The purpose of this study is to determine whether a 12-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among men with prostate cancer at high-risk of progression undergoing active surveillance.
The name of the study intervention involved in this study is:
Aerobic high-intensity interval training (HIIT) (training exercise intervention)
Age ≥18 years.
Histologically diagnosed with localized prostate cancer.
Initiating or undergoing active surveillance.
Having a higher risk of progression, defined as meeting one or more of the following: (1) favorable- intermediate risk prostate tumor at diagnosis, (2) obesity (body mass index ≥ 30), and/or (3) self- identified as Black or African American.
Received any invasive curative-intent treatment for prostate cancer, including surgery, chemotherapy, radiation therapy, and hormonal therapy.
Patients with metastasis and/or other active malignancies (except basal cell carcinoma) and/or receiving treatment for those malignancies.
Participating in any (>0 min/week) high-intensity exercise at the time of recruitment.
Having chronic medical conditions that are clinically unstable or uncontrolled with medications, deemed high-risk for exercise. These include but are not limited to unstable cardiac diseases, uncontrolled diabetes, and bone metastases with imminent risk of fracture.
Parallel
High-Intensity Interval Training Exercise Program
BehavioralHome-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor.
High-Intensity Interval Training Exercise Program
Behavioral(Optionally) Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor.
Prostate-Specific Antigen (PSA) Level
The primary outcome is the between-group difference in prostate-specific antigen (PSA) levels post-intervention. Analysis of covariance will be used to detect the difference adjusting for baseline values of the outcome and other covariates.
Prostate-Specific Antigen (PSA) Velocity
PSA velocity will be calculated following the PSA Working Group Guidelines, using the three most recent PSA values obtained from the medical chart with the first and last values being at least three months apart. The formula was based on the natural logarithm of 2 (0.693) divided by the slope obtained from fitting a linear regression of the natural log of PSA.
Prostate-Specific Antigen (PSA) Doubling Time
PSA doubling time will be calculated following the PSA Working Group Guidelines, using the three most recent PSA values obtained from the medical chart with the first and last values being at least three months apart. PSA velocity will be used to calculate the number of years that PSA levels become doubles, where the longer the time the better the prognosis.
Proliferation of LNCaP Prostate Cancer Cell Line
LNCaP cells are androgen-sensitive human prostate adenocarcinoma cells. LNCaP cells will be grown in vitro and their growth rate will be measured by counting the number of cells over time.
Cardiorespiratory Fitness
Cardiorespiratory fitness will be assessed as VO2peak by a graded maximal or submaximal cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged among every 30-second interval during the test. VO2peak will be reported in both relative (ml·kg-1·min-1) and absolute (L/min) terms.
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Fred Hutchinson Cancer Center
Lead sponsor
Prostate Cancer Foundation
Collaborator
