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

NCT ID: NCT04702633

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 127 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2022-05-30

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Confirmed diagnosis group

Patients with a diagnosis of prostate cancer (metastatic or advanced) before prostatectomy.

Results obtained by biopsy and MRI results.

Intervention Type: OTHER

Results obtained by biopsy and MRI results.

Clinical data

Intervention Type: OTHER

Clinical data

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.

Results obtained by biopsy and MRI results.

Intervention Type: OTHER

Results obtained by biopsy and MRI results.

Clinical data

Intervention Type: OTHER

Clinical data

Interventions

Results obtained by biopsy and MRI results.

Results obtained by biopsy and MRI results.

Intervention Type: OTHER

Clinical data

Clinical data

Intervention Type: OTHER

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rarecells Diagnostics SAS

INDUSTRY

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrizia PATERLINI-BRECHOT, MD, PhD

Role: STUDY_CHAIR

INSERM and Rarecells Diagnostics

Locations

Cochin Hospital

Paris, , France

Countries

France

Other Identifiers

APHP201309

Identifier Type: -

Identifier Source: org_study_id