Clinical trial NCT04985565: Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer
Official title: Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-02
Enrollment: 12
Sex: MALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease
timeFrame: Up to 1 year from site initiation
Secondary outcomes:
measure: Tolerance of Mediterranean diet
timeFrame: Up to 1 year
measure: The effects of controlled dietary interventions on metabolic parameters
timeFrame: Up to 1 year
measure: The effects of controlled dietary interventions on the fecal microbiome
timeFrame: Up to 1 year
measure: Create a well annotated bank of clinical data and samples, including peri-prostatic fat, for use in future research and analysis
timeFrame: Up to 1 year
measure: 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.
timeFrame: Up to 1 year
measure: Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption
timeFrame: Up to 1 year
measure: Determine changes in Cav-1-sphingolipid signature following dietary intervention compared to a separate cohort with no intervention
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Justin R Gregg
role: PRINCIPAL_INVESTIGATOR
References: