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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver Prostate Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM1: Exercise Intervention; 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
No Intervention: ARM2: Control Group; 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?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Vancouver Prostate Centre

Publications and helpful links

General Publications

• Schulz GB, Locke JA, Campbell KL, Bland KA, Van Patten CL, Black PC, Goldenberg SL, Flannigan R. Taking Advantage of the Teachable Moment at Initial Diagnosis of Prostate Cancer-Results of a Pilot Randomized Controlled Trial of Supervised Exercise Training. Cancer Nurs. 2022 May-Jun 01;45(3):E680-E688. doi: 10.1097/NCC.0000000000001013. Epub 2022 Jan 14.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: June 24, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Disease Progression; Prostatic Neoplasms
• Other Study ID Numbers: EMMPC