From PSA to Stockholm3, a Naturalistic Effectiveness Multipart Research Program: Study Part 1
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 13,431
- 试验地点
- 1
- 主要终点
- Rate of prostate cancer with Gleason score ≥ 7 / Gleason score ≤ 6
研究概览
简要总结
This part of the project aims to analyze the effectiveness of the Stockholm3 test in regular clinical practice, both in general practice and in the specialist health care, as a tool for detecting patients who need further diagnostics for prostate cancer.
详细描述
Background:
Prostate cancer constitutes about 15 % of new cases of cancer among men globally, but about 27 % of all new cases of cancer in men in Norway. It is also the leading cause of cancer death among men, and nearly 1100 Norwegian men died from prostate cancer in 2014. However, only about 30 percent of new cases have an aggressive form of the disease. Therefore, the challenge is to detect and distinguish patients with aggressive disease from patients who have a low risk cancer.
The Prostate-Specific Antigen (PSA) is currently the main test used in primary care to detect and prioritize patients for further diagnostics. PSA is used for screening in many countries, but the Norwegian authorities consider the harms of using PSA for screening purposes (over-diagnosis and overtreatment) to outweigh the benefits (potentially reduced mortality). Nevertheless, it has been documented that a substantial amount of opportunistic PSA screening takes place in Norway.
At present, a novel test called the Stockholm3 test has been developed. A large prospective study has shown that the efficacy of the Stockholm3 test is superior to PSA, and both the sensitivity and the specificity are substantially higher for Stockholm3 than for PSA.
Aim The aim of this study is to analyze the effectiveness of the Stockholm3 test in regular clinical practice, including both primary care and specialized health care.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All men where a physicians in regular clinical work finds that there is an indication to take the test
排除标准
- •known prostate cancer
结局指标
主要结局
Rate of prostate cancer with Gleason score ≥ 7 / Gleason score ≤ 6
时间窗: 9 to 12 months from september 2017 compared with a corresponding period one year earlier
The percentage of patients whose prostate biopsies showed a Gleason score ≤ 6 or ≥7 among those referred for diagnostics based on a PSA test or a Stockholm3 test
次要结局
- Rate of prostate biopsies among patients tested with PSA and Stockholm3(9 to 12 months from september 2017 compared with a corresponding period one year earlier)