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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Vancouver Prostate Centre
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Feasibility: Treatment-specific retention rates
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Men with a medical, musculoskeletal condition or use of mobility aid that prevents participation in the exercise intervention.
Outcomes
Primary Outcomes
Feasibility: Treatment-specific retention rates
Time Frame: 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
Time Frame: From start of recruitment to end of recruitment
Feasibility: Proportion of planned assessments that are completed respectively
Time Frame: From date of randomization to end of study for each participant, an average of 7 months
Feasibility: Number of patients screened per month
Time Frame: From start of recruitment to end of recruitment
Feasibility: Number of patients enrolled per month
Time Frame: From start of recruitment to end of recruitment
Feasibility: Rates of adherence to protocol for the exercise intervention arm and control arm
Time Frame: From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks
Secondary Outcomes
- 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)