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NCT Number: NCT05141383

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

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.

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Key information

Conditions

Prostate Cancer Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Healthy Donors Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie

Paris, 75005, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Urine sampling

Other

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

Other names: Blood sampling

Primary outcomes

  1. Extracting extravesicular particles and RNA from urine fluids

    Time frame: 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 outcomes

  1. Extracting extravesicular particles and RNA from blood

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

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

Acronym: HOPE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2021
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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