Whole-Food Plant-Based Diet for Prostate Cancer

(WFPBD Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by David M Nanus, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The study is comparing the effect on weight of providing home-delivered whole-food, plant-based meals versus standard, general nutritional counseling to men with prostate cancer on androgen-deprivation therapy (ADT).

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.

What data supports the effectiveness of a whole-food plant-based diet as a treatment for prostate cancer?

Research suggests that plant-based diets may help slow the progression of prostate cancer by reducing the rate of PSA (prostate-specific antigen) rise, which is a marker of cancer activity. Additionally, adhering to a healthy plant-based diet is associated with a lower risk of severe prostate cancer, while an unhealthy plant-based diet may increase the risk. ^{1 2 3 4 5}

Is a whole-food plant-based diet safe for humans?

Plant-based diets are generally considered safe and are associated with multiple health benefits, including potential protective effects against prostate cancer. They emphasize a variety of plant foods and are similar to diets recommended for heart disease prevention. ^{3 4 6 7 8}

How does a whole-food plant-based diet treatment differ from other treatments for prostate cancer?

A whole-food plant-based diet is unique because it focuses on consuming minimally processed plant foods high in fiber, vitamins, and minerals, which may improve prostate health and reduce cancer risk by influencing the gut microbiome and hormone levels. Unlike traditional treatments, this dietary approach emphasizes prevention and management through nutrition rather than medication or surgery. ^{1 3 4 9 10}

Research Team

David M Nanus, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• General Nutritional Counseling (Behavioral Intervention)
• Whole-food, Plant-Based Diet (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

CookUnity

Collaborator

Trials

1

Recruited

60+

Plantable Inc.

Collaborator

Trials

1

Recruited

60+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Adoption of a plant-based diet by patients with recurrent prostate cancer. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Diet and survival after prostate cancer diagnosis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Association of plant-based diet index with prostate cancer risk. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Adherence to Healthy or Unhealthy Pro-Vegetarian Plant-Based Diets Have Different Impact on Prostate Cancer Severity: Preliminary Findings. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Systematic review of the impact of a plant-based diet on prostate cancer incidence and outcomes. [2023]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Role of diet in prostate cancer development and progression. [2005]

9. France pubmed.ncbi.nlm.nih.gov

[Cancer of the prostate: influence of nutritional factors. A new nutritional approach]. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Prostate cancer and diet: food for thought? [2022]