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Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer

Primary Purpose

Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Radical Prostatectomy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (dietary intervention, radical prostatectomy)

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease
Feasibility is defined as >= 25% of patients who enter the equilibration period initiating the dietary intervention.

Secondary Outcome Measures

Tolerance of Mediterranean diet
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.
The effects of controlled dietary interventions on metabolic parameters
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.
The effects of controlled dietary interventions on the fecal microbiome
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.
Create a well annotated bank of clinical data and samples, including peri-prostatic fat, for use in future research and analysis
Anticipate 100% participation in patients who enroll and complete diet intervention.
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.
Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption
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
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").

Full Information

First Posted
March 24, 2021
Last Updated
September 1, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04985565
Brief Title
Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer
Official Title
Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
October 20, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (dietary intervention, radical prostatectomy)
Arm Type
Experimental
Arm Description
Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Participate in Mediterranean diet
Intervention Type
Procedure
Intervention Name(s)
Radical Prostatectomy
Other Intervention Name(s)
Prostatovesiculectomy
Intervention Description
Undergo standard of care radical prostatectomy
Primary Outcome Measure Information:
Title
Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease
Description
Feasibility is defined as >= 25% of patients who enter the equilibration period initiating the dietary intervention.
Time Frame
Up to 1 year from site initiation
Secondary Outcome Measure Information:
Title
Tolerance of Mediterranean diet
Description
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.
Time Frame
Up to 1 year
Title
The effects of controlled dietary interventions on metabolic parameters
Description
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.
Time Frame
Up to 1 year
Title
The effects of controlled dietary interventions on the fecal microbiome
Description
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.
Time Frame
Up to 1 year
Title
Create a well annotated bank of clinical data and samples, including peri-prostatic fat, for use in future research and analysis
Description
Anticipate 100% participation in patients who enroll and complete diet intervention.
Time Frame
Up to 1 year
Title
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
Title
Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption
Description
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.
Time Frame
Up to 1 year
Title
Determine changes in Cav-1-sphingolipid signature following dietary intervention compared to a separate cohort with no intervention
Description
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").
Time Frame
Up to 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin R Gregg
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer

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