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

June 25, 2026 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

A Study of 7-days Water-only Fasting or Ketone Supplementation in Patients With Prostate Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 likely through ketosis. The primary objective of this study is to determine if 7 days of water-only fasting or a ketogenic very low-calorie diet or ketone supplementation is safe and feasible in patients with prostate cancer.

Patients with 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. Two cohorts will be evaluated including (1) patients with local prostate cancer and (2) patients with metastatic prostate cancer. Two additional cohorts, including patients with (3) local and (4) metastatic prostate cancer, will be instructed to drink a ketone supplement for 7 days to evaluate safety and feasibility.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fasting with Local Prostate Cancer
7-day water-only fast followed by a 3-day refeeding
Behavioral: Fasting
7 days of water-only fasting
Experimental: Ketone Supplementation with Local Prostate Cancer
7-day ketone supplementation
Dietary supplement: Ketone Supplementation
7 days of ketone supplementation
Experimental: Fasting with Metastatic Prostate Cancer
7-day water-only fast followed by a 3-day refeeding
Behavioral: Fasting
7 days of water-only fasting
Experimental: Ketone Supplementation with Metastatic Prostate Cancer
7-day ketone supplementation
Dietary supplement: Ketone Supplementation
7 days of ketone supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events and serious adverse events (SAEs)
Time Frame: 1 year
Number of adverse events and serious adverse events (SAEs) assessed according to CTCAE v5.0
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
Number patients who complete 7 days of fasting or the ketogenic very low-calorie diet of ketone supplementation of all enrolled patients.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in quality of life and function based on number of steps
Time Frame: Daily from Day 1 to Day 10
Changes in quality of life and function during the study based on the number of steps per day by an activity tracker.
Daily from Day 1 to Day 10
Changes in quality of life and function using Functional Assessment of Cancer Therapy - General (FACT-G) survey
Time Frame: Screening and daily from Day 1 to Day 10
Changes in quality of life and function during the study by: Score of a daily modified FACT-G survey. Score range 0-108, higher score better quality of life.
Screening and daily from Day 1 to Day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

United States Department of Defense
Prostate Cancer Foundation
Abott Lingo Wearables

Investigators

  • Principal Investigator: Laura Sena, MD, PhD, SKCCC Johns Hopkins Medical Institution

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2025

Primary Completion (Estimated)

June 3, 2027

Study Completion (Estimated)

June 3, 2027

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J2487
  • IRB00456089 (Other Identifier: JHM IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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