Immuno-molecular Approaches for Non-invasive Diagnosis of Prostate Cancer (PROSTA-PAP)
Non-invasive Isolation and Characterization of Prostate Tumor Cells for Prostate Cancer Diagnosis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75014
- Cochin Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Confirmed diagnosis group
Patients with a diagnosis of prostate cancer (metastatic or advanced) before prostatectomy.
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Clinical data
Results obtained by biopsy and MRI results.
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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.
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Clinical data
Results obtained by biopsy and MRI results.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Presence and number of prostate tumour cells in biological samples
Time Frame: One month after biopsy or until the histological diagnosis will be obtained
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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
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One month after biopsy or until the histological diagnosis will be obtained
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Patrizia PATERLINI-BRECHOT, MD, PhD, INSERM and Rarecells Diagnostics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP201309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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