Whole Food Plant-based Diet to Improve Outcomes in Prostate Cancer

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

The purpose of this research is to determine if consuming a whole food plant-based diet for six months impacts outcomes in men with prostate cancer that have a rising prostate-specific antigen (PSA) level. The main questions it aims to answer are: Does a whole-food plant-based impact PSA? Does a whole food plant-based diet impact risk factors associated with treatment for prostate cancer including LDL cholesterol, hemoglobin A1C, C-reactive protein? Participants will be asked to attend twelve two-hour plant-based cooking and nutrition classes throughout a six-month period, consume a mostly whole food plant-based diet, provide blood samples, and complete three-day food journals to assess nutrient intake.

Key facts

Study ID

NCT07220499

Run by

Pacific Cancer Care

People needed

11

Starts

2023-11-07

Expected to finish

2025-09-25

Last updated by the study team

2025-10-24

Who can join

Age: 45 and older, up to 99. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males 45-99 years of age
• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Increasing PSA on at least 2 sequential tests not more than 6 months apart.
• Eastern Cooperative Oncology Group Performance Status Scale of 0 to 2
• Adequate organ and marrow function, based upon meeting all of the following laboratory criteria:
• White blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L)
• Platelets ≥ 50,000/mm3 (≥ 100 GI/L) without transfusion
• Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≤ 2x upper limit of normal (or for subjects with Gilbert's syndrome direct bilirubin WNL) Serum albumin ≥ 2.8 g/dl
• Willingness and ability to comply with all study-related procedures
• Capable of understanding and complying with the protocol requirements and must have signed the informed consent document

You may not qualify if…

• Nut or legume allergy
• Currently consuming a vegetarian or vegan diet
• Concurrent participation in other nutrition or weight loss programs
• Expected changes in exercise patterns during the study period
• Active prostatitis
• Insulin-dependent or requiring diabetes mellitus
• Expected changes in chronic medications, including statins or oral diabetes medication during the study period (including a change in medication dosage)
• Expected radiation, chemotherapy, bone resorptive agents or anti-androgen within 2 months of beginning the diet intervention
• Known history of electrolyte imbalance or micronutrient deficiency, e.g., magnesium, cobalamin
• Ongoing use of warfarin anticoagulants
• Diagnosed, active inflammatory bowel disease
• Alcohol and/or drug abuse
• Psychiatric illnesses or social situations that would limit compliance with study requirements including the inability or lack of equipment to perform basic cooking tasks

Where it is running

• Pacific Cancer Care — Monterey, California, United States

Full record on ClinicalTrials.gov

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