Prostate CancerPROSTA-PAPNCT04702633
Immuno-molecular Approaches for Non-invasive Diagnosis of Prostate Cancer
An observational study of Prostate Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to isolate and characterize tumor cells non-invasively from biological samples in patients with prostate cancer and demonstrate the ability to identify the presence and number of tumor cells before prostate biopsy. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Results obtained by biopsy and MRI results. and Clinical data
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2021to 30 May 2022
- Phase
- Observational
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients consulting the urology department of Cochin Hospital with an indication for prostate biopsy or as part of the monitoring of prostate cancer may be included.
Who may be able to join
- Patients with a diagnosis of localized or metastatic prostate cancer.
- No prior or other oncological treatment.
- Patients undergoing prostate biopsy in the context of prostate cancer diagnosis.
- Patients with an elevation of PSA (Prostate Specific Antigen), an abnormality on the rectal examination and / or an MRI signal motivating a prostate biopsy,
- Patients informed and not opposed to participating in the research
Who cannot join
- Patients not affiliated with French social security.
- Patients unable to understand the protocol.
- Patients diagnosed with another type of cancer within the past 5 years.
- Patients prostatectomized and/or treated for prostate cancer.
- Patients who wear a bladder catheter
- Patients under guardianship or curatorship
- Patients under AME
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Isolation and Characterization of Prostate Tumor Cells for Prostate Cancer Diagnosis
The purpose of this study is to isolate and characterize tumor cells non-invasively from biological samples in patients with prostate cancer and demonstrate the ability to identify the presence and number of tumor cells before prostate biopsy.
Read the detailed description
Prostate cancer is one of the most frequently diagnosed cancers and a leading cause of cancer death in men worldwide. Existing methods of diagnosis and monitoring of prostate cancer are inadequate due to their invasiveness, inaccuracy, cost, access uneven, etc., making difficult the diagnosis and patient's follow up. New techniques and methods are necessary to improve diagnosis.
Biological liquids might represent an attractive target to isolate prostate tumour cells for these purposes. In recent years, several studies have been carried out with the aim of reducing and / or avoiding the limits of sensitivity and specificity of current methods of screening for prostate cancer and thus obtain new biomarkers for the diagnosis and / or non-invasive monitoring.
However, due to technical and technological difficulties few studies have been performed to investigate the non-invasive isolation and direct analysis of tumour cells. Our project is therefore an innovative project which aims to study a new approach for the early diagnosis of prostate cancer, with better sensitivity and specificity.
- Conditions
- Prostate Cancer
- Being tested
- Results obtained by biopsy and MRI results., Clinical data
- Keywords
- Prostate cancer, Liquid biopsy, Biological samples, Non-invasive diagnosis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Results obtained by biopsy and MRI results.Other
Results obtained by biopsy and MRI results.
Clinical dataOther
Clinical data
| Study group | Role | What they receive |
|---|---|---|
| Confirmed diagnosis group | Patients with a diagnosis of prostate cancer (metastatic or advanced) before prostatectomy. Receives: Other: Results obtained by biopsy and MRI results.; Other: Clinical data | |
| Pre-diagnosis group | Patients undergoing prostate biopsy in the context of prostate cancer diagnosis: PSA increases, and / or abnormal digital rectal examination (DRE) and / or an MRI detected signal. Receives: Other: Results obtained by biopsy and MRI results.; Other: Clinical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and number of prostate tumour cells in biological samples
Cell enrichment will be carried out using the ISET® (Isolation by SizE of Tumor/Trophoblastic cells) technology. Identification will be performed by different spectroscopic and/or immune-molecular and/or cytological approaches
Measured: One month after biopsy or until the histological diagnosis will be obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start19 Mar 2021
- Primary completion30 Apr 2022
- Study completion30 May 2022
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 Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Rarecells Diagnostics SAS, Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Patrizia PATERLINI-BRECHOT, MD, PhD, Study chair, INSERM and Rarecells Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702633
- Sponsor's protocol ID
- APHP201309
- Acronym
- PROSTA-PAP
- Status last verified
- Oct 2025
- First submitted
- 7 Jan 2021
- Last updated
- 20 Nov 2025
- 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Isolation and Characterization of Prostate Tumor Cells for Prostate Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT04702633
- Acronym / sponsor ID
- PROSTA-PAP / APHP201309
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Liquid biopsy, Biological samples, Non-invasive diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Rarecells Diagnostics SAS, Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 11 Jan 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.
The purpose of this study is to isolate and characterize tumor cells non-invasively from biological samples in patients with prostate cancer and demonstrate the ability to identify the presence and number of tumor cells before prostate biopsy.
Detailed description
Prostate cancer is one of the most frequently diagnosed cancers and a leading cause of cancer death in men worldwide. Existing methods of diagnosis and monitoring of prostate cancer are inadequate due to their invasiveness, inaccuracy, cost, access uneven, etc., making difficult the diagnosis and patient's follow up. New techniques and methods are necessary to improve diagnosis.
Biological liquids might represent an attractive target to isolate prostate tumour cells for these purposes. In recent years, several studies have been carried out with the aim of reducing and / or avoiding the limits of sensitivity and specificity of current methods of screening for prostate cancer and thus obtain new biomarkers for the diagnosis and / or non-invasive monitoring.
However, due to technical and technological difficulties few studies have been performed to investigate the non-invasive isolation and direct analysis of tumour cells. Our project is therefore an innovative project which aims to study a new approach for the early diagnosis of prostate cancer, with better sensitivity and specificity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Confirmed diagnosis group | – | Other: Results obtained by biopsy and MRI results., Other: Clinical dataPatients with a diagnosis of prostate cancer (metastatic or advanced) before prostatectomy. |
| Pre-diagnosis group | – | Other: Results obtained by biopsy and MRI results., Other: Clinical dataPatients undergoing prostate biopsy in the context of prostate cancer diagnosis: PSA increases, and / or abnormal digital rectal examination (DRE) and / or an MRI detected signal. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients consulting the urology department of Cochin Hospital with an indication for prostate biopsy or as part of the monitoring of prostate cancer may be included.
Key inclusion criteria (5 listed)
- Patients with a diagnosis of localized or metastatic prostate cancer.
- No prior or other oncological treatment.
- Patients undergoing prostate biopsy in the context of prostate cancer diagnosis.
- Patients with an elevation of PSA (Prostate Specific Antigen), an abnormality on the rectal examination and / or an MRI signal motivating a prostate biopsy,
- Patients informed and not opposed to participating in the research
Key exclusion criteria (7 listed)
- Patients not affiliated with French social security.
- Patients unable to understand the protocol.
- Patients diagnosed with another type of cancer within the past 5 years.
- Patients prostatectomized and/or treated for prostate cancer.
- Patients who wear a bladder catheter
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 |
|---|---|---|
| Results obtained by biopsy and MRI results.Results obtained by biopsy and MRI results. | Other | Confirmed diagnosis group, Pre-diagnosis group |
| Clinical dataClinical data | Other | Confirmed diagnosis group, Pre-diagnosis group |
Primary outcome
Presence and number of prostate tumour cells in biological samples
Time frame: One month after biopsy or until the histological diagnosis will be obtained
Cell enrichment will be carried out using the ISET® (Isolation by SizE of Tumor/Trophoblastic cells) technology. Identification will be performed by different spectroscopic and/or immune-molecular and/or cytological approaches
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 20 Nov 2025.
- 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. This study is not recruiting at the moment.
Patrizia PATERLINI-BRECHOT, MD, PhD study chair
INSERM and Rarecells Diagnostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 7 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 20 Nov 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?
Presence and number of prostate tumour cells in biological samples (time frame: One month after biopsy or until the histological diagnosis will be obtained). 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 20 Nov 2025.