NCT07220499Completed
Whole Food Plant-based Diet to Improve Outcomes in Prostate Cancer
Source: ClinicalTrials.gov · Last updated 24 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 21 Oct 2025
- Start date
- 7 Nov 2023
- Primary completion date
- 25 Sept 2025
- Lead sponsor
- Pacific Cancer Care
- Diseases
- Prostate cancer
- NCT number
- NCT07220499
What you commit to
- Study type: Interventional
- Participants enrolled: 11
- From 7 Nov 2023 to the primary completion date, 25 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in other nutrition or weight loss programs
- Expected radiation, chemotherapy, bone resorptive agents or anti-androgen within 2 months of beginning the diet intervention
- Alcohol and/or drug abuse
Other illness
- Nut or legume allergy
- 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)
- Diagnosed, active inflammatory bowel disease
- Psychiatric illnesses or social situations that would limit compliance with study requirements including the inability or lack of equipment to perform basic cooking tasks
Lab values
- Known history of electrolyte imbalance or micronutrient deficiency, e.g., magnesium, cobalamin
Other
- Currently consuming a vegetarian or vegan diet
- Expected changes in exercise patterns during the study period
- Active prostatitis
- Ongoing use of warfarin anticoagulants
Who the study is looking for
- 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
Age in the registry: 45 years to 99 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pacific Cancer Care Coordinator of this site? Confirm its status | Monterey | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.