This trial studies how well a behavioral lifestyle intervention (EMPOWER) works in reducing prostate cancer progression in patients with prostate cancer who have increasing levels of prostate specific antigen (PSA) after surgery or radiation therapy (biochemically recurrent). The evidence suggests that even modest weight gain may be associated with an increased risk of prostate cancer recurrence, fatal prostate cancer, and prostate cancer-specific mortality after a diagnosis of prostate cancer. The biological reasons underlying the association between obesity and prostate cancer development have not been established. Despite the observed evidence that weight loss may reduce the risk of recurrence, little is known about the impact of intentional weight loss on prostate cancer outcomes. The EMPOWER study investigates whether weight loss can be used as a “first line therapy” for overweight and obese men with evidence of biochemical recurrence following local treatment.
Additional locations may be listed on ClinicalTrials.gov for NCT04266431.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Determine whether a lifestyle intervention focused on weight loss, EMPOWER, reduces prostate cancer progression at 12 months.
SECONDARY OBJECTIVES:
I. Determine whether weight loss reduces prostate cancer progression at 12 months.
II. Determine whether the biomarkers of insulin resistance and sex steroid hormones are associated with prostate cancer progression among men randomized to standard of care.
III. Determine whether changes in biomarkers of insulin resistance and sex steroid hormones are associated with prostate cancer progression.
IV. Determine whether changes in diet mediate any observed association between weight loss and progression.
V. Determine whether changes in physical activity mediate any observed association between weight loss and progression.
VI. Determine weight loss is associated with changes in health-related patient reported outcomes including depression, sleep quality, and PSA anxiety.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients complete EMPOWER intervention consisting of coach phone calls over 30 minutes weekly for months 1-3 and monthly for months 4-24. Patients also record daily food and drink intake and amount of time exercised on the study website or study mobile application (app).
GROUP II: Patients receive information on recommendations for healthy prostate cancer survivorship per standard of care.
Participants are scheduled for 3 follow-up visits at 6, 12 and 24 months after the baseline visit and concurrent with follow-up appointments with their medical oncologist.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorCorinne E. Joshu