Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: No
View:

• 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

Locations
United States
Texas
M D Anderson Cancer Center
Recruiting
Houston
Time Frame
Start Date: August 27, 2021
Estimated Completion Date: October 20, 2023
Participants
Target number of participants: 10
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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