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

  • End date
    May 4, 2027
  • participants needed
  • sponsor
    Institut Curie
Updated on 9 May 2022
Accepts healthy volunteers


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.


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

Condition Prostate Cancer, Healthy Donors
Treatment Urine sampling
Clinical Study IdentifierNCT05141383
SponsorInstitut Curie
Last Modified on9 May 2022


Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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