Intermittent Fasting for Prostate Cancer

Overseen By Kyle Pasquariello

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Must be taking: Androgen deprivation

Disqualifiers: Other malignancy, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether intermittent fasting (abstaining from food for 16 hours a day) can effectively complement prostate cancer treatment, particularly for those undergoing androgen deprivation therapy. Researchers aim to determine if participants can adhere to this fasting routine and if it aids in cancer management. Men with prostate cancer eligible for androgen deprivation therapy and willing to commit to fasting may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve prostate cancer treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that people generally find intermittent fasting easy to handle. Some studies have found that it can improve overall health and slow cancer growth. For instance, trials using a diet that mimics fasting have shown positive health effects.

One study discovered that fasting every other day might lower certain protein levels in prostate cancer tumors, potentially aiding in cancer treatment. Importantly, participants did not report any major side effects.

In summary, current evidence suggests that intermittent fasting is safe, with usually manageable side effects. However, individual experiences can differ, so consulting a healthcare provider before starting any fasting plan is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Intermittent fasting is unique because it offers a non-invasive approach to managing prostate cancer, which is different from the standard treatments like surgery, radiation, or hormone therapy. Researchers are excited about this approach because it leverages the body's natural processes to potentially slow cancer growth by reducing insulin levels and inflammation, which are linked to cancer progression. Additionally, incorporating a plant-based diet during fasting could further enhance benefits by providing essential nutrients while avoiding the side effects often associated with more aggressive treatments.

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

Research has shown that intermittent fasting, which participants in this trial will undergo, might help manage prostate cancer. Studies have found that fasting every other day can lower certain nutrients and proteins in prostate cancer tumors, potentially slowing their growth. In mice, fasting twice a week slowed tumor growth. Additionally, time-restricted eating, another type of intermittent fasting, has proven feasible for cancer patients and might offer cancer-fighting benefits while improving their quality of life. These findings suggest that intermittent fasting could be a promising option for people with prostate cancer. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for prostate cancer patients who are currently undergoing androgen deprivation therapy. It's designed to see if they can stick to a schedule of intermittent fasting, with the option to follow a plant-enriched diet.

Inclusion Criteria

My organ functions are within normal ranges as per recent tests.

Subjects must have a life expectancy of at least 6 months

I have prostate cancer that can be measured and I am eligible for hormone therapy.

Exclusion Criteria

I cannot or will not sign the consent form for this trial.

I have not been in a clinical trial for a new treatment or device in the last 4 weeks.

I need assistance with my daily activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intermittent fasting with optional plant-enriched diet while receiving androgen deprivation therapy

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Fasting

Trial Overview

The study is testing whether intermittent fasting (with or without a plant-enriched diet) is practical for these patients. The focus is on how well participants can enroll, stay in the study, and follow the dietary guidelines.

How Is the Trial Designed?

Group I: Intermittent Fasting Experimental Treatment 1 Intervention

Patients will undergo 16h periods of fasting everyday. Optionally, patients will be offered to undergo a plant-based diet consisting of 20% plant based protein, 50% carbohydrates, and 30% fat for the duration of the study.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Published Research Related to This Trial

In a study involving 160 male SCID mice with prostate cancer, a 20% carbohydrate diet significantly slowed tumor growth compared to a western diet, suggesting dietary modifications may impact cancer progression.

While survival rates did not significantly differ among the various carbohydrate-restricted diets, there was a non-significant trend indicating improved survival for those on carbohydrate-restricted diets compared to the western diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of carbohydrate restriction on prostate cancer tumor growth in a castrate mouse xenograft model. Caso, J., Masko, EM., Ii, JA., et al.[2021]

In a pilot study involving 105 male SCID mice with prostate cancer, intermittent fasting regimens showed non-significant trends toward improved survival compared to a control group, suggesting potential benefits of fasting in cancer management.

Mice on certain fasting diets had significantly lower body weights and IGF-1 levels, indicating that these dietary interventions may influence cancer growth mechanisms, although no significant survival differences were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intermittent fasting with or without caloric restriction on prostate cancer growth and survival in SCID mice. Buschemeyer, WC., Klink, JC., Mavropoulos, JC., et al.[2010]

A study is being conducted to explore the effects of alternate day fasting (ADF) on healthy non-obese individuals, involving 90 participants, with some having followed ADF for at least 6 months and others starting ADF for 4 weeks.

The research aims to assess various health parameters, including metabolic and cardiovascular effects, using advanced techniques like echocardiography and glucose monitoring, to better understand the physiological impacts of ADF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial. Tripolt, NJ., Stekovic, S., Aberer, F., et al.[2022]

Modified alternate-day fasting (ADF) significantly reduces cell proliferation rates in various tissues, regardless of whether the diet is low-fat or high-fat, suggesting its potential as a cancer prevention strategy.

In a 4-week study with male mice, both ADF groups showed similar reductions in T-cell proliferation and decreased plasma insulin-like growth factor-1 levels, indicating that ADF can be effective across different dietary fat intakes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate-day fasting reduces global cell proliferation rates independently of dietary fat content in mice. Varady, KA., Roohk, DJ., Bruss, M., et al.[2009]

Fasting may enhance cancer treatment effectiveness and reduce side effects by creating conditions that hinder cancer cell survival and growth, as suggested by emerging evidence.

The review emphasizes the need for an integrated understanding of how fasting interacts with cancer therapies, recommending the combination of prolonged periodic fasting with standard treatments to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of fasting on cancer: A narrative review of scientific evidence. Tiwari, S., Sapkota, N., Han, Z.[2022]

In an 8-week study with 59 obese participants, alternate day fasting (ADF) led to a significant weight loss of 4.2%, while only a small percentage reported mild adverse effects like constipation and dizziness.

ADF was associated with improvements in eating disorder symptoms, including a decrease in depression and binge eating, suggesting that it may have beneficial effects on body image and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. Hoddy, KK., Kroeger, CM., Trepanowski, JF., et al.[2018]

In a study involving 100 mice with prostate cancer, intermittent fasting (IF) did not improve survival rates or delay tumor growth compared to a regular diet, indicating that this approach may not be effective for cancer treatment in this model.

Despite the lack of survival benefits, mice undergoing IF showed significantly higher levels of IGF-1, suggesting that metabolic changes during fasting may counteract potential anti-cancer effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intermittent fasting on prostate cancer tumor growth in a mouse model. Thomas, JA., Antonelli, JA., Lloyd, JC., et al.[2010]

In a 4-week study with 24 male mice, the modified alternate-day fasting (ADF-100%) regimen significantly reduced prostate cell proliferation by 49% and T-cell proliferation by 30%, indicating a potential decrease in cancer risk.

The ADF-100% group also showed a 40% reduction in circulating insulin-like growth factor-1 (IGF-1) levels, which is associated with lower cancer risk, while other modified ADF regimens (ADF-25% and ADF-50%) did not produce similar effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose effects of modified alternate-day fasting regimens on in vivo cell proliferation and plasma insulin-like growth factor-1 in mice. Varady, KA., Roohk, DJ., Hellerstein, MK.[2015]

Citations

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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 ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05832086

Study Details | NCT05832086 | Intermittent Fasting Using a ...

This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05722288

NCT05722288 | Time-Restricted Eating Versus Nutritional ...

This phase II trial studies how well time-restricted eating works in reducing side effects of radiation or chemoradiation side effects when compared to ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3680567/

Intermittent fasting: the science of going without - PMC

... effects of intermittent fasting on prostate cancer growth in mice (Prostate Cancer Prostatic Dis 2010; 13:350–5). In the study, mice fasted twice a week for ...

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academic.oup.com

academic.oup.com/nutritionreviews/article/83/7/e1660/7745808

Clinical Impact of Time-restricted Eating on Cancer

Preliminary findings suggest that TRE is feasible and acceptable by people with cancer, may have oncological benefits, and improves quality of life.

6.

reporter.nih.gov

reporter.nih.gov/search/RlrQnUyTvU2-8RtHa1q1rA/project-details/10871888

Project Details

Data from our team has shown that intermittent fasting using a fasting mimicking diet (FMD) can improve metabolic health in people and delay cancer progression ...

7.

prevention.cancer.gov

prevention.cancer.gov/clinical-trials/clinical-trials-search/nct05832086

Intermittent Fasting Using a Fasting-Mimicking Diet to Improve ...

This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma.