Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Angers, France, 49933
- CHU Angers
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Contamine-sur-Arve, France
- Centre hospitalier Alpes Léman
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Dijon, France, 21079
- Hôpital du Bocage
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Lyon, France
- Hopital Edouard Herriot
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Paris, France, 75020
- Hôpital Tenon
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Paris, France, 75013
- Hôpital Pitié-Salpêtrière,
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Pierre Benite, France, 69495
- Centre hospitalier Lyon Sud
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Poitiers, France, 86000
- Hopital de la Milétrie
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Thonon Les Bains, France
- Centre hospitalier de Thonon les bains
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Valence, France
- Centre Hospitalier de Valence
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients ≥ 18 year-old
- patients who undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination
- patients who gave informed consent
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Results of urinary PCA3 test will be available
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
|
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.
|
|
Active Comparator: Results of urinary PCA3 test will not be available
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medical impact of availability of PCA3 test results
Time Frame: 12 months
|
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
|
12 months
|
|
Diagnostic performances of urinary PCA3 test
Time Frame: 12, 24 and 60 months
|
Intrinsic performances of PCA3 test in predicting prostate biopsy results in term of sensitivity, specificity and area under ROC curves
|
12, 24 and 60 months
|
|
Cost-efficiency study
Time Frame: 24 months
|
To determine how availability of PCA3 test results alters medical economics when managing patients with prostate cancer suspicion
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011.660
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