Prostate CancerNCT00853710
Test Semiquantitative Prostate Specific Antigen (PSA)
A study testing PSA assay in people with Prostate Cancer and Prostatic Neoplasms, run by Institut Curie at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasms, Prostatic Diseases
- What is being tested?
- PSA assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients followed for prostate cancer or symptomatic benign prostatic disease, and for who a PSA assay is indicated.
- Patients must have given informed consent.
Who cannot join
- Patients followed for a disease other than prostatic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Semiquantitative Screening Assay for PSA
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.
Read the 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.
- Conditions
- Prostate Cancer, Prostatic Neoplasms, Prostatic Diseases
- Being tested
- PSA assay
- Keywords
- Prostate-Specific Antigen, Prostate Cancer, Cancer, Assay
- Medical subject headings
- Prostatic Neoplasms, Prostatic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSA assayOther
rapid prostate specific antigen assay.
| Study group | Role | What they receive |
|---|---|---|
| rapid PSA assay on whole blood | Experimental | Not described Receives: Other: PSA assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day of test
Secondary outcomes (1)
Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement.
Measured: at the last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique BELLET, Pr, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853710
- Sponsor's protocol ID
- 2008-A01497-48
- Other IDs
- CRH 08/459/MN
- Status last verified
- Nov 2025
- First submitted
- 24 Feb 2009
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Semiquantitative Screening Assay for PSA
- ClinicalTrials.gov ID
- NCT00853710
- Acronym / sponsor ID
- 2008-A01497-48
- Conditions
- Prostate Cancer, Prostatic Neoplasms, Prostatic Diseases
- Keywords
- Prostate-Specific Antigen, Prostate Cancer, Cancer, Assay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rapid PSA assay on whole blood | Experimental | Other: PSA assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients followed for prostate cancer or symptomatic benign prostatic disease, and for who a PSA assay is indicated.
- Patients must have given informed consent.
Key exclusion criteria (1 listed)
- Patients followed for a disease other than prostatic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSA assayrapid prostate specific antigen assay. | Other | rapid PSA assay on whole blood |
Primary outcome
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
1 secondary outcome
Determination of the threshold which maximizes the performance of the semiquantitative test. Determination of interobserver agreement.
Time frame: at the last inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique BELLET, Pr principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSA assay in people with Prostate Cancer and Prostatic Neoplasms, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.