Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer

M.D. Anderson Cancer Center

Status: Invitation-only

Conditions: Prostate Cancer

Treatments: Behavioral: Mediterranean diet-based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06935097

2025-0331

NCI-2025-02780 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Primary Objectives:

To determine the feasibility of a Mediterranean diet-based intervention adapted for underrepresented minority men with prostate cancer, defined based on the following process measures68:

• Enrollment (completion of 25 patient accrual within 2 years)
• Retention (completion of the study through the 6-month time point, with ≥80% defined as successful)
• Adherence (the percentage of completed study sessions and clinic visits, with ≥70% considered successful).

Secondary Objectives:

To determine changes due to the Mediterranean diet intervention in the following measures:

• Mediterranean diet score (define using MEPA I calculated using VioScreen data)
• Weight/BMI
• QoL (EQ-5D-5L)
• Physical activity (IPAS)
• Non-invasive biomarkers
• Gut microbiome
• Metabolomics

To determine fidelity of intervention,62 including a description of patient comprehension, cognitive skills and perceived ability to change diet during the intervention.

Enrollment: 25 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Intervention with Mediterranean Diet

Experimental group

Description:

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).

Treatment:

Behavioral: Mediterranean diet-based Intervention