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

• ClinicalTrials.gov Identifier: NCT02481648
• Recruitment Status: Active, not recruiting
• First Posted: June 25, 2015
• Last Update Posted: April 19, 2023
• Sponsor: Vancouver Prostate Centre
• Information provided by (Responsible Party): Vancouver Prostate Centre

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Other: Exercise	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: July 2015
• Actual Primary Completion Date: December 2018
• Estimated Study Completion Date: December 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Physical Fitness: Godin Leisure-Time Exercise questionnaire (GLTEQ) and activity logs [ Time Frame: 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
2. Physical Fitness: Anthropometrics (i.e. BMI & waist circumference) [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
   Comparison of baseline versus end of study anthropometrics
3. Physical Fitness: Aerobic fitness using a submaximal graded exercise test [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
   Comparison of baseline versus end of study aerobic fitness
4. Physical Fitness: Functional fitness using the 30-second chair stand and 30-second arm curl [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
   Comparison of baseline versus end of study functional fitness
5. Physical Fitness: Muscular strength test upper and lower extremity using the 1RM [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
   Comparison of baseline versus end of study muscular strength
6. Physical Fitness: Blood pressure and pulse [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
   Comparison of baseline versus end of study blood pressure and pulse
7. Biological: Collection of urine, blood, biopsy and RP specimens [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
   Ability to collect these samples for each participant will be assessed
8. Psychosocial: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P) [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
   Comparison of questionnaire scores at baseline versus end of study
9. Psychosocial: Centre for Epidemiologic Studies Depression scale (CES-D) [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
   Comparison of questionnaire scores at baseline versus end of study
10. Psychosocial: International Prostate Symptom Score (IPSS) [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Comparison of questionnaire scores at baseline versus end of study
11. Psychosocial: International Index of Erectile Function scale (IIEF) [ Time Frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery ]
    Comparison of questionnaire scores at baseline versus end of study

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Canada, British Columbia

Vancouver Prostate Centre

Vancouver, British Columbia, Canada, V5Z 1M9

Sponsors and Collaborators

Vancouver Prostate Centre

Investigators

• Principal Investigator: Peter Black, MD; Department of Urologic Sciences, University of British Columbia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Vancouver Prostate Centre
• ClinicalTrials.gov Identifier: NCT02481648
• Other Study ID Numbers: EMMPC
• First Posted: June 25, 2015
• Last Update Posted: April 19, 2023
• Last Verified: April 2023

Additional relevant MeSH terms:

Prostatic Neoplasms; Disease Progression; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes