Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 962
- Locations
- 17
- Primary Endpoint
- Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Months to — (Child, Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point
Time Frame: 24 months
Secondary Outcomes
- Cost-efficiency study(24 months)
- Medical impact of availability of PCA3 test results(12 months)
- Diagnostic performances of urinary PCA3 test(12, 24 and 60 months)