Prostate Cancer Clinical Trial
Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer
The study is comparing the effect on weight of providing home-delivered whole-food, plant-based meals versus standard, general nutritional counseling to men with prostate cancer on androgen-deprivation therapy (ADT).
Prostate cancer is the most common cancer diagnosis for men in the United States. For patients with advanced or recurrent disease, ADT has is the cornerstone of systemic treatment. Overall, almost half of prostate cancer patients will undergo ADT at some point during their treatment. Unfortunately, ADT has metabolic side effects, including weight gain, central adiposity, and insulin resistance. This study is a multi-site randomized phase II trial comparing a home-delivered whole food, plant-based diet (WFPBD) with specialized behavioral coaching to standard dietary intervention with general nutritional counseling to assess the efficacy of a WFPBD in promoting weight loss in overweight/obese men receiving ADT. The home-delivered WFPBD will be for 28 days with 12 meals a week followed by 28 days with 6 meals a week; followed by self-prepared WFPBD for 18 weeks (for a total of 26 weeks).
The study hypothesis is that a WFPBD will decrease body weight and decrease systemic metabo-inflammation in overweight/obese men (BMI > 27) with prostate cancer receiving ADT. Secondary objectives will be to assess the effects of a WFPBD on adiposity, markers of inflammation (hsCRP, IL-6), metabolism (insulin, glucose, leptin, adiponectin), and fecal microbiota that may contribute to prostate cancer progression; to assess the effects of a WFPBD on quality of life; and to assess the durability of any observed effect (weight, adiposity, markers of inflammation and metabolism, fecal microbiota) of the intervention after cessation of the meal-delivery service.
Histologically or cytologically confirmed adenocarcinoma of the prostate
Receiving androgen deprivation therapy (ADT) with an LHRH/GnRH analogue (agonist/antagonist); or have undergone bilateral orchiectomy. Patients with localized prostate cancer, non-metastatic castrate resistant prostate cancer (CRPC), metastatic hormone sensitive prostate cancer and metastatic CRPC are all eligible.
On ADT for at least 24 weeks pre-study with anticipation of at least 26 more weeks of therapy from the date of initiation of the dietary intervention
Patients receiving an anti-androgen (including, but not limited to drugs such as bicalutamide, abiraterone, enzalutamide or apalutamide) are eligible if they have been on therapy for at least 3 months and plan to continue for the duration of the study
At least 3 months post completion of chemotherapy and/or radiation
Bone resorptive agents such as bisphosphanates and denosumab are allowed.
Testosterone level <50 ng/dL
Age â‰¥ 45 years
BMI â‰¥ 27
ECOG performance status of 0 to 1
Adequate organ and marrow function, based upon meeting all of the following laboratory criteria:
White blood cell count â‰¥ 2500/mm3 (â‰¥ 2.5 GI/L)
Platelets â‰¥ 100,000/mm3 (â‰¥ 100 GI/L) without transfusion
Hemoglobin â‰¥ 9 g/dL (â‰¥ 90 g/L)
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin â‰¤ 2x ULN (or for subjects with Gilbert's disease direct bilirubin WNL)
Serum albumin â‰¥ 2.8 g/dl
Willingness and ability to comply with all study-related procedures
Capable of understanding and complying with the protocol requirements and must have signed the informed consent document
Insulin-dependent diabetes mellitus
Nut or legume allergy, gluten intolerance or celiac disease
Currently consuming a vegetarian or vegan diet
Concurrent participation in other nutrition or weight loss programs
Expected changes in chronic medications, including statins or oral diabetes medication during the study period (including a change in medication dosage)
Expected radiation, chemotherapy, bone resorptive agents or anti-androgen within 2 months of beginning the diet intervention
Expected changes in exercise patterns during the study period
Psychiatric illnesses or social situations that would limit compliance with study requirements, including a living situation that does not allow for the delivery of Plantable prepared meals, or the inability or lack of equipment to perform basic cooking tasks
Known history of electrolyte imbalance or micronutrient deficiency, e.g., magnesium, cobalamin
Ongoing use of warfarin anticoagulants
Diagnosed, active inflammatory bowel disease
Inability to receive Emails or have a smart phone
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