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

NCT ID: NCT02481648

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Vancouver Prostate Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Black, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Urologic Sciences, University of British Columbia

Locations

Vancouver Prostate Centre

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 34608048 (View on PubMed)

Other Identifiers

EMMPC

Identifier Type: -

Identifier Source: org_study_id