The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 82,849
- 试验地点
- 8
- 主要终点
- Disease specific mortality
研究概览
简要总结
RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor may not need treatment until it progresses. In this case, active surveillance may be sufficient. It is not yet known which treatment regimen is more effective for localized prostate cancer.
PURPOSE: This randomized phase III trial is studying active monitoring to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.
详细描述
OBJECTIVES:
- To assess survival of patients with localized prostate cancer at 10 years and 15 years after treatment.
- To investigate disease progression (i.e., biochemical and clinical), treatment complications, and lower urinary tract symptoms in these patients.
- To investigate the psychosocial impact of cancer detection and treatment on these patients, including generic health status, quality of life, and sexual function.
- To estimate the resource use and costs of detection, treatment, and follow-up.
- To compare costs and outcomes of treatment in terms of survival and health-related quality of life.
- To collect samples suitable for basic science research (ProMPT study).
OUTLINE: This is a multicenter study. Patients are stratified by age (50-55 vs 56-59 vs 60-65 vs 66-69 years), Gleason score (6, 7, 8-10), and average result of recruitment and first biopsy prostate-specific antigen (PSA) tests (< 6 vs 6-9.9 vs ≥ 10 ng/mL). Patients are randomized or select a treatment to be followed up in a cohort study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Fit for the treatments and estimates life expectancy of 10 years Registration with eligible primary care practice
排除标准
- •Unable to give written informed consent. Concomitant or past malignancy.
结局指标
主要结局
Disease specific mortality
时间窗: Median 15 years follow up
次要结局
- Sexual function(Median 15years)
- Overall survival(Median 15 years)
- Disease progression(Median 15 years)
- Treatment complications(Median 15 years)
- General health status(Median 15 years)
- Psychological state(Median 15 years)
- Symptoms(Median 15 years)