Test Semiquantitative Prostate Specific Antigen (PSA)

Institut Curie

Status: Completed

Conditions: Prostatic Neoplasms; Prostatic Diseases; Prostate Cancer

Treatments: Other: PSA assay

Study type: Interventional

Funder types: Other

Identifiers

NCT00853710

2008-A01497-48

CRH 08/459/MN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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94 participants in 1 patient group

rapid PSA assay on whole blood

Experimental group

Treatment:

Other: PSA assay