Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06935097
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Detailed 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 FFQ data)

* Weight/BMI

* QoL (EQ-5D-5L)

* Physical activity (IPAS)

* Non-invasive biomarkers

* Gut microbiome

* Metabolomics

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Study Start: 2025-10-01
• Primary Completion: 2027-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 25

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
• Inability to complete a food record
• Unwillingness to participate in study activities
• Inability to keep appointments
• Food allergy prohibitive of a Mediterranean diet, i.e. nuts allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and Adverse Events (AEs)	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0