Clinical trial · Interventional
Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer
NCT04985565CI-TRIAL-00107723active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IIA Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary Intervention | Other | — | UNRESOLVED |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (dietary intervention, radical prostatectomy)
- description
- Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy.
- interventionNames
- Other: Dietary Intervention
- Procedure: Radical Prostatectomy
Primary outcomes (1)
- measure
- Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease
- timeFrame
- Up to 1 year from site initiation
- description
- Feasibility is defined as \>= 25% of patients who enter the equilibration period initiating the dietary intervention.
Secondary outcomes (7)
- measure
- Tolerance of Mediterranean diet
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 criteria (as follows): * pT3a or higher disease * Grade group 4 or 5 adenocarcinoma of prostate * PSA \> 20ng/mL
References
Publications (0)
Data not yet available
No reference posted for this study.