Actively Recruiting
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
Led by Stephen Freedland · Updated on 2026-05-06
138
Participants Needed
3
Research Sites
289 weeks
Total Duration
On this page
Sponsors
S
Stephen Freedland
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic castrate sensitive prostate adenocarcinoma confirmed by biopsy and metastatic disease confirmed by biopsy or MRI scan
- Men receiving or planning to start first-line intensified androgen deprivation therapy with abiraterone, apalutamide, enzalutamide, or darolutamide within 30 days of registration, with or without current or prior chemotherapy
- Able to read, write, and understand English or Spanish and have telephone access for remote contact with the study dietitian
- Provided written informed consent and able to comply with study requirements
You will not qualify if you...
- Allergies to any ingredients listed on the Xentigen Ingredient List
- Men with diabetes not on stable antihyperglycemic medication doses for at least 6 months or without physician's consent to safely hold medication during fasting mimicking diet
- Regularly practicing a fasting diet that may impact study participation as judged by the study physician
- Significant co-morbidities such as cardiac, pulmonary, or liver disease, or ongoing alcohol/drug abuse that preclude enrollment
- Body Mass Index (BMI) less than 20 kg/m2
- Men actively trying to lose weight, on weight loss medications, or planning weight loss surgery in the next six months
- Self-reported weight loss of 10% or more in the last 6 months
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Beckman Research Institute of the City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
C
Clinical Trial Recruitment Navigator
CONTACT
S
Stephen Freedland, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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