Test Semiquantitative Prostate Specific Antigen (PSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00853710
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : August 28, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostatic Neoplasms Prostatic Diseases Other: PSA assay Not Applicable

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  (Clinical Trial)
Actual Enrollment : 94 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of a Semiquantitative Screening Assay for PSA
Study Start Date : March 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement. [ Time Frame: at the last inclusion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00853710

Centre Rene Huguenin
Saint Cloud, France, 92210
Sponsors and Collaborators
Institut Curie
Principal Investigator: Dominique BELLET, Pr Institut Curie

Responsible Party: Institut Curie Identifier: NCT00853710     History of Changes
Other Study ID Numbers: ID RCB 2008-A01497-48
CRH 08/459/MN
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017

Keywords provided by Institut Curie:
Prostate-Specific Antigen
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male