Interventional Recruiting Phase 2
NCT05832086 on ClinicalTrials.gov
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
- Sponsor: Stephen Freedland
- Collaborators: National Cancer Institute (NCI)
- Enrollment: 138 (Estimated)
- Study start: 2023-09-13 (Actual)
- Primary completion: 2028-09-30 (Estimated)
- Study completion: 2029-03-30 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: None
- PrimaryPurpose: Treatment
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.
Conditions
- Prostate Adenocarcinoma
Intervention / Treatment
- Behavioral: Fasting Mimicking Diet (FMD)
- Behavioral: Standard Anti-Cancer Diet
Primary Outcome Measures
-
Response to cancer treatment
(6 Month visit)
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.
Countries
United States
Locations and Investigators
-
Beckman Research Institute of the City of Hope, Duarte, United States (Recruiting)
- Tanya Dorff, MD
-
Cedars-Sinai Medical Center, Los Angeles, United States (Recruiting)
- Stephen Freedland, MD
- Gillian Gresham, PhD
- Edwin Posadas, MD
- Mourad Tighiouart, PhD
- Sungyong You, PhD
-
Duke University, Durham, United States (Recruiting)
- Pao-Hwa Lin, PhD
- Daniel George, MD
- Matthew Labriola, MD