Prostate Cancer
Conditions
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.
Interventions
OTHERExercise
Sponsors
Vancouver Prostate Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Physical Fitness: Godin Leisure-Time Exercise questionnaire (GLTEQ) and activity logs | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | Comparison of activity at baseline, during the study and at the end of the study |
| Physical Fitness: Anthropometrics (i.e. BMI & waist circumference) | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | Comparison of baseline versus end of study anthropometrics |
| Physical Fitness: Aerobic fitness using a submaximal graded exercise test | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | Comparison of baseline versus end of study aerobic fitness |
| 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 | Comparison of baseline versus end of study functional fitness |
| 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 | Comparison of baseline versus end of study muscular strength |
| Physical Fitness: Blood pressure and pulse | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | Comparison of baseline versus end of study blood pressure and pulse |
| Biological: Collection of urine, blood, biopsy and RP specimens | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | Ability to collect these samples for each participant will be assessed |
| Psychosocial: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P) | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | Comparison of questionnaire scores at baseline versus end of study |
| Psychosocial: Centre for Epidemiologic Studies Depression scale (CES-D) | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | Comparison of questionnaire scores at baseline versus end of study |
| Psychosocial: International Prostate Symptom Score (IPSS) | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | Comparison of questionnaire scores at baseline versus end of study |
| Psychosocial: International Index of Erectile Function scale (IIEF) | Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery | Comparison of questionnaire scores at baseline versus end of study |
Countries
Canada
Outcome results
None listed