SPCG17: Prostate Cancer Active Surveillance Trigger Trial (PCASTT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 23
- 主要终点
- Progression-free survival
研究概览
简要总结
A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative treatment only when and if signs of tumor progression occur. There are however a number of uncertainties in AS, the most important being when to initiate treatment. The investigators are therefore starting a large randomized multicenter trial testing the safety of a standardized active surveillance protocol with specified triggers for repeat biopsies and initiation of curative treatment. The standardized protocol is compared with current practice for active surveillance. The primary aim of the study is to reduce overtreatment and subsequent side effects, without increasing the risk of disease progression or prostate cancer mortality.
详细描述
STUDY HYPOTHESIS
The study hypothesis is that standardized triggers for initiation of curative treatment of men who are in active surveillance will reduce overtreatment without increasing disease progression and prostate cancer mortality.
STUDY DESIGN
Randomized multi-centre open-label clinical trial
INTERVENTIONS
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Recently (within 12 months) diagnosed adenocarcinoma of the prostate
- •Tumor stage less than or equal to T2a, NX, M0
- •PSA less than 15 ng/ml, PSA density less than or equal to 0.20 ng/ml/cc
- •Gleason pattern 3+3=6 (any number of cores, any cancer involvement)
- •Gleason pattern 3+4=7 (less than 3 cores (or less than 30% of cores if more than 10 cores are taken), less than 10 mm cancer in one core)
- •Life expectancy more than 10 years with no upper age limit
- •Candidate for curative treatment if progression occurs
- •Signed written informed consent
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
时间窗: Median 10 years follow-up
Disease progression is defined as 1) cumulative incidence of PSA relapse after curative treatment or 2) cumulative incidence of androgen deprivation therapy in untreated men still in active surveillance.
次要结局
- Cumulative incidence of metastases(Median 10 years follow-up)
- Cumulative number of treatments with curative intent (mainly radical prostatectomies or local radiotherapy)(Median 10 years follow-up)
- Quality of life(Median 10 years follow-up)
- Cumulative incidence of pT3(Median 10 years follow-up)
- Cumulative incidence of switch to watchful waiting(Median 10 years follow-up)
- Prostate cancer mortality(Median 10 years follow-up)
研究者
Anna Bill-Axelson
Professor
Uppsala University