Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer

NCT06935097 | Enrolling By Invitation

• 2 other identifiers: 2025-0331NCI-2025-02780
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study, we will build upon our prior work and test the feasibility of a Mediterranean diet intervention for medically underserved men with prostate cancer seen at LBJ Hospital, a large safety net facility in Harris County, TX.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Intervention with Mediterranean Diet

EXPERIMENTAL

Twenty-five (25) self-identified Black and/or Hispanic men with newly diagnosed (within 6 months) localized PCa or who have been managed on active surveillance for less than 5 years will be enrolled along with their spouses (if applicable).

Behavioral: Mediterranean diet-based Intervention

Interventions

Mediterranean diet-based Intervention BEHAVIORAL

Through existing collaboration with the Harris Health system's innovative food pharmacy, participants will be provided fresh fruit, vegetables and other foods every other week during the study. Participants will receive olive oil and walnuts during the 8 week intervention (consistent with the PREDIMED6 intervention) to supplement their (and their families') diet during the 8-week intervention (while personalized education about diet, food choices and preparation is still occurring).

Intervention with Mediterranean Diet

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate that is localized based on metastatic workup ordered by the treating physician (which may include CT scan, bone scan, MRI and/or other imaging). Note that metastatic workup is not required for enrollment.
• Diagnosis within 12 months prior to enrollment OR
• Currently managed on active surveillance, with initial biopsy being \<5 years from date of enrollment
• Self-identified Hispanic and/or Black/African American
• Patient at LBJ Hospital

You may not qualify if:

• Special dietary requirements such that patient is unwilling to attempt dietary change
• Unwillingness to participate in study activities
• Inability to keep appointments
• Food allergy prohibitive of a Mediterranean diet, i.e. nuts allergy

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

Lyndon B Johnson Hospital

Houston, Texas, 77026, United States

Location

Related Links

• MD Anderson Cancer Center Website

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

• Justin Gregg, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 20, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)