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

NCT02481648 | Unknown

• 1 other identifier: EMMPC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (11)

• Physical Fitness: Godin Leisure-Time Exercise questionnaire (GLTEQ) and activity logs

  Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery

• Physical Fitness: Anthropometrics (i.e. BMI & waist circumference)

  Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery

• Physical Fitness: Aerobic fitness using a submaximal graded exercise test

  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

  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

  Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery

Study Arms (2)

ARM1: Exercise Intervention

EXPERIMENTAL

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

ARM2: Control Group

NO INTERVENTION

Participants will be asked to exercise as they normally would and will be asked to record their exercise activity on provided activity logs.

Interventions

Exercise OTHER

ARM1: Exercise Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vancouver Prostate Centre: lead

Study Sites (1)

Vancouver Prostate Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (1)

• 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.

  PMID: 34608048 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Peter Black, MD

  Department of Urologic Sciences, University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: June 25, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

CA (1)