Prostate CancerPROLIPSYNCT04556916
Early Detection of Prostate Cancer
A study testing Blood sample in people with Prostate Cancer, run by University Hospital, Montpellier at 4 sites in France.
Trial summary
This study is the early detection of prostate cancer by analysing circulating bloodbased biomarkers. Based on our latest developments, we primarily aim to assess the validity of CTCs (circulating tumour cells) and tumour cell products circulating in blood (DNA, exosomes) for early PCa (Prostate cancer) detection. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 4 sitesFrance
- Study dates
- 19 Feb 2021to 15 Sep 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men over 40 being suspicious of prostate cancer
- Subject with PSA ≥ 4 and designated for biopsy
- Subjects must be able to attend all scheduled visits and to comply with all trial procedures
- mpMRI done before prostate biopsy
- Subject must be covered by public health insurance
- Signed informed consent form
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- Inclusion Criteria Subject Control Patient patient free from prostatic disease :
- Men over 40 with no suspicion of prostate cancer
- Subject with PSA < 2.5 and normal digital rectal examination
- Subject must be covered by public health insurance
- Signed informed consent form
Who cannot join
- Subject with histologically confirmed prostate cancer
- Subject with a verified viral infection (HIV or Hepatitis)
- Subject under Finasteride treatment
- Subject under hormonal treatment (analogs, antagonists, androgenics)
- Subject with other cancer diagnosed
- Subject unable to sign consent
Show all 21Show fewer
- Planned longer stay outside the region that prevents compliance with the visit plan
- Subject deprived of liberty, protected adults or vulnerable persons
- Urinary infection ≤ 2 months
- Subject excluding health insurance registration
- Subject refusing to perform prostate biopsy
- Subject who are in a dependency or employment with the sponsor or the investigator
- Subject with histologically confirmed prostate cancer
- Subject with a verified viral infection (HIV or Hepatitis)
- Subject under Finasteride treatment
- Subject with other cancer diagnosed
- Subject unable to sign consent
- Planned longer stay outside the region that prevents compliance with the visit plan
- Subject deprived of liberty, protected adults or vulnerable persons
- Urinary infection ≤ 2 months
- Subject excluding health insurance registration
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 3 recruiting
- Recruiting
CHU Montpellier - Département d'urologie et transplantation rénale
Montpellier
Rodolphe THURET, PU-PH, +33 4 67 33 87 42, r-thuret@chu-montpellier.fr
- Active, not recruiting
CHU Montpellier - Laboratoire des Cellules Circulantes Rares Humaines
Montpellier
- Recruiting
Clinique Beau Soleil - Service d'urologie
Montpellier
Xavier REBILLARD, MD-PhD, +33 4 67 75 97 70, xavier.Rébillard@wanadoo.fr
Bruno SEGUI, PH, +33 4 67 75 97 57, b.segui@languedoc-mutualite.fr
- Recruiting
CHU de Nîmes - Service Urologie Andrologie Sexologie
Nîmes
Stéphane DROUPY, MD-PhD, +33 6 88 63 99 72, stephane.droupy@chu-nimes.fr
About this study
Official title: Early Detection of Prostate Cancer by Liquid Biopsy
This study is the early detection of prostate cancer by analysing circulating bloodbased biomarkers. Based on our latest developments, we primarily aim to assess the validity of CTCs (circulating tumour cells) and tumour cell products circulating in blood (DNA, exosomes) for early PCa (Prostate cancer) detection.
In the first discovery period, the investigators will assess which Liquid biopsy marker will provide the best discrimination between the patients with histologically proven PCa and age-matched noncancer controls. Further subset analysis with special emphasis on the identification of high risk PCa patients with aggressive tumours as defined by a Gleason score ("gold standard") of 8 or higher (ISUP 4 and higher), will be performed. The resulting biomarker candidates will then be further explored in the subsequent training and validation study (years 2 and 3) in order to obtain the single blood test or combination of tests with the highest sensitivity and specificity for detection of early PCa and/or high-risk PCa. The investigators will also compare these new biomarkers with recently FDA cleared CE-IVD assays for early detection of prostate cancer, based on classic peripheral tumour markers, such as Prostate Health Index (PHI) and PCA3. Follow up evaluations will be initiated to assess the prognostic relevance of the candidate biomarkers determined in this project. Here, the investigators will set up the data management system including all relevant information on the tissues collected and the results of the analyses as well as the clinical data of the patients investigated in this study.
Read the detailed description
In this preclinical validation study patients suspicious of prostate cancer who will undergo initial prostate biopsy are going to be asked for blood samples during a routine visit. Each patient will have had an MRI (Magnetic Resonance Imaging) as part of the care before performing the biopsy. The investigators will draw a total of 49 ml peripheral blood from consented patients before the initial diagnostic biopsy is taken. Within this project, validation of liquid biopsy assays for early detection of prostate cancer patients is the primary goal.
In order to determine CTC numbers, 21 ml of blood will be subjected to either CTC-Capture, and 28 ml for the EPIDROP analysis according to standard protocol (For analysis of circulating blood products plasma, analysis of tumor specific mutations or promotor methylation, analysis of extracellular vesicles and microRNA). The investigators will also analyze the Prostate Health Index marker from the additional EDTA tube (7 ml).
The investigators will assess whether CTC counts and/or detection of tumor specific blood products will provide discrimination between the men with histologically proven prostate cancer and agematched non-cancer controls as well as identification of high-risk PCa patients.
Furthermore, the investigators will compare results from tested liquid biopsy assay with current standard of early prostate cancer detection using both serum PSA and digital rectal examination, MRImp and PSA density.
The discovery phase is a non-blind study on 70 subjects with elevated PSA, and 50 negative controls (Healthy patients no suspicion of prostate cancer; PSA<2.5). The 70 patients are patients with suspected prostate cancer and will undergo prostate biopsy.
The samples will be tested for the 3 biomarkers (CTCs, cfDNA, exosome). The validation study is a non-blind study on 167 subjects with elevated PSA and designated for a biopsy (this biopsy may be positive (presence of cancer) or negative (no cancer revealed by the biopsy)), and 33 negative controls. The samples will be tested with the best biomarkers or biomarker combination selected in the discovery phase.
- Conditions
- Prostate Cancer
- Being tested
- Blood sample
- Keywords
- prostate cancer, liquid biopsy, circulating tumour cells
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Per patient 49 ml of peripheral blood sample :
- 21ml divided into 3 TransFix or EDTA 7ml tubes will be sent to Hamburg for subsequent CTCapture analysis;
- 28ml divided into 4 EDTA 7ml tubes will be sent to Montpellier for subsequent EPIDROP analysis (21 ml), PHI analysis (7 ml) and plasma isolation.
| Study group | Role | What they receive |
|---|---|---|
| Men over 40 being suspicious of prostate cancer | Experimental | Per patient 49 ml of peripheral blood sample after signing consent and performing before the 1st prostate biopsy Receives: Diagnostic Test: Blood sample |
| Men over 40 with no suspicion of prostate cancer | Experimental | Per patient 49 ml of peripheral blood sample after signing consent Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discovery of CTCs and tumour cell products circulating in blood (DNA, exosomes) for early PCa detection.
Evaluate Liquid biopsy marker between the patients with histologically proven PCa and age-matched noncancer controls.
Measured: Expected duration of the recruitment of the discovery phase: 12 months
Secondary outcomes (3)
Detection duration of the recruitment of the validation study.
The most marker(s) assay(s) will be further explored in the subsequent training and validation study in order to obtain the blood test to detect early prostate cancer in patients with elevated serum PSA.
Measured: Expected duration of the recruitment of the validation study: 24 months
Validity of blood test with the highest specificity for detection of early PCa and/or high-risk PCa.
Combination of complementary circulating biomarkers as liquid biopsy of cancer (CTCs, circulating tumor DNA \& exosomes).
Measured: Expected duration of the recruitment of the validation study: 24 months
Validity of blood test with the highest specificity for detection of early PCa and/or high-risk PCa.
Measure the prognostic relevance of candidate biomarkers
Measured: Expected duration of the recruitment of the validation study: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start19 Feb 2021
- Primary completion15 Nov 2023
- Study completion15 Sep 2033 (estimated)
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.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine ALIX-PANABIERES, MCU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556916
- Sponsor's protocol ID
- RECHMPL21_0137
- Other IDs
- 2019-A02253-54
- Acronym
- PROLIPSY
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2020
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Prostate Cancer by Liquid Biopsy
- ClinicalTrials.gov ID
- NCT04556916
- Acronym / sponsor ID
- PROLIPSY / RECHMPL21_0137
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, liquid biopsy, circulating tumour cells
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Sep 2033 (estimated)
- First posted
- 21 Sep 2020 (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.
This study is the early detection of prostate cancer by analysing circulating bloodbased biomarkers. Based on our latest developments, we primarily aim to assess the validity of CTCs (circulating tumour cells) and tumour cell products circulating in blood (DNA, exosomes) for early PCa (Prostate cancer) detection.
In the first discovery period, the investigators will assess which Liquid biopsy marker will provide the best discrimination between the patients with histologically proven PCa and age-matched noncancer controls. Further subset analysis with special emphasis on the identification of high risk PCa patients with aggressive tumours as defined by a Gleason score ("gold standard") of 8 or higher (ISUP 4 and higher), will be performed. The resulting biomarker candidates will then be further explored in the subsequent training and validation study (years 2 and 3) in order to obtain the single blood test or combination of tests with the highest sensitivity and specificity for detection of early PCa and/or high-risk PCa. The investigators will also compare these new biomarkers with recently FDA cleared CE-IVD assays for early detection of prostate cancer, based on classic peripheral tumour markers, such as Prostate Health Index (PHI) and PCA3. Follow up evaluations will be initiated to assess the prognostic relevance of the candidate biomarkers determined in this project. Here, the investigators will set up the data management system including all relevant information on the tissues collected and the results of the analyses as well as the clinical data of the patients investigated in this study.
Detailed description
In this preclinical validation study patients suspicious of prostate cancer who will undergo initial prostate biopsy are going to be asked for blood samples during a routine visit. Each patient will have had an MRI (Magnetic Resonance Imaging) as part of the care before performing the biopsy. The investigators will draw a total of 49 ml peripheral blood from consented patients before the initial diagnostic biopsy is taken. Within this project, validation of liquid biopsy assays for early detection of prostate cancer patients is the primary goal.
In order to determine CTC numbers, 21 ml of blood will be subjected to either CTC-Capture, and 28 ml for the EPIDROP analysis according to standard protocol (For analysis of circulating blood products plasma, analysis of tumor specific mutations or promotor methylation, analysis of extracellular vesicles and microRNA). The investigators will also analyze the Prostate Health Index marker from the additional EDTA tube (7 ml).
The investigators will assess whether CTC counts and/or detection of tumor specific blood products will provide discrimination between the men with histologically proven prostate cancer and agematched non-cancer controls as well as identification of high-risk PCa patients.
Furthermore, the investigators will compare results from tested liquid biopsy assay with current standard of early prostate cancer detection using both serum PSA and digital rectal examination, MRImp and PSA density.
The discovery phase is a non-blind study on 70 subjects with elevated PSA, and 50 negative controls (Healthy patients no suspicion of prostate cancer; PSA<2.5). The 70 patients are patients with suspected prostate cancer and will undergo prostate biopsy.
The samples will be tested for the 3 biomarkers (CTCs, cfDNA, exosome). The validation study is a non-blind study on 167 subjects with elevated PSA and designated for a biopsy (this biopsy may be positive (presence of cancer) or negative (no cancer revealed by the biopsy)), and 33 negative controls. The samples will be tested with the best biomarkers or biomarker combination selected in the discovery phase.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men over 40 being suspicious of prostate cancer | Experimental | Diagnostic Test: Blood samplePer patient 49 ml of peripheral blood sample after signing consent and performing before the 1st prostate biopsy |
| Men over 40 with no suspicion of prostate cancer | Experimental | Diagnostic Test: Blood samplePer patient 49 ml of peripheral blood sample after signing consent |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men over 40 being suspicious of prostate cancer
- Subject with PSA ≥ 4 and designated for biopsy
- Subjects must be able to attend all scheduled visits and to comply with all trial procedures
- mpMRI done before prostate biopsy
- Subject must be covered by public health insurance
Key exclusion criteria (21 listed)
- Subject with histologically confirmed prostate cancer
- Subject with a verified viral infection (HIV or Hepatitis)
- Subject under Finasteride treatment
- Subject under hormonal treatment (analogs, antagonists, androgenics)
- Subject with other cancer diagnosed
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 |
|---|---|---|
| Blood samplePer patient 49 ml of peripheral blood sample : * 21ml divided into 3 TransFix or EDTA 7ml tubes will be sent to Hamburg for subsequent CTCapture analysis; * 28ml divided into 4 EDTA 7ml tubes will be sent to Montpellier for subsequent EPIDROP analysis (21 ml), PHI analysis (7 ml) and plasma isolation. | Diagnostic test | Men over 40 being suspicious of prostate cancer, Men over 40 with no suspicion of prostate cancer |
Primary outcome
Discovery of CTCs and tumour cell products circulating in blood (DNA, exosomes) for early PCa detection.
Time frame: Expected duration of the recruitment of the discovery phase: 12 months
Evaluate Liquid biopsy marker between the patients with histologically proven PCa and age-matched noncancer controls.
3 secondary outcomes
Detection duration of the recruitment of the validation study.
Time frame: Expected duration of the recruitment of the validation study: 24 months
Validity of blood test with the highest specificity for detection of early PCa and/or high-risk PCa.
Time frame: Expected duration of the recruitment of the validation study: 24 months
Validity of blood test with the highest specificity for detection of early PCa and/or high-risk PCa.
Time frame: Expected duration of the recruitment of the validation study: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Catherine ALIX-PANABIERES, MCU-PH principal investigator
University Hospital, Montpellier
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Prostate Cancer, run by University Hospital, Montpellier at 4 sites 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 11 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine ALIX-PANABIERES, MCU-PH (+33 4 11 75 99 31, c-panabieres@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discovery of CTCs and tumour cell products circulating in blood (DNA, exosomes) for early PCa detection. (time frame: Expected duration of the recruitment of the discovery phase: 12 months). 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 22 Jun 2026.