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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 7 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether 7 days of drinking only water, a very low-calorie ketogenic diet, or ketone supplements are safe and doable for adults with prostate cancer. Ketones are substances the body makes when it uses fat for fuel. The results will help researchers plan future studies of these approaches in prostate cancer treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with prostate adenocarcinoma, a type of prostate cancer.
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Agree to tissue samples if cancer has spread to soft tissue that can be sampled. For cancer only in the prostate, agree to a prostate tissue sample or prostate removal on day 8, 9, or 10.
  • Have PSA levels that are not falling on the two latest tests, taken at least 1 week apart in the past 2 months. PSA is a blood marker used to track prostate cancer.
  • Have a body mass index (BMI), a measure of weight compared with height, between 20 and 35.
  • No past prostate cancer treatment is required. If you had cancer treatment or took steroids, the last dose must have been more than 2 weeks ago, and you must be able to stop steroids.
  • Meet the study's blood test limits for liver and kidney health, blood cell counts, body salts, and acid balance.
  • Be able to understand the study and willing to sign a consent form.

Who can't join

  • Be unable to do work activities because of your health, or have lost 5% or more of your weight without trying in the past 3 months.
  • Have diabetes, defined by an HbA1c blood sugar test of 6.5% or higher or use of diabetes medicines.
  • Have an active infection that is not controlled. People with HIV may qualify if they meet the study's immune cell and virus limits, have taken HIV treatment for at least 4 weeks, and have had no infection linked to weak immunity in the past year. People with hepatitis C may qualify after treatment to cure it if virus levels are below the test's measuring limit.
  • Take medicines that weaken the immune system, including steroids.
  • Take water pills (diuretics) or beta blockers.
  • Have a history of an abnormal heart rhythm, heart attack, heart valve disease, or high blood pressure in the lungs, or have an abnormal heart tracing test (EKG).
  • Drink alcohol every day.
  • Have a condition or problems with thinking that the study doctor believes could affect your safety, ability to consent, or ability to follow study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MD