RECRUITING

7-Days Water-Only Fasting Trial in Prostate Cancer

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Conditions

Metastatic Prostate Cancerfasting

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. The purpose of this study is to determine whether 7 days of water-only fasting or a very low-calorie diet is safe and feasible for patients with metastatic prostate cancer. This will help the investigators develop future studies to test whether incorporating periods of fasting or very low calorie diets into treatment plans for prostate cancer can improve outcomes from this disease.

Official Title

A Study of 7-days Water-only Fasting in Patients With Metastatic Prostate Cancer

Quick Facts

Study Start:2025-06-03
Study Completion:2026-06-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06826924

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  2. 2. Age ≥18 years
  3. 3. Diagnosis of metastatic adenocarcinoma of the prostate
  4. 4. Must have a soft tissue metastasis amenable to biopsy
  5. 5. 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.
  6. 6. BMI between 20 and 35 kg/m2
  7. 7. 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.
  8. 8. Prior treatment with steroids is permitted if \>2 weeks from last dose. Patients who cannot be weaned off steroids are not eligible.
  9. 9. Acceptable liver function:
  10. 1. Bilirubin \< 2.5 times institutional upper limit of normal (ULN)
  11. 2. Aspartate transaminase (AST) (SGOT) and Alanine transaminase (ALT) (SGPT) \< 2.5 times ULN
  12. 10. 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.com
  13. 11. Acceptable hematologic status:
  14. 1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L)
  15. 2. Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)
  16. 3. Hemoglobin ≥ 8 g/dL.
  17. 12. Acceptable electrolyte and acid/base status:
  18. 1. Sodium 135-148 millimoles (mM) per litre
  19. 2. Potassium 3.5-5.1mM
  20. 3. Carbon Dioxide 21-31mM
  21. 4. Phosphorus 2.7-4.5mM
  22. 5. Magnesium ≥1.6mM
  23. 6. Lactate ≤2mM
  24. 13. Ability to understand and willingness to sign a written informed consent document
  1. 1. ECOG Performance status ≥2
  2. 2. Unintentional weight loss greater than or equal to 5% in previous 3 months
  3. 3. Diabetes mellitus, defined as HbA1c ≥6.5% or use of medications for diabetes
  4. 4. Active uncontrolled infection. Patients with a history of HIV/AIDS may be eligible if cluster of differentiation 4 (CD4)+ T cell counts are ≥ 350 cell/ul, the patient have had no opportunistic infection within the past 12 months, the patient 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 patient have completed curative antiviral treatment and the HCV viral load is below the limit of quantification.
  5. 5. Use of immunosuppressive medications including steroids
  6. 6. Use of diuretics or beta blockers
  7. 7. History of cardiac arrythmia, myocardial infarction, valvular heart disease, or pulmonary hypertension
  8. 8. Abnormal screening EKG
  9. 9. Daily alcohol consumption
  10. 10. 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

Contacts and Locations

Study Contact

Laura Sena, MD, PhD
CONTACT
410-502-3825
laura.sena@jhmi.edu

Principal Investigator

Laura Sena, MD, PhD
PRINCIPAL_INVESTIGATOR
SKCCC Johns Hopkins Medical Institution

Study Locations (Sites)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Laura Sena, MD, PhD, PRINCIPAL_INVESTIGATOR, SKCCC Johns Hopkins Medical Institution

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-03
Study Completion Date2026-06-03

Study Record Updates

Study Start Date2025-06-03
Study Completion Date2026-06-03

Terms related to this study

Keywords Provided by Researchers

  • fasting

Additional Relevant MeSH Terms

  • Metastatic Prostate Cancer