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

Primary Purpose

Prostate Cancer, Healthy Donors

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Urine sampling

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring diagnostic, prognosis, prostate cancer, long non-coding RNA biomarkers

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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:

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.

Sites / Locations

Institut CurieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Patients with prostate cancer

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

Healthy donors

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Extracting extravesicular particles and RNA from blood

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.

Full Information

NCT ID

NCT05141383

First Posted

November 19, 2021

Last Updated

July 18, 2023

Sponsor

Institut Curie

1. Study Identification

Unique Protocol Identification Number

NCT05141383

Brief Title

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

Acronym

HOPE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 4, 2022 (Actual)

Primary Completion Date

May 8, 2028 (Anticipated)

Study Completion Date

May 9, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Curie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Healthy Donors

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

3 cohorts 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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with prostate cancer

Arm Type

Other

Arm Description

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

Arm Title

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

Arm Type

Other

Arm Description

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

Arm Title

Healthy donors

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Urine sampling

Other Intervention Name(s)

Blood sampling

Intervention Description

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

Primary Outcome Measure Information:

Title

Extracting extravesicular particles and RNA from urine fluids

Description

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.

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Extracting extravesicular particles and RNA from blood

Description

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.

Time Frame

Baseline

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Prostate cancer or suspicion of prostate cancer

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sandra NESPOULOUS

Phone

+331 56 24 56 30

drci.promotion@curie.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Antonin MORILLON, PhD

Phone

+331 56 24 56 30

drci.promotion@curie.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yves ALLORY, MD PhD

Organizational Affiliation

Institut Curie

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Curie

City

Paris

ZIP/Postal Code

75005

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie-Emmanuelle LEGRIER, PhD

Phone

+331 44 32 40 00.

drci.promotion@curie.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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