Test Semiquantitative Prostate Specific Antigen (PSA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer Prostatic Neoplasms Prostatic Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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rapid PSA assay on whole blood

Group Type EXPERIMENTAL

PSA assay

Intervention Type OTHER

rapid prostate specific antigen assay.

Interventions

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PSA assay

rapid prostate specific antigen assay.

Intervention Type OTHER

Eligibility Criteria

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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.