Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 962
- 试验地点
- 17
- 主要终点
- Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients ≥ 18 year-old
- •patients who undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination
- •patients who gave informed consent
排除标准
- •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)
结局指标
主要结局
Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point
时间窗: 24 months
次要结局
- 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)