A Pilot Study to Evaluate Feasibility of Measuring Exercise's Effects on Molecular Mechanisms of Disease Progression in Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility: Treatment-specific retention rates
研究概览
简要总结
The investigators aim to evaluate the feasibility of a larger clinical trial assessing an exercise program during the "teachable moment" in patients with prostate cancer and measuring its effect on tumor apoptosis signaling, lipogenesis and steroidogenesis. Participants will be randomized between a 4-12 week exercise program or to standard of care only. Participants will be assessed at screening, baseline (day 0), throughout the trial intervention (days 1-84), post-intervention visit (prior to radical prostatectomy) and final study visit 6-months post-radical prostatectomy. At each assessment, physical, biological samples and psychosocial assessments will take place.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Completed Pre-Screening Consent Form
- •Men with CaP, who are deemed suitable by a urologist for RP
- •Engaging in <90 minutes/week of moderate-to-vigorous exercise
- •Able to speak and read English (to be able to complete questionnaires)
- •Willing to comply with all study procedures (including committing to twice-weekly visits to the study exercise facility and exercise at home) and be available for the duration of the study
- •Provide signed and dated informed consent form
排除标准
- •Men with a medical, musculoskeletal condition or use of mobility aid that prevents participation in the exercise intervention.
结局指标
主要结局
Feasibility: Treatment-specific retention rates
时间窗: From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks
Feasibility: Proportion of screen eligible patients who enroll
时间窗: From start of recruitment to end of recruitment
Feasibility: Proportion of planned assessments that are completed respectively
时间窗: From date of randomization to end of study for each participant, an average of 7 months
Feasibility: Number of patients screened per month
时间窗: From start of recruitment to end of recruitment
Feasibility: Number of patients enrolled per month
时间窗: From start of recruitment to end of recruitment
Feasibility: Rates of adherence to protocol for the exercise intervention arm and control arm
时间窗: From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks
次要结局
- Physical Fitness: Anthropometrics (i.e. BMI & waist circumference)(Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery)
- Physical Fitness: Muscular strength test upper and lower extremity using the 1RM(Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery)
- Physical Fitness: Blood pressure and pulse(Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery)
- Psychosocial: International Index of Erectile Function scale (IIEF)(Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery)
- Physical Fitness: Godin Leisure-Time Exercise questionnaire (GLTEQ) and activity logs(Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery)
- Physical Fitness: Functional fitness using the 30-second chair stand and 30-second arm curl(Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery)
- Physical Fitness: Aerobic fitness using a submaximal graded exercise test(Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery)
- Biological: Collection of urine, blood, biopsy and RP specimens(Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery)
- Psychosocial: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P)(Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery)
- Psychosocial: Centre for Epidemiologic Studies Depression scale (CES-D)(Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery)
- Psychosocial: International Prostate Symptom Score (IPSS)(Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery)