Test Semiquantitative Prostate Specific Antigen (PSA)

Validation of a Semiquantitative Screening Assay for PSA

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00853710

Enrollment

Registered

2009-03-02

Start date

2009-03-31

Completion date

2009-07-31

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Prostatic Diseases, Prostatic Neoplasms

Keywords

Prostate-Specific Antigen, Prostate Cancer, Cancer, Assay

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.

Interventions

OTHERPSA assay

rapid prostate specific antigen assay.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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.	day of test

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026