Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 2. Age ≥18 years 3. Diagnosis of metastatic adenocarcinoma of the prostate 4. Must have a soft tissue metastasis amenable to biopsy 5. Prostate-specific antigen (PSA) is not currently declining, as determined by most recent 2 measurements taken at least 1 week apart in previous 2 months. 6. BMI between 20 and 35 kg/m2 7. Prior treatment with any prostate cancer therapy is permitted if \>2 weeks from last dose. Patients are not required to have received prior treatment for prostate cancer. 8. Prior treatment with steroids is permitted if \>2 weeks from last dose. Patients who cannot be weaned off steroids are not eligible. 9. Acceptable liver function: 1. Bilirubin \< 2.5 times institutional upper limit of normal (ULN) 2. Aspartate transaminase (AST) (SGOT) and Alanine transaminase (ALT) (SGPT) \< 2.5 times ULN 10. Acceptable renal function: glomerular filtration rate (GFR) of 50 mL/min/1.73 m2 or