NCT06826924 7-Days Water-Only Fasting or Ketone Supplementation Trial in Prostate Cancer
| NCT ID | NCT06826924 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-06-03 |
| Primary Completion | 2027-06-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-06-03 with a primary completion date of 2027-06-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Laura Sena, MD, PhD
PRINCIPAL INVESTIGATOR
SKCCC Johns Hopkins Medical Institution
Frequently Asked Questions
Who can join the NCT06826924 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06826924 currently recruiting?
Yes, NCT06826924 is actively recruiting participants. Contact the research team at laura.sena@jhmi.edu for enrollment information.
Where is the NCT06826924 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06826924 clinical trial?
NCT06826924 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Laura Sena, MD, PhD at SKCCC Johns Hopkins Medical Institution. The trial plans to enroll 40 participants.
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