PROSTA-PAPNon-invasive Isolation and Characterization of Prostate Tumor Cells for Prostate Cancer Diagnosis
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: March 19, 2021
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.127 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location