This randomized phase II trial studies the side effects of high-intensity aerobic or resistance exercise and to see how well it works in improving physical function and quality of life in patients with prostate cancer that has spread to other places in the body who are receiving standard hormonal therapy. An effective exercise program may improve the physical function and quality of life of patients with prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02613273.
PRIMARY OBJECTIVES:
I. Determine the safety, feasibility, and tolerance of a 12-week aerobic exercise program and 12- week resistance exercise program, among men with metastatic prostate cancer.
SECONDARY OBJECTIVES:
I. Determine the effect of a 12-week aerobic exercise program versus (vs.) a 12-week resistance exercise program vs. usual care on symptoms (e.g., cancer-related fatigue, pain), opiate use, physical function, and quality-of-life in men with metastatic castration-resistant prostate cancer (mCRPC).
EXPLORATORY OBJECTIVES:
I. Archive blood and urine for future exploratory studies.
II. Determine the effect of a 12-week aerobic program vs. a 12-week resistance exercise program vs. usual care on a validated prognostic score in men with mCRPC.
III. Determine the effect of a 12-week aerobic program vs. a 12-week resistance exercise program vs. usual care on disease progression, death, and symptomatic skeletal related events using additional follow-up data at year 1 and 2.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM A: Patients undergo structured aerobic training over 1 hours 3 times per week for 12 weeks.
ARM B: Patients undergo structured resistance training over 1 hour 3 times per week for 12 weeks.
ARM C: Patients undergo usual exercise and lifestyle routines.
After completion of study, patients are followed up at 6 months, 1 year, and 2 years.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUCSF Medical Center-Mount Zion
Principal InvestigatorStacey Kenfield