The purpose of this study is to determine whether a 16-week supervised, clinic-based circuit training intervention utilizing resistance and functional exercises and self-directed aerobic exercise will improve frailty and sarcopenic status and disease progression outcomes among pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy (ADT).
The names of the study intervention involved in this study is:
• Supervised circuit training (aerobic and resistance exercise regimen)
Ability to understand and the willingness to sign informed consent prior to any study-related procedures.
Diagnosed with metastatic prostate cancer.
Aged ≥18 years; due to the rarity of the disease in those <18 years, this age bracket will not be included.
Have been receiving androgen deprivation (either with or without androgen receptor targeted treatment) for at least one month and expect to remain on their treatment for at least 4 months.
Receiving chemotherapy. This study is exclusively targeting androgen deprivation therapy-related effects.
Have unstable bone lesions. In general patients with severely symptomatic/unstable bone lesions due to bone metastases are at a higher risk of fractures.
Complete 2 or more structured resistance exercise sessions per week over the last 4 months and participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the last month. Excess additional exercise is a confounding factor in assessing the effect of the current exercise program.
Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities likely require supervised exercise for safety, and part of this study involves unsupervised exercise; therefore, for safety reasons, these persons are excluded.
Parallel
Supervised Circuit Training
Behavioral16-week, multicomponent exercise intervention comprised of sessions supervised by certified exercise oncology trainer and home-based, self-directed aerobic exercises. Stationary bike and accelerometer (activity/heart rate monitor) will be provided.
Change in Circulating Inflammation for Exercise Group
Assessed by change in systemic inflammatory biomarkers through blood analysis (ul/ml).
Frailty
This will be assessed by the Fried Frailty Phenotype, which measures participant ratings on a five-characteristic scale and will be totaled for an overall frailty score of 1-2, identified as prefail, or ≥3, identified as frail. Participants will receive a score of 1 (experience characteristic) or 0 (do not experience) for each characteristic.
Sarcopenia
A sarcopenia score of ≤10.75 kg/m2, as assessed by computed tomography (CT), will be the cut point used for identifying muscle loss = 1 point.
Skeletal Muscle Biomarkers - myokines
Assessed from muscle biopsy specimens of the vastus lateralis (ul/ml).
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Dana-Farber Cancer Institute
Lead sponsor
Prostate Cancer Foundation
Collaborator
