Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer

Not Applicable

Active, not recruiting

• 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
• Interventions: Other: Dietary Intervention; Procedure: Radical Prostatectomy

• Registration Number: NCT04985565
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-02
• Study Start: 2021-08-27
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-10-20
• Study Completion: 2025-10-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (dietary intervention, radical prostatectomy)	Radical Prostatectomy	Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy.
Treatment (dietary intervention, radical prostatectomy)	Dietary Intervention	Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy.

Primary Outcome Measures

Name	Time	Method
Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease	Up to 1 year from site initiation	Feasibility is defined as \>= 25% of patients who enter the equilibration period initiating the dietary intervention.

Secondary Outcome Measures

Name	Time	Method
The effects of controlled dietary interventions on the fecal microbiome	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.
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.	Up to 1 year
Tolerance of Mediterranean diet	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.
Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption	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.
Determine changes in Cav-1-sphingolipid signature following dietary intervention compared to a separate cohort with no intervention	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").
Create a well annotated bank of clinical data and samples, including peri-prostatic fat, for use in future research and analysis	Up to 1 year	Anticipate 100% participation in patients who enroll and complete diet intervention.
The effects of controlled dietary interventions on metabolic parameters	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States