An interventional study of PSA assay in Prostate Cancer, Prostatic Neoplasms and Prostatic Diseases, sponsored by Institut Curie. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Institut Curie · Not applicable, Interventional, and Diagnostic
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 94 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Institut Curie is the lead sponsor of 135 studies on the registry; 29 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: PSA assay
rapid prostate specific antigen assay.
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
Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement.
Time frame: at the last inclusion
The record gives a start of Mar 2009, a primary completion of Jul 2009 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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