Can a Pre-Surgery diet change help prostate cancer patients?

NCT ID NCT04985565

Knowledge-focused Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study looks at whether men with intermediate-risk prostate cancer can follow a Mediterranean diet before their surgery to remove the prostate. The goal is to see if this diet is practical and well-tolerated. Twelve participants will eat specially prepared meals and then undergo standard surgery. The results will help researchers understand how diet might influence recovery and outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Mediterranean diet
What this could lead to: If successful, this could show that a dietary change before surgery is practical and may improve health outcomes for prostate cancer patients.
What could go wrong: This is a very small, early feasibility study with only 12 participants, so results may not apply broadly. The diet may be hard to follow, and the study does not directly test cancer outcomes.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

12 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 75 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

Can a Pre-Surgery diet change help prostate cancer patients?

What the study statuses mean