Prostate CancerNCT06826924
7-Days Water-Only Fasting or Ketone Supplementation Trial in Prostate Cancer
A study testing Fasting and Ketone Supplementation in people with Prostate Cancer and Prostate Cancer Metastatic, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Metastatic
- What is being tested?
- Fasting and Ketone Supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to 3 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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:
- Bilirubin < 2.5 times institutional upper limit of normal (ULN)
- 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:
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L)
- Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)
- Hemoglobin ≥ 8 g/dL.
- Acceptable electrolyte and acid/base status:
- Sodium 135-148 millimoles (mM)
- Potassium 3.5-5.1mM
- Carbon Dioxide 21-31mM
- Phosphorus 2.7-4.5mM
- Magnesium ≥1.6mM
- Lactate ≤2mM
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Laura Sena, Laura.Sena@jhmi.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Being tested
- Fasting, Ketone Supplementation
- Keywords
- fasting, ketone supplementation
- Medical subject headings
- Prostatic Neoplasms, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingBehavioural
7 days of water-only fasting
Ketone SupplementationDietary supplement
7 days of ketone supplementation
| Study group | Role | What they receive |
|---|---|---|
| Fasting with Local Prostate Cancer | Experimental | 7-day water-only fast followed by a 3-day refeeding Receives: Behavioral: Fasting |
| Ketone Supplementation with Local Prostate Cancer | Experimental | 7-day ketone supplementation Receives: Dietary Supplement: Ketone Supplementation |
| Fasting with Metastatic Prostate Cancer | Experimental | 7-day water-only fast followed by a 3-day refeeding Receives: Behavioral: Fasting |
| Ketone Supplementation with Metastatic Prostate Cancer | Experimental | 7-day ketone supplementation Receives: Dietary Supplement: Ketone Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events and serious adverse events (SAEs)
Number of adverse events and serious adverse events (SAEs) assessed according to CTCAE v5.0
Measured: 1 year
Number patients who complete 7 days of fasting or the ketogenic very low-calorie diet of ketone supplementation of all enrolled patients.
Number patients who complete 7 days of fasting or the ketogenic very low-calorie diet of ketone supplementation of all enrolled patients.
Measured: 1 year
Secondary outcomes (2)
Changes in quality of life and function using Functional Assessment of Cancer Therapy - General (FACT-G) survey
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.
Measured: Screening and daily from Day 1 to Day 10
Changes in quality of life and function based on number of steps
Changes in quality of life and function during the study based on the number of steps per day by an activity tracker.
Measured: Daily from Day 1 to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start3 Jun 2025
- Primary completion3 Jun 2027 (estimated)
- Study completion3 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Abott Lingo Wearables, United States Department of Defense, Prostate Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Laura Sena, MD, PhD, Principal investigator, SKCCC Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826924
- Sponsor's protocol ID
- J2487
- Other IDs
- IRB00456089
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of 7-days Water-only Fasting or Ketone Supplementation in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT06826924
- Acronym / sponsor ID
- J2487
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Keywords
- fasting, ketone supplementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Abott Lingo Wearables, United States Department of Defense, Prostate Cancer Foundation
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 3 Jun 2027 (estimated)
- Study completion
- 3 Jun 2027 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fasting with Local Prostate Cancer | Experimental | Behavioral: Fasting7-day water-only fast followed by a 3-day refeeding |
| Ketone Supplementation with Local Prostate Cancer | Experimental | Dietary Supplement: Ketone Supplementation7-day ketone supplementation |
| Fasting with Metastatic Prostate Cancer | Experimental | Behavioral: Fasting7-day water-only fast followed by a 3-day refeeding |
| Ketone Supplementation with Metastatic Prostate Cancer | Experimental | Dietary Supplement: Ketone Supplementation7-day ketone supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting7 days of water-only fasting | Behavioural | Fasting with Local Prostate Cancer, Fasting with Metastatic Prostate Cancer |
| Ketone Supplementation7 days of ketone supplementation | Dietary supplement | Ketone Supplementation with Local Prostate Cancer, Ketone Supplementation with Metastatic Prostate Cancer |
Primary outcome
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
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.
2 secondary outcomes
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 based on number of steps
Time frame: Daily from Day 1 to Day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Sena, MD, PhD principal investigator
SKCCC Johns Hopkins Medical Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting and Ketone Supplementation in people with Prostate Cancer and Prostate Cancer Metastatic, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Sena, MD, PhD (410-502-3825, laura.sena@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events and serious adverse events (SAEs) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.