This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians.
This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.
Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRI scan)
Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or darolutamide with or without current or prior chemotherapy
Reads, writes, and understands English or Spanish and has telephone access for remote contact with the study dietitian.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Allergies to any ingredients listed on the Xentigen Ingredient List
Men with diabetes who are not on stable doses of antihyperglycemic medication for at least 6 months and without physician consent that they may safely hold antihyperglycemic medication during the 5 days of FMD
Regularly practicing a fasting diet that in the opinion of the study physician would impact study participation
Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) that in the opinion of the study physician would preclude enrollment in this study.
Parallel
Fasting Mimicking Diet (FMD)
BehavioralConsume the FMD (Xentigen, L-Nutra, Los Angeles, CA) for 5 days every monthly cycle for 6 cycles total in 6 months.
Standard Anti-Cancer Diet
BehavioralWill receive standard of care diet and exercise recommendations from the study dietitian. The diet advice will be consistent with the American Cancer Society for cancer survivors and exercise recommendation of a goal of 150 minutes/week of cardiovascular exercise and weight resistance training at least twice a week.
Response to cancer treatment
Will be measured by the proportion of patients who achieved PSA nadir ≤0.2 ng/dL at any time point within the 6-month study and absolute PSA nadir.
Castration resistance 1
will be measured by Testosterone (ng/dl)
Castration resistance 2
will be measured by PSA levels (ng/mL)
Metabolic Toxicity 1
Will be measured by the changes in HbA1c
Metabolic Toxicity 2
Will be measured by the changes in waist circumference
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Stephen Freedland
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
National Cancer Institute (NCI)
Collaborator
