Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer

September 17, 2026 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Procedure: Radical Prostatectomy
Undergo standard of care radical prostatectomy
Other Names:
  • Prostatovesiculectomy
Other: Dietary Intervention
Participate in Mediterranean diet
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease
Time Frame: Up to 1 year from site initiation
Feasibility is defined as >= 25% of patients who enter the equilibration period initiating the dietary intervention.
Up to 1 year from site initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tolerance of Mediterranean diet
Time Frame: Up to 1 year
Defined as compliance of 70% or greater total caloric intake consumed from the provided Mediterranean diet meals. Will estimate the number of patients that were compliant along with the 95% confidence intervals.
Up to 1 year
The effects of controlled dietary interventions on metabolic parameters
Time Frame: Up to 1 year
As measured using metabolomics (Cav-1-signature score) and nuclear magnetic resonance (NMR) spectroscopy (using Nightingale platform). Paired t-test will be used to compare the metabolic parameters changes (pre- and post- dietary intervention) in untargeted mass spectrometry-based metabolite levels and NMR-based metabolite levels.
Up to 1 year
The effects of controlled dietary interventions on the fecal microbiome
Time Frame: Up to 1 year
Exploratory analysis using microbiome core. Fecal microbiome samples will be summarized using alpha diversity, computed using the inverse Simpson index, which can then be compared across time points using a paired t-test.
Up to 1 year
Create a well annotated bank of clinical data and samples, including peri-prostatic fat, for use in future research and analysis
Time Frame: Up to 1 year
Anticipate 100% participation in patients who enroll and complete diet intervention.
Up to 1 year
Examine the safety of controlled dietary interventions in patients with a diagnosis of prostate cancer percentage of severe adverse reactions in patients completing the diet.
Time Frame: Up to 1 year
Up to 1 year
Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption
Time Frame: Up to 1 year
Will compare the baseline Cav-1-signature score levels with the post-diet (day of surgery) levels using paired t-tests. This evaluation is exploratory in nature and will be used to guide power calculations for future studies.
Up to 1 year
Determine changes in Cav-1-sphingolipid signature following dietary intervention compared to a separate cohort with no intervention
Time Frame: Up to 1 year
Will use a two-sample t-test to compare the levels of Cav-1-sphingolipid signature score in men who undergo a dietary intervention in this protocol with subjects enrolled under the separate protocol (protocol 2020-0828, "Diet, Biomarker, and Tissue Assessment in Intermediate Risk Prostate Cancer").
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Justin R Gregg, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-0673 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-02022 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • P50CA140388 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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