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Fasting-Mimicking Diet for Metastatic Prostate Cancer

This study is looking at whether a special diet, called a Fasting Mimicking Diet (FMD), can help improve how well prostate cancer treatment works. It's for men with metastatic castrate sensitive prostate adenocarcinoma (prostate cancer that has spread and responds to hormone therapy) who are starting certain anti-cancer medications like abiraterone, apalutamide, enzalutamide, or darolutamide. You would either follow the FMD for 5 days each month for six months, or receive standard diet advice. The main goal is to see how your cancer responds to treatment after six months. This study plans to include 138 participants, but its current recruitment status is unclear.

Study design
This is a Phase 2, randomized study involving 138 men across multiple locations. Participants will be randomly assigned to either the Fasting Mimicking Diet group or the standard anti-cancer diet group.
What's involved
If you join, you would follow a specific Fasting Mimicking Diet for 5 days each month for a total of 6 months, or receive standard diet and exercise recommendations. Your diet will be monitored by research dietitians.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, response to cancer treatment, is measured at the 6-month visit.

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NCT05832086

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

Recruiting
PHASE2All AgesInterventionalTreatment
Stephen Freedland
~138 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Fasting Mimicking Diet (FMD)Standard Anti-Cancer Diet

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response to cancer treatment
Measured over 6 Month visit

Conditions

Prostate Adenocarcinoma

Explore related trials

Prostate Carcinoma

Where it's being run

3 sites across 2 states
California2
North Carolina1

Who to contact

Clinical Trial Recruitment Navigator
[email protected]
310-423-5842
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Response to cancer treatment6 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.