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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

• Age ≥18 years

• Diagnosis of metastatic adenocarcinoma of the prostate

• Must have a soft tissue metastasis amenable to biopsy

• 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.com

⁃ 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) per litre

∙ 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

Locations
United States
Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
RECRUITING
Baltimore
Contact Information
Primary
Laura Sena, MD, PhD
laura.sena@jhmi.edu
410-502-3825
Time Frame
Start Date: 2025-06-03
Estimated Completion Date: 2026-06-03
Participants
Target number of participants: 10
Treatments
Experimental: Fasting
7-day water-only fast followed by a 3-day refeeding
Related Therapeutic Areas
Sponsors
Collaborators: Abott Lingo Wearables
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov

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