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

NCT07220499 | Completed

• 1 other identifier: PCC-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

whole food plant-based diet

Outcome Measures

Primary Outcomes (1)

• Prostate Specific Antigen

  6 months

Secondary Outcomes (3)

• LDL-cholesterol

  6 months

• Hemoglobin A1C

  6 months

• high sensitivity C-reactive protein

  6 months

Other Outcomes (2)

• Plasma insulin-like growth factor 1

  6 months

• Plasma insulin like growth factor binding protein 3

  6 months

Study Arms (1)

Whole Food Plant-based Diet

EXPERIMENTAL

Other: Whole Food Plant-based Diet

Interventions

Whole Food Plant-based Diet OTHER

6-months of a predominately whole food plant-based diet

Whole Food Plant-based Diet

Eligibility Criteria

• Age: 45 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pacific Cancer Care: lead

Study Sites (1)

Pacific Cancer Care

Monterey, California, 93940, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• John Hausdorff, MD

  Pacific Cancer Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 24, 2025
• Study Start: November 7, 2023
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)