Feasibility of Measuring Exercise's Effects on Molecular Mechanisms of Disease Progression in Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 BMI <40 Age >19 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 Exclusion Criteria: • Men with a medical, musculoskeletal condition or use of mobility aid that prevents participation in the exercise intervention.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM1: Exercise Intervention<br>The exercise program is a 4-12 weeks progressive combined resistance and aerobic exercise for participants from time of diagnosis to RP. Participants will undergo twice weekly group-training (four-six participants/group) combined aerobic-resistance sessions (1hr per session), supervised by trained exercise therapists. In addition, participants will undergo home-based aerobic exercise independently three times a week with the goal to meet the current physical activity guidelines for cancer survivors (150min/week of moderate intensity aerobic activity and two resistance training sessions per week). Participants will also be supplied with the Canadian Physical Activity and Sedentary Behavior Guidelines Handbook and accompanying Log Sheets. | Other: Exercise<br> <br> |
| No Intervention: ARM2: Control Group<br>Participants will be asked to exercise as they normally would and will be asked to record their exercise activity on provided activity logs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Number of patients screened per month |  | From start of recruitment to end of recruitment | 
| Feasibility: Number of patients enrolled per month |  | From start of recruitment to end of recruitment | 
| Feasibility: Proportion of screen eligible patients who enroll |  | From start of recruitment to end of recruitment | 
| Feasibility: Treatment-specific retention rates |  | From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks | 
| Feasibility: Rates of adherence to protocol for the exercise intervention arm and control arm |  | From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks | 
| Feasibility: Proportion of planned assessments that are completed respectively |  | From date of randomization to end of study for each participant, an average of 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Fitness: Godin Leisure-Time Exercise questionnaire (GLTEQ) and activity logs | Comparison of activity at baseline, during the study and at the end of the study | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | 
| Physical Fitness: Anthropometrics (i.e. BMI & waist circumference) | Comparison of baseline versus end of study anthropometrics | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | 
| Physical Fitness: Aerobic fitness using a submaximal graded exercise test | Comparison of baseline versus end of study aerobic fitness | 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 | Comparison of baseline versus end of study functional fitness | 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 | Comparison of baseline versus end of study muscular strength | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | 
| Physical Fitness: Blood pressure and pulse | Comparison of baseline versus end of study blood pressure and pulse | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | 
| Biological: Collection of urine, blood, biopsy and RP specimens | Ability to collect these samples for each participant will be assessed | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | 
| Psychosocial: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P) | Comparison of questionnaire scores at baseline versus end of study | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | 
| Psychosocial: Centre for Epidemiologic Studies Depression scale (CES-D) | Comparison of questionnaire scores at baseline versus end of study | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | 
| Psychosocial: International Prostate Symptom Score (IPSS) | Comparison of questionnaire scores at baseline versus end of study | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | 
| Psychosocial: International Index of Erectile Function scale (IIEF) | Comparison of questionnaire scores at baseline versus end of study | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery |