Could fasting help the immune system fight prostate cancer?
NCT ID NCT06826924
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This study explores whether a 7-day water-only fast or ketone supplements are safe and doable for men with prostate cancer. The idea is that fasting may change the body's metabolism and boost immune cells to better attack cancer. Researchers will track side effects and how many participants complete the full 7 days, with the goal of designing future trials that combine fasting with cancer treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- water-only fasting or ketone supplementation
- What this could lead to
- If safe and feasible, this approach could pave the way for larger studies testing whether fasting or ketones help the immune system fight prostate cancer.
- What could go wrong
- This is a small, early feasibility study with only 40 participants, so results may not apply broadly. Fasting for 7 days carries risks like dehydration or nutrient deficiency.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2025
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Prostate cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
RECRUITINGBaltimore, Maryland, 21231, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?