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OpenTrials
Completed

NCT Number: NCT04702633

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Results obtained by biopsy and MRI results.

Other

Results obtained by biopsy and MRI results.

Clinical data

Other

Clinical data

Primary outcomes

  1. Presence and number of prostate tumour cells in biological samples

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • Rarecells Diagnostics SAS
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: PROSTA-PAP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2021
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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