Test Semiquantitative Prostate Specific Antigen (PSA)

November 19, 2025 updated by: Institut Curie

Validation of a Semiquantitative Screening Assay for PSA

The aim of the study is to compare the diagnostic performances of a simple and rapid PSA assay on whole blood to the standard plasma PSA assay.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Screening and surveillance of prostate cancer typically involves sensitive laboratory techniques for the quantification of plasma prostate specific antigen (PSA). In this study, we determine the sensitivity and specificity of a simple test strip based PSA assay using only a few drops of whole blood as compared to a standard plasma PSA assay. Blood samples will be taken from hundred patients who are followed for a prostatic disease needing PSA surveillance. Before decantation of the samples, a few drops of blood will serve for the rapid test on strips. Plasma PSA levels will be determined with the TRACE ("Time Resolved Amplified Cryptate Emission") technology in homogeneous liquid phase. The results from the rapid test can then be compared to the plasma levels obtained by TRACE.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Cloud, France, 92210
        • Centre René Huguenin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients followed for prostate cancer or symptomatic benign prostatic disease, and for who a PSA assay is indicated.
  • Patients must have given informed consent.

Exclusion Criteria:

  • Patients followed for a disease other than prostatic.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rapid PSA assay on whole blood
Other: PSA assay
rapid prostate specific antigen assay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of the sensitivity and specificity of the rapid PSA assay by comparing the results obtained from the test strip reading by three independent blinded observers with those from standard plasma PSA assay.
Time Frame: day of test
day of test

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement.
Time Frame: at the last inclusion
at the last inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Principal Investigator: Dominique BELLET, Pr, Institut CURIE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 27, 2009

First Posted (Estimated)

March 2, 2009

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-A01497-48
  • CRH 08/459/MN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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