NCT04985565

Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the feasibility of a neoadjuvant feeding study prior to radical prostatectomy in a racially diverse group of men diagnosed with intermediate risk prostate cancer, defined as the percentage of patients who enter the pre-intervention equilibration period and begin the dietary intervention. SECONDARY OBJECTIVES: I. Determine the tolerance of Mediterranean diet as defined by compliance with diet of 70% or greater total calories consumed during study period from the Mediterranean diet. II. Determine the effects of controlled dietary interventions on metabolic parameters. III. Determine the total number of potentially eligible patients who are approached by study coordinators and enter the equilibration period. IV. Determine the effects of controlled dietary interventions on the fecal microbiome. V. Create a well annotated bank of clinical data and samples, including but not limited to periprostatic fat, for use in future research and analysis. VI. Examine the safety of controlled dietary interventions in patients with a diagnosis of prostate cancer. VII. Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption. VIII. Compare Cav-1-sphingolipid levels following dietary interventions in with a separate cohort of men who do not undergo pre-operative dietary intervention. OUTLINE: Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy. After completion of study treatment, patients are followed up at 4-8 weeks.

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

Interventions

Type	Name	Description
OTHER	Dietary Intervention	Participate in Mediterranean diet
PROCEDURE	Radical Prostatectomy	Undergo standard of care radical prostatectomy

Timeline

• Start date: 2021-08-27
• Primary completion: 2026-10-20
• Completion: 2026-10-20
• First posted: 2021-08-02
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States