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

Prostate Cancer Clinical Trial

— EMMPC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02481648
• Other study ID #: EMMPC
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Vancouver Prostate Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease Progression
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Exercise

Locations

Country	Name	City	State
Canada	Vancouver Prostate Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Vancouver Prostate Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Number of patients screened per month		From start of recruitment to end of recruitment
Primary	Feasibility: Number of patients enrolled per month		From start of recruitment to end of recruitment
Primary	Feasibility: Proportion of screen eligible patients who enroll		From start of recruitment to end of recruitment
Primary	Feasibility: Treatment-specific retention rates		From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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