Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes

Conditions
-----------------
Prostate Adenocarcinoma

Intervention / Treatment
-----------------
* Behavioral: Fasting Mimicking Diet (FMD)
* Behavioral: Standard Anti-Cancer Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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. Body Mass Index (BMI) <20kg/m2 Men actively trying to lose weight OR on weight loss medications (including but not limited to Contrave, Saxenda, Xenical) or planning to receive weight loss surgery in the next six months Self-reported weight loss ≥ 10% in the last 6 months
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting Mimicking Diet<br>Intermittent fasting using a fasting mimicking diet | Behavioral: Fasting Mimicking Diet (FMD)<br>* Consume the FMD (Xentigen, L-Nutra, Los Angeles, CA) for 5 days every monthly cycle for 6 cycles total in 6 months.<br>|
| Placebo Comparator: Standard Anti-Cancer Diet<br>Standard Anti-Cancer Diet | Behavioral: Standard Anti-Cancer Diet<br>* Will 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 Month visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Castration resistance 1 | will be measured by Testosterone (ng/dl) | 6 Month visit | 
| Castration resistance 2 | will be measured by PSA levels (ng/mL) | 6 Month visit | 
| Metabolic Toxicity 1 | Will be measured by the changes in HbA1c | Change from Baseline to 6 Month visit | 
| Metabolic Toxicity 2 | Will be measured by the changes in waist circumference | Change from Baseline to 6 Month visit | 
| Metabolic Toxicity 3 | Will be measured by the changes in fat mass (assessed via bioelectrical expedience) | Change from Baseline to 6 Month visit | 
| Metabolic Toxicity 4 | Will be measured by the changes in body weight | Change from Baseline to 6 Month visit | 
| Self-reported overall well-being | will be measured in changes in the scores calculated from the Medical Outcomes Study Short Form Health Survey (SF-12) questionnaire. Scores can range from 12-56 with a higher score indicating a better outcome. | Change from Baseline to 6 Month visit | 
| Self-reported energy levels | will be measured in changes in the scores calculated from the Godin leisure-time physical activity questionnaire. Scores can range from 0 and above, with a higher score indicating a better physical activity outcome. | Change from Baseline to 6 Month visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fasting