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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment138 people
  • Recruiting US sites3
  • SponsorStephen Freedland
  • RegistryNCT05832086

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes: a one-minute explainerNCT058320861 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • AgeNo minimum to no maximum
  • SexMale
  • Healthy volunteersNo

You may be able to join 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 cannot join 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • 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.

The study

Treatment groups

Randomized · Parallel · masking: None

Fasting Mimicking Diet (Experimental)

Intermittent fasting using a fasting mimicking diet

Standard Anti-Cancer Diet (Placebo Comparator)

Standard Anti-Cancer Diet

Goals

What the study measures

Main goals

  • Response to cancer treatment (6 Month visit)

Other goals

  • Castration resistance 1
  • Castration resistance 2
  • Metabolic Toxicity 1
  • Metabolic Toxicity 2
  • Metabolic Toxicity 3
  • Metabolic Toxicity 4
  • Self-reported overall well-being
  • Self-reported energy levels

Planned enrollment: 138 (estimated).

Where

Recruiting US sites

  • Beckman Research Institute of the City of Hope, Duarte, California
  • Cedars-Sinai Medical Center, Los Angeles, California
  • Duke University, Durham, North Carolina

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 9, 2026. Public record; not medical advice.

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