This clinical trial examines weight loss interventions in reducing cancer progression in prostate cancer patients under active surveillance. Intensive lifestyle interventions that recommend modest reductions in daily caloric intake (i.e. continuous calorie energy reduction [CER]) are the gold-standard for weight loss, and have been tested in cancer survivors, including prostate cancer patients. However, few interventions have been developed for low-risk prostate cancer patients on active surveillance. Intermittent fasting (IF) may be superior to CER in the context of prostate cancer progression given its dual role in weight loss and metabolic switching from the use of glucose as a fuel source to the use of fatty acids and ketone bodies. This study may help researcher determine which weight loss strategies work better among males that may help reduce their risk of prostate cancer recurrence, and other negative health effects of being overweight.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05764330.
PRIMARY OBJECTIVES:
I. Develop two evidence-based behavioral weight loss intervention programs (IF and CER) with a goal to cause weight loss in prostate cancer (PCa) patients on active surveillance (AS).
II. Determine initial comparative effectiveness of two intervention programs (IF and CER) on weight loss and PCa progression outcomes.
SECONDARY OBJECTIVE:
I. Compare the effects of the interventions on biomarkers underlying obesity and PCa to provide mechanistic insights and potential surrogate biomarkers for PCa prognosis.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo CER intervention consisting of remote lesson containing information and behavioral strategies about weight loss, session with study interventionist to review lessons, and self-monitoring of body weight. Patients also undergo collection of blood samples throughout the trial.
ARM II: Patients undergo IF intervention consisting of remote lesson containing information and behavioral strategies about fasting, session with study interventionist to review lessons, and self-monitoring of body weight. Patients also undergo fasting 2 days per week and eat according to the National Cancer Institute (NCI) guidelines the remaining 5 days. Patients also undergo collection of blood samples throughout the trial.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorKaren Yeary
