Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer

NCT ID: NCT04985565

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-27
• Study Completion Date: 2025-10-20

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the feasibility of a neoadjuvant feeding study prior to radical prostatectomy in a racially diverse group of men diagnosed with intermediate risk prostate cancer, defined as the percentage of patients who enter the pre-intervention equilibration period and begin the dietary intervention.

SECONDARY OBJECTIVES:

I. Determine the tolerance of Mediterranean diet as defined by compliance with diet of 70% or greater total calories consumed during study period from the Mediterranean diet.

II. Determine the effects of controlled dietary interventions on metabolic parameters.

III. Determine the total number of potentially eligible patients who are approached by study coordinators and enter the equilibration period.

IV. Determine the effects of controlled dietary interventions on the fecal microbiome.

V. Create a well annotated bank of clinical data and samples, including but not limited to periprostatic fat, for use in future research and analysis.

VI. Examine the safety of controlled dietary interventions in patients with a diagnosis of prostate cancer.

VII. Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption.

VIII. Compare Cav-1-sphingolipid levels following dietary interventions in with a separate cohort of men who do not undergo pre-operative dietary intervention.

OUTLINE:

Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy.

After completion of study treatment, patients are followed up at 4-8 weeks.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (dietary intervention, radical prostatectomy)

Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy.

Group Type: EXPERIMENTAL

Dietary Intervention

Intervention Type: OTHER

Participate in Mediterranean diet

Radical Prostatectomy

Intervention Type: PROCEDURE

Undergo standard of care radical prostatectomy

Interventions

Dietary Intervention

Participate in Mediterranean diet

Intervention Type: OTHER

Radical Prostatectomy

Undergo standard of care radical prostatectomy

Intervention Type: PROCEDURE

Other Intervention Names

Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Prostatovesiculectomy

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justin R Gregg

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2021-02022

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-0673

Identifier Type: OTHER

Identifier Source: secondary_id

P50CA140388

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020-0673

Identifier Type: -

Identifier Source: org_study_id