7-Days Water-Only Fasting Trial in Prostate Cancer

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether a 7-day water-only fasting period or a very low-calorie diet is safe and practical for men with advanced prostate cancer. The goal is to see if fasting can help the body’s immune system better target and destroy cancer cells. While fasting has shown promise in animal studies, this trial aims to gather information that could lead to new treatment options for prostate cancer patients in the future.

To be eligible for this study, participants need to be adult men aged 18 and older who have been diagnosed with metastatic prostate cancer (meaning the cancer has spread beyond the prostate). They should have a specific performance status indicating they can carry out daily activities, and their prostate cancer should not be improving based on recent blood tests. Participants will also need to meet certain health criteria, such as having acceptable liver and kidney function. If enrolled, participants can expect to follow a fasting plan under careful monitoring to ensure their safety throughout the study.

Gender

MALE

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 higher. GFR will be estimated by the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation1 using the online calculator found on UpToDate.com
• 11. Acceptable hematologic status:
• • 1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L)
• • 2. Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)
• • 3. Hemoglobin ≥ 8 g/dL.
• 12. Acceptable electrolyte and acid/base status:
• • 1. Sodium 135-148 millimoles (mM) per litre
• • 2. Potassium 3.5-5.1mM
• • 3. Carbon Dioxide 21-31mM
• • 4. Phosphorus 2.7-4.5mM
• • 5. Magnesium ≥1.6mM
• • 6. Lactate ≤2mM
• • 13. Ability to understand and willingness to sign a written informed consent document
• Exclusion Criteria:
• • 1. ECOG Performance status ≥2
• • 2. Unintentional weight loss greater than or equal to 5% in previous 3 months
• • 3. Diabetes mellitus, defined as HbA1c ≥6.5% or use of medications for diabetes
• • 4. Active uncontrolled infection. Patients with a history of HIV/AIDS may be eligible if cluster of differentiation 4 (CD4)+ T cell counts are ≥ 350 cell/ul, the patient have had no opportunistic infection within the past 12 months, the patient have been on established antiretroviral therapy (ART) for at least four weeks, and the HIV viral load is less than 400 copies/ml prior to enrollment. Patients with a history of hepatitis C virus (HCV) infection are eligible if the patient have completed curative antiviral treatment and the HCV viral load is below the limit of quantification.
• • 5. Use of immunosuppressive medications including steroids
• • 6. Use of diuretics or beta blockers
• • 7. History of cardiac arrythmia, myocardial infarction, valvular heart disease, or pulmonary hypertension
• • 8. Abnormal screening EKG
• • 9. Daily alcohol consumption
• • 10. Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements as determined by the investigator