7-day water-only fasting for metastatic prostate cancer
A Study of 7-days Water-only Fasting in Patients With Metastatic Prostate Cancer
This study will test whether a 7-day water-only fast (with a ketogenic very low-calorie option) is safe and doable for people with metastatic prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06826924 on ClinicalTrials.gov |
What this trial studies
Participants with metastatic prostate adenocarcinoma will attempt a 7-day water-only fast followed by a 3-day supervised refeeding period, with the option to switch to a ketogenic very low-calorie diet during the fasting window. The protocol includes regular laboratory monitoring and a clinic visit on Day 3, and requires a soft-tissue metastasis that can be biopsied for correlative studies. The main goals are to determine safety and feasibility of the fasting intervention in this patient population and to collect biological samples to study immune and metabolic changes. Prior cancer treatments are allowed if sufficiently remote, and steroid use must be stopped before enrollment.
Who should consider this trial
Good fit: Adults (≥18) with metastatic prostate adenocarcinoma, ECOG 0–1, BMI 20–35 kg/m2, a soft-tissue metastasis amenable to biopsy, and PSA that is not currently declining are ideal candidates.
Not a fit: Patients with poor performance status, BMI outside 20–35, uncontrolled comorbidities, ongoing required steroid therapy, or no biopsy-accessible metastasis are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could enhance anti-tumor immune activity and help make existing prostate cancer treatments more effective for some patients.
How similar studies have performed: Short-term fasting has shown immune and anti-tumor effects in animal models and is safe in healthy adults, but controlled data in metastatic prostate cancer patients are limited and largely untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Laura Sena, MD, PhD — SKCCC Johns Hopkins Medical Institution
- Study coordinator: Laura Sena, MD, PhD
- Email: laura.sena@jhmi.edu
- Phone: 410-502-3825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.