Prostate CancerHOPENCT05141383
Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy (HOPE)
A study testing Urine sampling in people with Prostate Cancer and Healthy Donors, run by Institut Curie at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Healthy Donors
- What is being tested?
- Urine sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2022to 3 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy
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.
Read the 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
- Conditions
- Prostate Cancer, Healthy Donors
- Being tested
- Urine sampling
- Keywords
- diagnostic, prognosis, prostate cancer, long non-coding RNA biomarkers
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine samplingOther
Also called Blood sampling
A blood sample and a urine sample after prostate massage will be carried out at baseline
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Urine sampling |
| Healthy donors | Other | Male from 50 to 70 years old with a PSA level <4 ng / mL Receives: Other: Urine sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start4 May 2022
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves ALLORY, MD PhD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141383
- Sponsor's protocol ID
- IC 2021-04
- Acronym
- HOPE
- Status last verified
- Sep 2024
- First submitted
- 19 Nov 2021
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy
- ClinicalTrials.gov ID
- NCT05141383
- Acronym / sponsor ID
- HOPE / IC 2021-04
- Conditions
- Prostate Cancer, Healthy Donors
- Keywords
- diagnostic, prognosis, prostate cancer, long non-coding RNA biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with prostate cancer | Other | Other: Urine samplingPatients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level> 4 ng / ml |
| Patients with suspected cancer without confirmation on biopsy, or with hyperplasia of the prostate | Other | Other: Urine samplingPatients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level> 4 ng / ml |
| Healthy donors | Other | Other: Urine samplingMale from 50 to 70 years old with a PSA level <4 ng / mL |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- / 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine samplingAlso: Blood samplingA blood sample and a urine sample after prostate massage will be carried out at baseline | Other | Healthy donors, Patients with prostate cancer, Patients with suspected cancer without confirmation on biopsy, or with hyperplasia of the prostate |
Primary outcome
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.
1 secondary outcome
Extracting extravesicular particles and RNA from blood
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves ALLORY, MD PhD principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine sampling in people with Prostate Cancer and Healthy Donors, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracting extravesicular particles and RNA from urine fluids (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.