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Water-Only Fasting or Ketone Supplementation for Prostate Cancer

This study is looking at whether 7 days of water-only fasting or taking a ketone supplement is safe and possible for men with prostate cancer. Researchers want to see if these approaches can help the immune system fight cancer cells, as animal studies suggest fasting might do this by changing the body's metabolism (how it uses energy). The study will enroll 40 men aged 18 or older who have prostate cancer, either localized or metastatic (spread to other parts of the body). Success for this study means seeing how many people complete the 7-day fasting or ketone supplementation and tracking any side effects over one year. The current status of this study is unclear.

Study design
This interventional study plans to enroll 40 participants. It will look at two groups: those with local prostate cancer and those with metastatic prostate cancer.
What's involved
You would be instructed to perform a 7-day water-only fast or drink a ketone supplement for 7 days, followed by a 3-day refeeding protocol. You may also need to agree to biopsies.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year to track adverse events and completion rates.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06826924

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

Recruiting
NAAges 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~40 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:FastingKetone Supplementation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of adverse events and serious adverse events (SAEs)
Measured over 1 year
+1 more outcome measured

Conditions

Prostate Cancer
Prostate Cancer Metastatic

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Laura Sena, MD, PhD · PRINCIPAL_INVESTIGATOR · SKCCC Johns Hopkins Medical Institution

Who to contact

Laura Sena, MD, PhD
[email protected]
410-502-3825
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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:
Acceptable electrolyte and acid/base status:
Ability to understand and willingness to sign a written informed consent document

Exclusion

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

What this trial measures

  • Number of adverse events and serious adverse events (SAEs)1 year

    Number of adverse events and serious adverse events (SAEs) assessed according to CTCAE v5.0

  • Number patients who complete 7 days of fasting or the ketogenic very low-calorie diet of ketone supplementation of all enrolled patients.1 year

    Number patients who complete 7 days of fasting or the ketogenic very low-calorie diet of ketone supplementation of all enrolled patients.