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

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

This study is testing if a special fasting-mimicking diet can help men with advanced prostate cancer feel better and improve their overall health while they receive standard treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sex: Male
• Sponsor: Cedars-Sinai Medical Center (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Duarte, California and 2 other locations)
• Trial ID: NCT05832086 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men with metastatic castrate sensitive prostate adenocarcinoma who are starting first-line intensified androgen deprivation therapy.

Not a fit: Patients with diabetes not on stable medication or those regularly practicing a fasting diet may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance cancer treatment effectiveness and improve metabolic health in patients with prostate cancer.

How similar studies have performed: Other studies have shown promising results with dietary interventions in cancer treatment, suggesting potential for success in this approach.

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

Where this trial is running

Duarte, California and 2 other locations

• 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

Conditions Prostate Adenocarcinoma; Fasting