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

NCT05141383 | Completed

• 1 other identifier: IC 2021-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Healthy Donors

Keywords

diagnostic; prognosis; prostate cancer; long non-coding RNA biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Extracting extravesicular particles and RNA from blood

  Baseline

Study Arms (3)

Patients with prostate cancer

OTHER

Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level\> 4 ng / ml

Other: Urine sampling

Patients with suspected cancer without confirmation on biopsy, or with hyperplasia of the prostate

OTHER

Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level\> 4 ng / ml

Other: Urine sampling

Healthy donors

OTHER

Male from 50 to 70 years old with a PSA level \<4 ng / mL

Other: Urine sampling

Interventions

Urine sampling OTHER

A blood sample and a urine sample after prostate massage will be carried out at baseline

Also known as: Blood sampling

Healthy donors; Patients with prostate cancer; Patients with suspected cancer without confirmation on biopsy, or with hyperplasia of the prostate

Eligibility Criteria

• Age: 50 Years - 70 Years
• Gender Eligibility Details: Prostate cancer or suspicion of prostate cancer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Concerning patients:
• / Patient with suspected prostate cancer or prostatic hyperplasia with a PSA level ≥ 4 ng / ml
• / Patient diagnosed by prostate MRI in the course of treatment
• / No infectious episode in the week before the visit (in particular no urinary tract infection) documented by dipstick and absence of fever
• / 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 \< 5 years (in particular leukemia, lymphoma).
• / Patient information and signature of consent

You may not qualify if:

• / 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yves ALLORY, MD PhD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: May 4, 2022
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: September 8, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (1)