Test Semiquantitative Prostate Specific Antigen (PSA)

Not Applicable

Completed

• Conditions: Prostate Cancer; Prostatic Neoplasms; Prostatic Diseases
• Interventions: Other: PSA assay

• Registration Number: NCT00853710
• Lead Sponsor: Institut Curie

Brief Summary

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.

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 Timeline

• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-27
• Study Start: 2009-03
• Study First Posted: 2009-03-02
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rapid PSA assay on whole blood	PSA assay	-

Primary Outcome Measures

Name	Time	Method
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.	day of test

Secondary Outcome Measures

Name	Time	Method
Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement.	at the last inclusion

Trial Locations

Locations (1)

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France