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

NCT06826924 | Recruiting DMC

• 2 other identifiers: J2487IRB00456089
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Cancer Metastatic

Keywords

fasting; ketone supplementation

Outcome Measures

Primary Outcomes (2)

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

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

  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.

  1 year

Secondary Outcomes (2)

• Changes in quality of life and function using Functional Assessment of Cancer Therapy - General (FACT-G) survey

  Screening and daily from Day 1 to Day 10

• Changes in quality of life and function based on number of steps

  Daily from Day 1 to Day 10

Study Arms (4)

Fasting with Local Prostate Cancer

EXPERIMENTAL

7-day water-only fast followed by a 3-day refeeding

Behavioral: Fasting

Ketone Supplementation with Local Prostate Cancer

EXPERIMENTAL

7-day ketone supplementation

Dietary Supplement: Ketone Supplementation

Fasting with Metastatic Prostate Cancer

EXPERIMENTAL

7-day water-only fast followed by a 3-day refeeding

Behavioral: Fasting

Ketone Supplementation with Metastatic Prostate Cancer

EXPERIMENTAL

7-day ketone supplementation

Dietary Supplement: Ketone Supplementation

Interventions

Fasting BEHAVIORAL

7 days of water-only fasting

Fasting with Local Prostate Cancer; Fasting with Metastatic Prostate Cancer

Ketone Supplementation DIETARY_SUPPLEMENT

7 days of ketone supplementation

Ketone Supplementation with Local Prostate Cancer; Ketone Supplementation with Metastatic Prostate Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• United States Department of Defense: collaborator
• Prostate Cancer Foundation: collaborator
• Abott Lingo Wearables: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• Laura Sena, MD, PhD

  SKCCC Johns Hopkins Medical Institution

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Sena, MD, PhD

CONTACT

410-502-3825; laura.sena@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): June 3, 2027
• Study Completion (Estimated): June 3, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

US (1)