Recruiting

Fasting in Cancer7-Days Water-Only Fasting or Ketone Supplementation Trial in Prostate Cancer

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06826924

Conditions

Prostate Cancer

Prostate Cancer Metastatic

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fasting

Ketone Supplementation

Study Details

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 likely by increasing ketosis. The purpose of this study is to determine whether 7 days of water-only fasting or a ketogenic very low-calorie diet or ketone supplementation is safe and feasible for patients with prostate cancer. This will help the investigators develop future studies to test whether incorporating periods of fasting or very low calorie diets or a ketone supplement into treatment plans for prostate cancer can improve outcomes from this disease.

Conditions

Prostate Cancer

Prostate Cancer Metastatic

Study ID

NCT06826924

Start date

Jun 3, 2025

Status verified date

Jun, 2026

Completion date

Jun 3, 2027

Anticipated

Primary completion date

Jun 3, 2027

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Age ≥18 years
Diagnosis of adenocarcinoma of the prostate
If a soft tissue metastasis amenable to biopsy is present, then the participant must agree to biopsies.
If the participant has local prostate cancer, then the participant must agree to prostate biopsy or radical prostatectomy on days 8, 9, or 10. -. 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.
BMI between 20 and 35 kg/m2
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.
Prior treatment with steroids is permitted if >2 weeks from last dose. Patients who cannot be weaned off steroids are not eligible.
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

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.
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.

Acceptable electrolyte and acid/base status:

1. Sodium 135-148 millimoles (mM)
2. Potassium 3.5-5.1mM
3. Carbon Dioxide 21-31mM
4. Phosphorus 2.7-4.5mM
5. Magnesium ≥1.6mM
6. Lactate ≤2mM

Ability to understand and willingness to sign a written informed consent document

Exclusion criteria:

ECOG Performance status ≥2
Unintentional weight loss greater than or equal to 5% in previous 3 months
Diabetes mellitus, defined as HbA1c ≥6.5% or use of medications for diabetes
Active uncontrolled infection. Patients with a history of HIV/AIDS may be eligible if CD4+ T cell counts are ≥ 350 cell/ul, the patients have had no opportunistic infection within the past 12 months, they 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 patients have completed curative antiviral treatment and the HCV viral load is below the limit of quantification.
Use of immunosuppressive medications including steroids
Use of diuretics or beta blockers
History of cardiac arrythmia, myocardial infarction, valvular heart disease, or pulmonary hypertension
Abnormal screening EKG
Daily alcohol consumption
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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fasting with Local Prostate Cancer

7-day water-only fast followed by a 3-day refeeding

experimental: Ketone Supplementation with Local Prostate Cancer

7-day ketone supplementation

experimental: Fasting with Metastatic Prostate Cancer

7-day water-only fast followed by a 3-day refeeding

experimental: Ketone Supplementation with Metastatic Prostate Cancer

7-day ketone supplementation

Interventions

Fasting

7 days of water-only fasting

Ketone Supplementation

7 days of ketone supplementation

Primary outcome measure

Number of adverse events and serious adverse events (SAEs) [ Time Frame: 1 year ]
Number patients who complete 7 days of fasting or the ketogenic very low-calorie diet of ketone supplementation of all enrolled patients. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Laura Sena, MD, PhD

410-502-3825 laura.sena@jhmi.edu

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Laura Sena

Laura.Sena@jhmi.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

fasting
ketone supplementation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-06-30.