Using a whole-food plant-based diet to help overweight men with prostate cancer manage weight and inflammation

Whole-Food Plant-Based Diet (WFPBD) to Control Weight and Metabo-Inflammation in Overweight/Obese Men With Prostate Cancer Receiving Androgen Deprivation Therapy (ADT): A Multi-Center Randomized Control Trial

This study is testing whether a whole-food plant-based diet can help overweight men with prostate cancer lose weight and reduce inflammation better than regular nutritional advice.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 45 Years to 99 Years
• Sex: Male
• Sponsor: Weill Medical College of Cornell University (Academic / other)
• Drugs / interventions: denosumab, chemotherapy, radiation
• Locations: 3 sites (Baltimore, Maryland and 2 other locations)
• Trial ID: NCT05471414 on ClinicalTrials.gov

What this trial studies

This study compares the effects of a home-delivered whole-food, plant-based diet (WFPBD) against standard nutritional counseling on weight management in overweight or obese men undergoing androgen deprivation therapy (ADT) for prostate cancer. Participants will receive 12 meals per week for the first 28 days, followed by 6 meals per week for another 28 days, and then self-prepared meals for 18 weeks. The study aims to assess not only weight loss but also changes in inflammation markers, metabolism, and quality of life. The hypothesis is that the WFPBD will lead to significant improvements in these areas compared to standard dietary advice.

Who should consider this trial

Good fit: Ideal candidates are overweight or obese men with histologically confirmed prostate cancer who are currently receiving androgen deprivation therapy.

Not a fit: Patients with localized prostate cancer who are not undergoing ADT or those who are not overweight may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help overweight men with prostate cancer manage their weight and reduce inflammation, potentially improving their overall health and treatment outcomes.

How similar studies have performed: Other studies have shown promising results with dietary interventions in cancer care, suggesting that this approach may be beneficial, although the specific use of a WFPBD in this context is relatively novel.

Eligibility criteria

Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma of the prostate
2. Receiving androgen deprivation therapy (ADT) with an LHRH/GnRH analogue (agonist/antagonist); or have undergone bilateral orchiectomy. Patients with localized prostate cancer, non-metastatic castrate resistant prostate cancer (CRPC), metastatic hormone sensitive prostate cancer and metastatic CRPC are all eligible.
3. On ADT for at least 24 weeks pre-study with anticipation of at least 26 more weeks of therapy from the date of initiation of the dietary intervention
4. Patients receiving an anti-androgen (including, but not limited to drugs such as bicalutamide, abiraterone, enzalutamide or apalutamide) are eligible if they have been on therapy for at least 3 months and plan to continue for the duration of the study
5. At least 3 months post completion of chemotherapy and/or radiation
6. Bone resorptive agents such as bisphosphanates and denosumab are allowed.
7. Testosterone level \<50 ng/dL
8. Age ≥ 45 years
9. BMI ≥ 27
10. ECOG performance status of 0 to 1
11. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria:

    1. White blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L)
    2. Platelets ≥ 100,000/mm3 (≥ 100 GI/L) without transfusion
    3. Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
    4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≤ 2x ULN (or for subjects with Gilbert's disease direct bilirubin WNL) Note: Subjects with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (up to 5x ULN) will be eligible if elevation is felt to be due to fatty liver disease related to obesity.
    5. Serum albumin ≥ 2.8 g/dl
12. Willingness and ability to comply with all study-related procedures
13. Capable of understanding and complying with the protocol requirements and must have signed the informed consent document

Exclusion Criteria

1. Insulin-dependent diabetes mellitus
2. Nut or legume allergy, gluten intolerance or celiac disease
3. Currently consuming a vegetarian or vegan diet
4. Concurrent participation in other nutrition or weight loss programs
5. Expected changes in chronic medications, including statins or oral diabetes medication during the study period (including a change in medication dosage)
6. Expected radiation, chemotherapy, bone resorptive agents or anti-androgen within 2 months of beginning the diet intervention
7. Expected changes in exercise patterns during the study period
8. Psychiatric illnesses or social situations that would limit compliance with study requirements, including a living situation that does not allow for the delivery of Plantable prepared meals, or the inability or lack of equipment to perform basic cooking tasks
9. Known history of electrolyte imbalance or micronutrient deficiency, e.g., magnesium, cobalamin
10. Ongoing use of warfarin anticoagulants
11. Diagnosed, active inflammatory bowel disease
12. Inability to receive Emails or have a smart phone

Where this trial is running

Baltimore, Maryland and 2 other locations

• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (Recruiting)
• Weill Cornell Medicine — New York, New York, United States (Recruiting)
• Columbia University Medical Center — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: David M Nanus, MD — Weill Medical College of Cornell University
• Study coordinator: GUONC Research Team

Conditions Prostate Cancer