Whole-Food Plant-Based Diet for Prostate Cancer

(WFPBD Trial)

Recruiting at 2 trial locations

Overseen By David Nanus, M.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must be taking: Androgen deprivation therapy

Must not be taking: Warfarin

Disqualifiers: Insulin-dependent diabetes, Nut allergy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 26 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a whole-food, plant-based diet might help men with prostate cancer undergoing androgen-deprivation therapy (ADT) manage their weight. Participants will either receive home-delivered plant-based meals and coaching or general nutritional advice (also known as general nutritional counseling). Men with prostate cancer who have been on ADT for at least six months and have a BMI of 27 or higher might be suitable candidates. As an unphased trial, participants can contribute to innovative research that could enhance dietary recommendations for prostate cancer patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that there should be no expected changes in chronic medications, including statins or oral diabetes medication, during the study period. This suggests you should continue your current medications without changes.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that a whole-food, plant-based diet is generally safe and easy to follow. Studies have found that eating more plant-based foods links to a lower risk of aggressive prostate cancer. In a large study of over 2,000 men with prostate cancer, those who ate more plant foods after their diagnosis had a lower risk of their cancer worsening. Another study found that following a healthy plant-based diet linked to a lower risk of cancer and related health issues.

These findings suggest that a whole-food, plant-based diet is not only safe but may also offer health benefits for those with prostate cancer. No specific reports of serious side effects have emerged from following this diet, making it a promising option for people seeking new ways to support their treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for prostate cancer, which often involve surgery, radiation, or hormone therapy, a Whole-food, Plant-Based Diet (WFPBD) offers a non-invasive approach. Researchers are excited about this method because it emphasizes dietary changes that may improve overall health and well-being without the side effects associated with conventional treatments. This diet focuses on natural, whole foods, potentially reducing inflammation and supporting the body’s natural defenses. Additionally, the inclusion of nutritional coaching and education empowers participants to make lasting lifestyle changes, which might contribute to better long-term health outcomes.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research shows that a diet focused on whole, plant-based foods can benefit people with prostate cancer. In this trial, one group of participants will follow a Whole-food, Plant-Based Diet (WFPBD), receiving home-delivered meals and nutritional coaching. Studies have found that eating more fruits, nuts, and vegetables, while reducing animal products, links to nearly a 50% lower risk of developing prostate cancer. Additionally, a healthier plant-based diet connects to a much lower chance of having high levels of prostate-specific antigen (PSA), which can indicate prostate cancer. Eating plant-based foods also associates with a better quality of life for those with prostate cancer. Overall, avoiding red and processed meats, dairy, and alcohol, while focusing on plant-based foods, has strong evidence supporting improved cancer outcomes. Another group in this trial will receive general nutritional counseling, providing a comparison to evaluate the specific benefits of the WFPBD. ^{1 2 6 7 8}

Who Is on the Research Team?

David M Nanus, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

Men over 45 with prostate cancer on androgen-deprivation therapy for at least 24 weeks, who are not currently vegetarian or vegan, without recent chemo/radiation, and no plans to change exercise habits. They must have a good performance status (able to carry out daily activities), adequate organ function, no nut/legume/gluten allergies, and be willing to follow the study procedures.

Inclusion Criteria

I am taking medications for bone health.

I am on hormone therapy for prostate cancer or have had surgery to remove my testicles.

I am willing and able to follow all study procedures.

Exclusion Criteria

I am not expected to start any major cancer treatments like radiation or chemotherapy within 2 months of starting the diet plan.

You are currently following a vegetarian or vegan diet.

You have allergies to nuts, legumes, or gluten, or you have celiac disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive home-delivered whole-food, plant-based meals and nutritional coaching. 12 meals a week for the first 4 weeks, followed by 6 meals a week for the next 4 weeks, and self-prepared WFPBD for 18 weeks.

26 weeks

Weekly visits for the first 4 weeks, then monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in weight, inflammation markers, and quality of life.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• General Nutritional Counseling
• Whole-food, Plant-Based Diet

Trial Overview

The trial is testing if home-delivered whole-food plant-based meals help control weight better than standard nutritional counseling in overweight men with prostate cancer undergoing hormone therapy.

How Is the Trial Designed?

Group I: Whole-food, Plant-based Diet (WFPBD) Experimental Treatment 1 Intervention

Home-delivered WFPBD meals will be provided to participants, along with nutritional coaching and education. 12 meals a week will be delivered for the first 4 weeks, followed by 6 meals a week for the next 4 weeks. Finally, for the last 18 weeks they will not receive pre-packed meals, but will continue to receive WFPBD coaching. 30 participants are anticipated to be accrued in this arm.

Group II: General Nutrition Counseling Active Control 1 Intervention

Participants will receive general nutritional counseling weekly for the first 4 weeks, followed by monthly nutritional counseling for the following 18 weeks. 30 participants are anticipated to be accrued in this arm.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

CookUnity

Collaborator

Trials

1

Recruited

60+

Plantable Inc.

Collaborator

Trials

1

Recruited

60+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

Published Research Related to This Trial

Interventional studies involving plant-based diets for men with localized prostate cancer showed improvements in short-term oncologic outcomes and overall health, indicating potential benefits of lifestyle modifications.

Observational studies suggested that plant-based dietary patterns may be associated with a lower risk of prostate cancer, particularly with vegan diets, although some studies reported no significant difference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the impact of a plant-based diet on prostate cancer incidence and outcomes. Gupta, N., Patel, HD., Taylor, J., et al.[2023]

Plant-based and plant-forward diets, such as the Mediterranean diet, may offer protective benefits against common men's health issues like prostate cancer, erectile dysfunction, and benign prostatic hyperplasia, based on a systematic review of 24 studies.

While the evidence is not yet robust, the literature indicates a consistent small beneficial impact of these diets on men's health conditions, alongside their known advantages for other chronic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should Men Eat More Plants? A Systematic Review of the Literature on the Effect of Plant-Forward Diets on Men's Health. Feiertag, N., Tawfik, MM., Loloi, J., et al.[2023]

Vegetarian diets may lower the risk of prostate cancer, but the specific role of dietary fiber is unclear due to the antioxidant properties of plant foods.

A proposed nutritional approach, including a diet with low fat, high fiber, and 40 g of soybean protein daily, is being studied as a potential strategy for managing prostate cancer, although more rigorous large-scale studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cancer of the prostate: influence of nutritional factors. A new nutritional approach]. de la Taille, A., Katz, A., Vacherot, F., et al.[2017]

In a study of 47,239 men over 28 years, higher consumption of healthful plant-based diets was linked to a significantly lower risk of fatal prostate cancer, particularly in men under 65 years old.

Men under 65 who followed a plant-based diet had reduced risks of advanced and lethal prostate cancer, suggesting that plant-based eating patterns may be protective against aggressive forms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of plant-based diet index with prostate cancer risk. Loeb, S., Fu, BC., Bauer, SR., et al.[2023]

Certain dietary components, such as green tea, isoflavones, lycopenes, cruciferous vegetables, and omega-3 fatty acids, may help prevent or slow the progression of prostate cancer, according to a review of existing studies.

Conversely, high intake of total fat, well-cooked meat, and multivitamins may increase the risk of developing prostate cancer, highlighting the need for more rigorous research to clarify these dietary impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer and diet: food for thought? Hori, S., Butler, E., McLoughlin, J.[2022]

A pilot clinical trial showed that patients with recurrent prostate cancer could successfully adopt and maintain a plant-based diet over 6 months, significantly increasing their intake of whole grains and vegetables.

The study found a decrease in the rate of PSA rise, an indicator of disease progression, during the first 3 months of dietary intervention, suggesting that a plant-based diet may have therapeutic potential in managing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption of a plant-based diet by patients with recurrent prostate cancer. Nguyen, JY., Major, JM., Knott, CJ., et al.[2016]

A review of 25 studies, including 8 observational and 17 intervention trials, suggests that plant-based diets may positively influence the progression and clinical outcomes of prostate cancer.

While more long-term clinical trials are necessary, early findings indicate that encouraging patients to adopt plant-based diets could be a valuable part of their treatment plan for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and survival after prostate cancer diagnosis. Berkow, SE., Barnard, ND., Saxe, GA., et al.[2019]

A minimally processed, plant-based diet rich in fiber, vitamins, and phytonutrients is linked to better prostate health and lower prostate cancer risk, as indicated by PSA levels.

Dietary changes that positively affect the gut microbiome may play a crucial role in reducing androgen exposure to the prostate, which could help lower the risk and progression of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Cancer Risk Connection to Immunity, Hormones, and the Microbiome. Bland, JS.[2022]

A study of 118 prostate cancer patients found that a healthy plant-based diet is associated with a lower likelihood of severe prostate cancer, with significant odds ratios indicating reduced risk for medium/high and high-risk cases.

Conversely, higher adherence to an unhealthy plant-based diet was linked to a greater risk of severe prostate cancer, suggesting that the quality of plant-based foods matters significantly in cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Healthy or Unhealthy Pro-Vegetarian Plant-Based Diets Have Different Impact on Prostate Cancer Severity: Preliminary Findings. Sciacca, S., Lo Giudice, A., Asmundo, MG., et al.[2023]

A diet rich in protective elements like tomatoes, cruciferous vegetables, and omega-3 fatty acids may help reduce the risk of prostate cancer, while high intakes of dairy, saturated fats, and grilled meats could increase risk.

Current evidence suggests that a balanced diet with a variety of plant-based foods and fish is advisable for prostate cancer prevention, although more clinical trials are needed to confirm the effects of specific nutrients and supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of diet in prostate cancer development and progression. Chan, JM., Gann, PH., Giovannucci, EL.[2005]

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