Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer

Running, not enrolling · Not applicable

Conditions studied: Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8

In brief

This clinical trial studies the effects of a dietary intervention prior to surgery (neoadjuvant) in patients with intermediate risk prostate cancer. Changing your diet before surgery may help to improve overall health. Information from this study may help researchers better understand the influence of diet on the outcomes of patients with intermediate prostate cancer.

Key facts

Study ID

NCT04985565

Run by

M.D. Anderson Cancer Center

People needed

12

Starts

2021-08-27

Expected to finish

2026-10-20

Last updated by the study team

2026-04-09

Who can join

Age: 30 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed adenocarcinoma of the prostate that is localized based on prostate magnetic resonance imaging (MRI) and meets National Comprehensive Cancer Network (NCCN) intermediate risk criteria (as follows):
• Clinical T2b-T2c or lower disease
• Gleason Grade group 2 or 3 on biopsy
• Prostate specific antigen (PSA) =< 20 ng/mL
• Desires radical prostatectomy (open or robotic) for prostate cancer management and is a surgical candidate as determined by the treating urologic oncologist
• Adult men > 30 and < 75 years old (African American or non-Hispanic white)
• Meet one of the following criteria for overweight or obesity:
• Body Mass Index (BMI) between 26 and 39
• Waist circumference >= 40 inches
• Willingness to exclusively consume all the provided meals
• Willingness to comply with all study procedures and scheduled visits
• Reside in the greater Houston/outlying areas and/or willing to travel for study-related visits at MD Anderson

You may not qualify if…

• Major dietary restrictions or food allergies
• Food aversions or preferences that preclude following a Mediterranean diet, such as unwillingness to eat vegetables, grains, animal products or fish
• Medical contraindications to the intervention diet as determined by the treating physician
• Current self-reported smoker or heavy drinker (defined as >14 drinks per week) or current self-reported illicit drug use
• Prostate cancer that meets NCCN high and very high risk criteria (as follows):
• pT3a or higher disease
• Grade group 4 or 5 adenocarcinoma of prostate
• PSA > 20ng/mL

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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