Immuno-molecular Approaches for Non-invasive Diagnosis of Prostate Cancer

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT04702633
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Study Start: 2021-03-19
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-30
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 127

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence and number of prostate tumour cells in biological samples	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

Trial Locations

Locations (1)

Cochin Hospital; 🇫🇷 Paris, France