NCT04985565Active, not recruiting
Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 24 Mar 2021
- Start date
- 27 Aug 2021
- Primary completion date
- 20 Oct 2026
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT04985565
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 27 Aug 2021 to the primary completion date, 20 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current self-reported smoker or heavy drinker (defined as \>14 drinks per week) or current self-reported illicit drug use
Other illness
- Major dietary restrictions or food allergies
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 30 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.