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Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04985565
Recruitment Status : Active, not recruiting
First Posted : August 2, 2021
Last Update Posted : September 6, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Other: Dietary Intervention Procedure: Radical Prostatectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer
Actual Study Start Date : August 27, 2021
Estimated Primary Completion Date : October 20, 2023
Estimated Study Completion Date : October 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Dietary Intervention
Participate in Mediterranean diet
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

Procedure: Radical Prostatectomy
Undergo standard of care radical prostatectomy
Other Name: Prostatovesiculectomy


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 ]
  6. 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.

  7. 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").


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04985565


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Justin R Gregg M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04985565    
Other Study ID Numbers: 2020-0673
NCI-2021-02022 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0673 ( Other Identifier: M D Anderson Cancer Center )
P50CA140388 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases