Fasting for Prostate Cancer

Overseen By Sin Chan, MS

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Immunosuppressants, Steroids, Diuretics, others

Disqualifiers: Diabetes, Cardiac arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Laura Sena, MD, PhD

Principal Investigator

SKCCC Johns Hopkins Medical Institution

Are You a Good Fit for This Trial?

This trial is for men with metastatic prostate cancer who have a soft tissue metastasis that can be biopsied, stable PSA levels, and a BMI between 20-35. They may have had previous cancer treatments if it's been over 2 weeks since the last dose. Steroid treatment must also be more than 2 weeks prior, unless they cannot stop taking them. Participants should have normal bilirubin and liver enzyme levels and be in good physical condition (ECOG status of 0 or 1).

Inclusion Criteria

I haven't taken steroids in the last 2 weeks and don't need them to manage my condition.

My bilirubin levels are less than 2.5 times the normal limit.

I have had prostate cancer treatment, but it was over 2 weeks ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Fasting

Participants undergo a 7-day water-only fast or a ketogenic very low-calorie diet

7 days

Clinic visit on Day 3

Refeeding

Participants follow a 3-day refeeding protocol to evaluate safety and feasibility

3 days

Follow-up

Participants are monitored for safety and effectiveness after fasting and refeeding

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Fasting

Trial Overview The study is testing whether a week-long water-only fast or very low-calorie diet is safe and doable for patients with advanced prostate cancer. The goal is to see if fasting can reset metabolism and immune function to help fight cancer cells, which could lead to better future treatments.

How Is the Trial Designed?

Group I: Fasting Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

Abott Lingo Wearables

Collaborator