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.
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Participate in Mediterranean diet
Undergo standard of care radical prostatectomy
M D Anderson Cancer Center
Houston, Texas, United States
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.
Time frame: Up to 1 year from site initiation
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: 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
Anticipate 100% participation in patients who enroll and complete diet intervention.
Time frame: 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
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.
Time frame: Up to 1 year
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").
Time frame: Up to 1 year
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