This pilot trial studies the impact of a home-based exercise program on prognostic biomarkers in participants with prostate cancer. Several reports suggest that physical activity after a cancer diagnosis is associated with better cancer-specific and overall survival in individuals diagnosed with prostate cancer. A home-based exercise program may help doctors to learn the impact of exercise on blood markers associated with tumor development and the effect of exercise on the biology of prostate cancer, its impact on fatigue, and quality of life in participants with prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03397030.
PRIMARY OBJECTIVE:
I. To demonstrate the impact of a home based exercise program versus wait-list control to modulate circulating prognostic biomarkers PSA, prostate-specific membrane antigen (PSMA), early prostate cancer antigen (EPCA), urokinase plasminogen activator (uPA) and urokinase plasminogen activator receptor (uPAR) in men with prostate cancer.
SECONDARY OBJECTIVE:
I. To demonstrate the capability of a home based exercise program versus wait-list control in improving physical function and body composition in men with prostate cancer.
OTHER OBJECTIVES:
I. To determine if circulating biomarkers are associated with physical function and body composition in men with prostate cancer.
II. To determine the impact of a home based exercise program versus wait-list control to modulate a novel salivary biomarker for fatigue in men with prostate cancer.
III. To determine changes in the gut microbiome in relation to tumor progression markers.
IV. To demonstrate the feasibility of conducting a home based exercise investigation.
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I (HOME-BASED EXERCISE PROGRAM): Participants participate in a home-based exercise program consisting of light-to-moderate walking over 30 minutes for 5 days a week for 24 weeks and body-weight exercises comprising 3 sets of 15 repetitions of bodyweight squats, incline push-ups, and hip thrusts or lower intensity exercises such as sit-to-stand, wall push up, and pelvic tilt, 3 days a week for 24 weeks.
GROUP II (WAITLIST-CONTROL): Participants maintain normal activity and visit the Cancer Therapy and Research Center (CTRC) fitness center for research appointments.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationCancer Therapy and Research Center at The UT Health Science Center at San Antonio
Principal InvestigatorDarpan Patel