Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

Study Overview
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Brief Summary
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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.

Official Title
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Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

Conditions
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Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination

Intervention / Treatment
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* Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Results of urinary PCA3 test will be available<br>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 | Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)<br>* 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.<br>|
| Active Comparator: Results of urinary PCA3 test will not be available<br>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 | Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnosis, prostate cancer, urine, medical economics