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NCT Number: NCT05832086

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.

Recruiting

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Beckman Research Institute of the City of Hope, Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Response to cancer treatment

    Time frame: 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.

Secondary outcomes

  1. Castration resistance 1

    Time frame: 6 Month visit

    will be measured by Testosterone (ng/dl)

  2. Castration resistance 2

    Time frame: 6 Month visit

    will be measured by PSA levels (ng/mL)

  3. Metabolic Toxicity 1

    Time frame: Change from Baseline to 6 Month visit

    Will be measured by the changes in HbA1c

  4. Metabolic Toxicity 2

    Time frame: Change from Baseline to 6 Month visit

    Will be measured by the changes in waist circumference

  5. Metabolic Toxicity 3

    Time frame: Change from Baseline to 6 Month visit

    Will be measured by the changes in fat mass (assessed via bioelectrical expedience)

  6. Metabolic Toxicity 4

    Time frame: Change from Baseline to 6 Month visit

    Will be measured by the changes in body weight

  7. Self-reported overall well-being

    Time frame: Change from Baseline to 6 Month visit

    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.

  8. Self-reported energy levels

    Time frame: Change from Baseline to 6 Month visit

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Recruitment Navigator

CONTACT

[email protected]

3104232133

Stephen Freedland, MD

CONTACT

[email protected]

310-423-3497

Sponsors and collaborators

Lead sponsor

Stephen Freedland

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Apr 27, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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