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?

This trial explores whether fasting or a very low-calorie diet can help the immune system combat metastatic prostate cancer. Researchers aim to determine if a 7-day water-only fast or a very low-calorie diet is safe and feasible for individuals with advanced prostate cancer. Ideal participants have been diagnosed with metastatic prostate cancer, have not experienced a recent drop in prostate-specific antigen (PSA) levels, and have a body mass index (BMI) between 20 and 35. The findings will guide future studies on enhancing cancer treatment outcomes through fasting. As an unphased trial, this study offers patients a unique opportunity to contribute to groundbreaking research that could shape future cancer treatments.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop taking steroids, diuretics, and beta blockers at least two weeks before joining. If you can't stop taking steroids, you won't be eligible to participate.

What prior data suggests that fasting is safe for patients with metastatic prostate cancer?

Research has shown that fasting is safe for healthy adults. Animal studies have found that fasting helps the immune system fight cancer. Some research also suggests that fasting might enhance prostate cancer treatments by lowering certain proteins that tumors need to grow.

Moreover, a special low-calorie diet similar to fasting has been found safe and might improve health in cancer patients. However, more studies are needed to understand its specific effects on prostate cancer.

These findings suggest that fasting could be a safe option for people with advanced prostate cancer, but more research in humans is needed to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about fasting as a treatment for prostate cancer because it offers a unique, non-invasive approach compared to traditional options like surgery, radiation, and hormone therapy. Unlike these treatments, which target cancer cells directly, fasting may work by altering the body’s metabolic processes, potentially reducing the growth of cancer cells by depriving them of nutrients. Additionally, fasting is a natural intervention that may have fewer side effects, making it an appealing option for patients seeking alternative therapies.

What evidence suggests that fasting might be an effective treatment for prostate cancer?

Research shows that fasting might help fight prostate cancer in unique ways. Studies have found that fasting every other day can lower certain amino acids and slow protein production in prostate tumors, potentially weakening them. Fasting also reduces levels of insulin growth factor (IGF-1), a hormone linked to cancer risk, and strengthens the body's natural defenses. Additionally, fasting alters how the body uses energy, which may slow cancer growth. This trial will specifically evaluate the effects of a 7-day water-only fast followed by a 3-day refeeding period. These findings suggest that fasting could be a useful addition to prostate cancer treatment. ^{3 4 5 6 7}

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

Citations

1. medicine.buffalo.edu medicine.buffalo.edu/news_and_events/news/2025/8/pili-prostate-cancer-fasting-22923.html

Study: In Prostate Cancer, Intermittent Fasting Found to ... The results demonstrate that alternate-day fasting reduced amino acid levels and global protein synthesis within prostate cancer tumors, making ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7824351/

Eight Days of Water-Only Fasting Promotes Favorable ... The results showed that after 8 days of water-only fasting, Qmax and IPSS improved but PV and TTV decreased significantly. There was also a decrease in blood ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06826924

7-Days Water-Only Fasting Trial in Prostate Cancer The primary objective of this study is to determine if 7 days of water-only fasting or a ketogenic very low-calorie diet is safe and feasible in patients with ...

4. cedars-sinai.org cedars-sinai.org/discoveries/fasting-as-next-step-in-cancer-treatment.html

Researchers Look to Fasting as a Next Step in Cancer ... Studies show that fasting reduces insulin growth factor (IGF-1) levels, a marker for increased cancer risk, boosts normal cells' defenses and ...

5. nature.com nature.com/articles/s41391-022-00528-3

The impact of a fasting mimicking diet on the metabolic ... Fasting results in nutritional ketosis which promotes potent changes in metabolic pathways, which may result in cancer growth reduction, not ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06826924

7-Days Water-Only Fasting Trial in Prostate Cancer Seven days of water-only fasting is safe and feasible in healthy adults. Fasting enhances anti-tumor immunity in animal models of cancer. The primary objective ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9530862/

Effect of Fasting on Cancer: A Narrative Review Emerging evidence suggests that fasting could play a key role in cancer treatment by fostering conditions that limit cancer cells' adaptability, survival, and ...