NCT06826924

7-Days Water-Only Fasting Trial in Prostate Cancer

A Study of 7-days Water-only Fasting in Patients With Metastatic Prostate Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Activating the immune system to kill cancer cells is a promising therapeutic strategy for some patients with cancer. Unfortunately, current immune-targeting treatments do not work for patients with prostate cancer. In animal models of cancer, fasting can reprogram the body's metabolism and immune cell function to help immune cells kill cancer cells. The purpose of this study is to determine whether 7 days of water-only fasting or a very low-calorie diet is safe and feasible for patients with metastatic prostate cancer. This will help the investigators develop future studies to test whether incorporating periods of fasting or very low calorie diets into treatment plans for prostate cancer can improve outcomes from this disease.

Detailed description

Seven days of water-only fasting is safe and feasible in healthy adults. Fasting enhances anti-tumor immunity in animal models of cancer. The primary objective of this study is to determine if 7 days of water-only fasting or a ketogenic very low-calorie diet is safe and feasible in patients with metastatic prostate cancer. Patients with metastatic prostate cancer will be instructed to perform a 7-day water-only fast followed by a 3-day refeeding protocol to evaluate safety and feasibility. Eligible patients are those with metastatic prostate adenocarcinoma. Patients will perform a 7-day water-only fast followed by a 3-day refeeding protocol. Patients will be monitored by regular labs and a clinic visit on Day 3. Patients may deviate to a ketogenic very low-calorie diet at any time between Day 1 and Day 7.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Fasting	7 days of water-only fasting

Timeline

• Start date: 2025-06-03
• Primary completion: 2026-06-03
• Completion: 2026-06-03
• First posted: 2025-02-14
• Last updated: 2025-07-08

Locations

1 site across 1 country: United States