Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer: the PANTERA Trial (Prostate cAncer Novel ThERApy)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility as measured by rate of recruitment
研究概览
简要总结
Study design: The study is a two arm randomised controlled trial (randomisation ratio 1:1) comparing an aerobic exercise training intervention to usual care plus exercise advice. The primary outcome is the feasibility of the intervention as novel primary therapy in men with localised 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
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •In accordance with NICE active surveillance guidelines, men:
- •Who have been evaluated using a combination of clinical, bio-chemical, imaging and/or biopsy, within the last 12 months
- •With histologically confirmed low or intermediate risk prostate cancer, Gleason score ≤7 (3+4, not 4+3)
- •With up to T2a clinical stage tumours
- •With pre-treatment PSA ≤20 ng/mL
- •Who are willing to participate in optimal active surveillance and provide written informed consent
- •With life expectancy of ≥10 years
排除标准
- •With unstable angina
- •With uncontrolled hypertension
- •With recent myocardial infarction (within the past 6 months)
- •With pacemakers
- •Already undertaking regular physical activity (greater than 90 minutes of moderate intensity exercise, per week) will be excluded
- •With any other physical or mental limitation preventing participation in trial assessments
- •Participating in other clinical trials which might bias the evaluation of the primary objectives of the present study
研究组 & 干预措施
Intervention
12 months of aerobic exercise training with behaviour change support
干预措施: Aerobic exercise training (Behavioral)
Comparison
Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer
干预措施: Placebo surveillance and written exercise guidelines (Behavioral)
结局指标
主要结局
Feasibility as measured by rate of recruitment
时间窗: 36 months
The rate of recruitment will be measured by comparing the number of patients screended to the number of patients recruited. This will allow us to asses if a future full-scale trial is feasible.
次要结局
- Feasibility as measured by Intervention adherence(36 months)