NCT00853710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

February 24, 2009

Last Update Submit

November 19, 2025

Conditions

Prostate CancerProstatic NeoplasmsProstatic Diseases

Keywords

Prostate-Specific AntigenProstate CancerCancerAssay

Outcome Measures

Primary Outcomes (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.

    day of test

Secondary Outcomes (1)

  • Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement.

    at the last inclusion

Study Arms (1)

rapid PSA assay on whole blood

EXPERIMENTAL
Other: PSA assay

Interventions

PSA assayOTHER

rapid prostate specific antigen assay.

rapid PSA assay on whole blood

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients followed for prostate cancer or symptomatic benign prostatic disease, and for who a PSA assay is indicated.
  • Patients must have given informed consent.

You may not qualify if:

  • Patients followed for a disease other than prostatic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

MeSH Terms

Conditions

Prostatic NeoplasmsProstatic DiseasesNeoplasms

Interventions

Prostate-Specific Antigen

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

KallikreinsSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesProstatic Secretory ProteinsSeminal Plasma ProteinsSeminal ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigens, NeoplasmAntigensBiological FactorsBiomarkers, TumorBiomarkers

Study Officials

  • Dominique BELLET, Pr

    Institut Curie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2009

First Posted

March 2, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations

FR(1)