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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Adenocarcinoma
• Intervention / Treatment: Behavioral: Fasting Mimicking Diet (FMD); Behavioral: Standard Anti-Cancer Diet

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Trial Recruitment Navigator; Phone Number: 3104232133; Email: cancer.trial.info@cshs.org
• Study Contact Backup: Name: Stephen Freedland, MD; Phone Number: 310-423-3497; Email: Stephen.Freedland@cshs.org

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Not yet recruiting
      • Beckman Research Institute of the City of Hope
      • Contact: Tanya Dorff, MD; Phone Number: 626-256-4673; Email: tdorff@coh.or
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Sub-Investigator: Edwin Posadas, MD
      • Sub-Investigator: Mourad Tighiouart, PhD
      • Sub-Investigator: Sungyong You, PhD
      • Contact: Stephen Freedland, MD; Phone Number: 310-423-3497; Email: Stephen.Freedland@cshs.org
      • Sub-Investigator: Gillian Gresham, PhD
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Not yet recruiting
      • Duke University
      • Contact: Pao-Hwa Lin, PhD; Phone Number: 919-660-6685; Email: lin00004@mc.duke.edu
      • Sub-Investigator: Daniel George, MD
      • Sub-Investigator: Matthew Labriola, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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
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
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
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

Collaborators and Investigators

• Sponsor: Stephen Freedland
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Fasting
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: IIT2023-02-FREEDLAND-FAST-PRO; 1R01CA280081-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No