Status:
COMPLETED
Whole Food Plant-based Diet to Improve Outcomes in Prostate Cancer
Lead Sponsor:
Pacific Cancer Care
Conditions:
Prostate Cancer
Eligibility:
MALE
45-99 years
Phase:
NA
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) l...
Detailed Description
Ten men with histologically or cytologically confirmed adenocarcinoma of the prostate will be recruited from local urologists and oncologists. Eligible participants will be asymptomatic with a rising ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2025
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT07220499
Start Date
November 7 2023
End Date
September 25 2025
Last Update
October 24 2025
Active Locations (1)
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1
Pacific Cancer Care
Monterey, California, United States, 93940