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

Prostate Cancer Clinical Trial

— PROSTA-PAP  

Official title:

Non-invasive Isolation and Characterization of Prostate Tumor Cells for Prostate Cancer Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04702633
• Other study ID #: APHP201309
• Status: Recruiting
• Start date: March 19, 2021
• Est. completion date: March 19, 2024

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Julien ANRACT, MD
• Phone: + 33(0)1 58 41 33 55
• Email: julien.anract[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 19, 2024
• Est. primary completion date: March 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Results obtained by biopsy and MRI results.
Results obtained by biopsy and MRI results.
• Clinical data
Clinical data

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France, Rarecells Diagnostics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One month after biopsy or until the histological diagnosis will be obtained