Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer (NCT04985565) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer
United States12 participantsStarted 2021-08-27
Plain-language 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.
Who can participate
Age range30 Years – 75 Years
SexMALE
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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 cr…
What they're measuring
1
Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease