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

NCT ID: NCT05832086

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-13
• Study Completion Date: 2029-03-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fasting Mimicking Diet

Intermittent fasting using a fasting mimicking diet

Group Type: EXPERIMENTAL

Fasting Mimicking Diet (FMD)

Intervention Type: BEHAVIORAL

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

Standard Anti-Cancer Diet

Standard Anti-Cancer Diet

Group Type: PLACEBO_COMPARATOR

Standard Anti-Cancer Diet

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Stephen Freedland

OTHER

Sponsor Role: lead

Responsible Party

Stephen Freedland

Director, Center for Integrated Research in Cancer and Lifestyle; Co-Director, Cancer Genetics and Prevention Program; Professor, Surger

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beckman Research Institute of the City of Hope

Duarte, California, United States

Site Status: RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trial Recruitment Navigator

Role: CONTACT

cancer.trial.info@cshs.org

3104232133

Stephen Freedland, MD

Role: CONTACT

Stephen.Freedland@cshs.org

310-423-3497

Facility Contacts

Tanya Dorff, MD

Role: primary

tdorff@coh.or

(626) 256-4673

Stephen Freedland, MD

Role: primary

Stephen.Freedland@cshs.org

310-423-3497

Pao-Hwa Lin, PhD

Role: primary

lin00004@mc.duke.edu

(919) 660-6685

Other Identifiers

1R01CA280081-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IIT2023-02-FREEDLAND-FAST-PRO

Identifier Type: -

Identifier Source: org_study_id