Using a fasting-mimicking diet to improve prostate cancer control and metabolic health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 clinical trial involves 138 patients with metastatic castrate sensitive prostate adenocarcinoma who will be randomly assigned to either a fasting mimicking diet or a usual diet while receiving standard cancer treatment. The fasting mimicking diet consists of consuming specific L-Nutra products for 5 days each month over a period of 6 months. The study aims to evaluate the impact of this dietary approach on the effectiveness of cancer treatment and metabolic outcomes. Participants will be monitored by trained dietitians to ensure adherence to the diet.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Clinical Trial Recruitment Navigator
• Email: GroupCancerTrialInformation@cshs.org
• Phone: 310-423-5842

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.