This randomized phase II trial studies how well carbohydrate-restricted diet works in treating patients with previously treated prostate cancer. A low-carbohydrate diet may prevent or slow disease progression in patients with prostate cancer who failed to respond to prior therapy.
Additional locations may be listed on ClinicalTrials.gov for NCT01763944.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Examine the effects of carbohydrate restriction on prostate specific antigen doubling time (PSADT) relative to a no-dietary intervention control among men with prostate specific antigen (PSA) recurrence after definitive therapy for prostate cancer.
II. Examine the effects of carbohydrate restriction on weight loss.
III. Examine the effects of carbohydrate restriction on markers of energy metabolism including resting metabolic rate.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive a carbohydrate-restricted diet (less than 20 grams carbohydrate/day) for 6 months.
ARM II: Patients receive no diet control for 6 months. After 6 months, patients are offered the same carbohydrate-restricted diet as in Arm I, if interested.
Lead OrganizationDuke University Medical Center
Principal InvestigatorPao-Hwa Lin