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

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT02481648
• Lead Sponsor: Vancouver Prostate Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-25
• Study Start: 2015-07
• Primary Completion: 2018-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

• Men with a medical, musculoskeletal condition or use of mobility aid that prevents participation in the exercise intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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: Proportion of planned assessments that are completed respectively	From date of randomization to end of study for each participant, an average of 7 months
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: 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

Secondary Outcome Measures

Name	Time	Method
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: 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
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
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: 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: 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
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

Trial Locations

Locations (1)

Vancouver Prostate Centre; 🇨🇦 Vancouver, British Columbia, Canada