This phase II trial tests the effect of exercise therapy on the features of progression in men diagnosed with prostate cancer that has not spread to other sites (localized) and are undergoing active surveillance. Almost 50% of men diagnosed with prostate cancer with low -grade, low-volume (low-risk) disease are on active surveillance, however, around 30% of these men will progress within 2 years of follow-up. Effective, low cost strategies are needed to lower the risk of progression of prostate cancer during active surveillance. Studies have shown that exercise can prevent or slow the growth of tumors in people with low-risk prostate cancer, however, the effect of exercise on the signs of progression (indicators) in prostate cancer in patients undergoing active surveillance has not been studied. Indicators of prostate cancer may include certain changes (mutations) in cells, low levels of oxygen in body tissues (hypoxia), and the ability to see tumors on radiologic scans, among others. This study may allow researchers to find out the effects of exercise therapy on various indicators of prostate cancer and whether exercise works against the growth and spread of prostate cancer in people who are on active surveillance.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05751434.
PRIMARY OBJECTIVE:
I. To determine the effects of exercise therapy on molecular, radiologic, and pathologic nimbosus hallmarks versus usual care control in men on active surveillance (AS) for localized prostate cancer.
SECONDARY OBJECTIVES:
I. To evaluate exercise safety and tolerability.
II. To explore the pharmacodynamics of exercise therapy as evaluated by changes in physiological end points (e.g., exercise capacity, body composition, blood pressure, heart rate).
III. To compare patient-reported outcomes.
EXPLORATORY OBJECTIVES:
I. To delineate the precision of estimating rates of clinical progression at 18 months.
II. To compare time to clinical progression and treatment-free percentage between the exercise and usual care groups.
III. To compare change in individual nimbosus hallmarks between the exercise and usual care groups.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo consultation with exercise physiologist, undergo treadmill exercise tolerance testing and participate in prescribed supervised exercise therapy sessions over 10-70 minutes each 5 times per week for about 6-12 months. Patients undergo biopsy with multiparametric magnetic resonance imaging (mpMRI) at baseline and follow up and blood collection at baseline and with study related assessments.
ARM II: Patients undergo consultation with exercise physiologist and participate in home-based aerobic walking program over 150 minutes weekly with periodic coaching for about 6-12 months. Patients undergo biopsy with mpMRI at baseline and follow up and blood collection at baseline and with study related assessments.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJessica Scott
