Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal ExaminationNCT01632930
Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis
A study testing urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe) in people with Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination, run by Hospices Civils de Lyon at 10 sites in France.
Trial summary
The ultrasound-guided biopsies of the prostate is the validated technique for the diagnosis of prostate cancer, the first human cancer and second leading cause of cancer death. Overall, in more than half of cases, prostate biopsies performed in search of a prostate cancer are negative. Read more about this study
- Who is it for?
- Ages 18 months and older, men only
- Conditions the study is for
- Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination
- What is being tested?
- urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 962 participants
- Where
- 10 sitesFrance
- Study dates
- 2 Jul 2012to 26 Apr 2021
- 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 months and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients ≥ 18 year-old
- patients who undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination
- patients who gave informed consent
Who cannot join
- no informed consent
- medical history of or current significant prostate cancer
- medical history of or current extra-prostatic cancer
- high risk of loss of follow-up
- clinically obvious prostate cancer (clinical stage ≥ T3, PSA ≥ 50 ng/ml, lymph node involvement, osteolytic bone metastases)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Angers
Angers, 49933
Centre Hospitalier Alpes Leman
Contamine-sur-Arve
Hôpital du Bocage
Dijon, 21079
Hôpital Edouard Herriot
Lyon
Hôpital Pitié-Salpêtrière,
Paris, 75013
Hôpital Tenon
Paris, 75020
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Hôpital de la Milétrie
Poitiers, 86000
Centre hospitalier de Thonon les bains
Thonon-les-Bains
Centre Hospitalier de Valence
Valence
About this study
The ultrasound-guided biopsies of the prostate is the validated technique for the diagnosis of prostate cancer, the first human cancer and second leading cause of cancer death. Overall, in more than half of cases, prostate biopsies performed in search of a prostate cancer are negative. In this population, there is no consensus recommendation on how to care, leading to repeated invasive biopsies, potential sources of complications.
The PCA3 urine test (ProgensaTM, GenProbe) is an innovative diagnostic tool to predict the positivity of prostate biopsies, especially in patients who had at least one negative biopsy. Proposed in clinical practice in France as a commercial kit, it is expensive and is not covered by health insurance. It is therefore essential to assess the medical and economic impact of its introduction into medical practice.
The investigators propose to set up a study of high standard of proof, multicenter, based on recruitment of patients treated in hospitals. This working hypothesis is that the availability of the PCA3 test results would reduce the number of invasive biopsies performed incorrectly in patients already had at least one negative biopsy, thus improving the diagnostic strategy of prostate cancer.
- Being tested
- urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)
- Keywords
- diagnosis, prostate cancer, urine, medical economics
- Medical subject headings
- Disease, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)Other
urinary PCA3 test will be performed in patients before they undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination. Patients with negative biopsies will be definitively enrolled in the study. The physician in charge will have knowledge of PCA3 test results and will be asked to determine the subsequent follow-up taking these results into account.
| Study group | Role | What they receive |
|---|---|---|
| Results of urinary PCA3 test will be available | Experimental | In this arm, physicians will have knowledge of urinary PCA3 test results. How they subsequently manage patients with prostate cancer suspicion is likely to be influenced by urinary PCA3 test results Receives: Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe) |
| Results of urinary PCA3 test will not be available | Active comparator | In this arm, physicians will not have knowledge of urinary PCA3 test results. How they subsequently manage patients with prostate cancer suspicion will therefore not be influenced by urinary PCA3 test results Receives: Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point
Measured: 24 months
Secondary outcomes (3)
Medical impact of availability of PCA3 test results
To determine whether availability of PCA3 test results influences patient management in terms of physical examinations, , PSA testing, prostate ultrasonography, prostate MRI and delay in performing these tests
Measured: 12 months
Diagnostic performances of urinary PCA3 test
Intrinsic performances of PCA3 test in predicting prostate biopsy results in term of sensitivity, specificity and area under ROC curves
Measured: 12, 24 and 60 months
Cost-efficiency study
To determine how availability of PCA3 test results alters medical economics when managing patients with prostate cancer suspicion
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study start2 Jul 2012
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal ExaminationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 962 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632930
- Sponsor's protocol ID
- 2011.660
- Status last verified
- Feb 2022
- First submitted
- 29 Jun 2012
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT01632930
- Acronym / sponsor ID
- 2011.660
- Keywords
- diagnosis, prostate cancer, urine, medical economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 962 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Jul 2012 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 3 Jul 2012 (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 ultrasound-guided biopsies of the prostate is the validated technique for the diagnosis of prostate cancer, the first human cancer and second leading cause of cancer death. Overall, in more than half of cases, prostate biopsies performed in search of a prostate cancer are negative. In this population, there is no consensus recommendation on how to care, leading to repeated invasive biopsies, potential sources of complications.
The PCA3 urine test (ProgensaTM, GenProbe) is an innovative diagnostic tool to predict the positivity of prostate biopsies, especially in patients who had at least one negative biopsy. Proposed in clinical practice in France as a commercial kit, it is expensive and is not covered by health insurance. It is therefore essential to assess the medical and economic impact of its introduction into medical practice.
The investigators propose to set up a study of high standard of proof, multicenter, based on recruitment of patients treated in hospitals. This working hypothesis is that the availability of the PCA3 test results would reduce the number of invasive biopsies performed incorrectly in patients already had at least one negative biopsy, thus improving the diagnostic strategy of prostate cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Results of urinary PCA3 test will be available | Experimental | Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)In this arm, physicians will have knowledge of urinary PCA3 test results. How they subsequently manage patients with prostate cancer suspicion is likely to be influenced by urinary PCA3 test results |
| Results of urinary PCA3 test will not be available | Active comparator | Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)In this arm, physicians will not have knowledge of urinary PCA3 test results. How they subsequently manage patients with prostate cancer suspicion will therefore not be influenced by urinary PCA3 test results |
Who may qualify
- Ages
- 18 months and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients ≥ 18 year-old
- patients who undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination
- patients who gave informed consent
Key exclusion criteria (5 listed)
- no informed consent
- medical history of or current significant prostate cancer
- medical history of or current extra-prostatic cancer
- high risk of loss of follow-up
- clinically obvious prostate cancer (clinical stage ≥ T3, PSA ≥ 50 ng/ml, lymph node involvement, osteolytic bone metastases)
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 |
|---|---|---|
| urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)urinary PCA3 test will be performed in patients before they undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination. Patients with negative biopsies will be definitively enrolled in the study. The physician in charge will have knowledge of PCA3 test results and will be asked to determine the subsequent follow-up taking these results into account. | Other | Results of urinary PCA3 test will be available, Results of urinary PCA3 test will not be available |
Primary outcome
Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point
Time frame: 24 months
3 secondary outcomes
Medical impact of availability of PCA3 test results
Time frame: 12 months
Diagnostic performances of urinary PCA3 test
Time frame: 12, 24 and 60 months
Cost-efficiency study
Time frame: 24 months
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 3 Feb 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe) in people with Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination, run by Hospices Civils de Lyon at 10 sites 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 3 inclusion and 5 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 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point (time frame: 24 months). 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 3 Feb 2022.