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

NCT05832086 | Recruiting Phase 2 DMC

• 2 other identifiers: IIT2023-02-FREEDLAND-FAST-PRO1R01CA280081-01
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 3

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

Keywords

Fasting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Castration resistance 1

  6 Month visit

• Castration resistance 2

  6 Month visit

• Metabolic Toxicity 1

  Change from Baseline to 6 Month visit

• Metabolic Toxicity 2

  Change from Baseline to 6 Month visit

• Metabolic Toxicity 3

  Change from Baseline to 6 Month visit

Study Arms (2)

Fasting Mimicking Diet

EXPERIMENTAL

Intermittent fasting using a fasting mimicking diet

Behavioral: Fasting Mimicking Diet (FMD)

Standard Anti-Cancer Diet

PLACEBO COMPARATOR

Standard Anti-Cancer Diet

Behavioral: Standard Anti-Cancer Diet

Interventions

Fasting Mimicking Diet (FMD) BEHAVIORAL

Consume the FMD (Xentigen, L-Nutra, Los Angeles, CA) for 5 days every monthly cycle for 6 cycles total in 6 months.

Fasting Mimicking Diet

Standard Anti-Cancer Diet BEHAVIORAL

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.

Standard Anti-Cancer Diet

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephen Freedland: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Beckman Research Institute of the City of Hope

Duarte, California, 91010, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Clinical Trial Recruitment Navigator

CONTACT

3104232133; GroupCancerTrialInformation@cshs.org

Stephen Freedland, MD

CONTACT

310-423-3497; Stephen.Freedland@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Center for Integrated Research in Cancer and Lifestyle; Co-Director, Cancer Genetics and Prevention Program; Professor, Surger

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 27, 2023
• Study Start: September 13, 2023
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)