Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer

NCT04985565 | Active Not Recruiting

• 3 other identifiers: 2020-0673NCI-2021-02022P50CA140388
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 year from site initiation

Secondary Outcomes (7)

• Tolerance of Mediterranean diet

  Up to 1 year

• The effects of controlled dietary interventions on metabolic parameters

  Up to 1 year

• The effects of controlled dietary interventions on the fecal microbiome

  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

  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.

  Up to 1 year

Study Arms (1)

Treatment (dietary intervention, radical prostatectomy)

EXPERIMENTAL

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

Other: Dietary Intervention; Procedure: Radical Prostatectomy

Interventions

Dietary Intervention OTHER

Participate in Mediterranean diet

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Treatment (dietary intervention, radical prostatectomy)

Radical Prostatectomy PROCEDURE

Undergo standard of care radical prostatectomy

Also known as: Prostatovesiculectomy

Treatment (dietary intervention, radical prostatectomy)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Justin R Gregg

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: August 2, 2021
• Study Start: August 27, 2021
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)