Clinical trial NCT04702633: Immuno-molecular Approaches for Non-invasive Diagnosis of Prostate Cancer
Official title: Non-invasive Isolation and Characterization of Prostate Tumor Cells for Prostate Cancer Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: Prostate cancer
Liquid biopsy
Biological samples
Non-invasive diagnosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Rarecells Diagnostics SAS
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2021-01-11
Enrollment: 200
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence and number of prostate tumour cells in biological samples
timeFrame: One month after biopsy or until the histological diagnosis will be obtained
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: INSERM and Rarecells Diagnostics
name: Patrizia PATERLINI-BRECHOT, MD, PhD
role: STUDY_CHAIR
References: