This clinical trial is being done to evaluate whether following a controlled Mediterranean diet prior to prostate cancer surgery affects fasting insulin levels and other values that can be measured in blood and tissue samples taken at the time of surgery in patients with prostate cancer. Researchers also hope to better understand the impact of lifestyle changes in the setting of a prostate cancer diagnosis. Surgical removal of the prostate serves as one standard of care option for disease management. Despite this, many men will experience recurrence (disease returns) which may lead to more intensive medical therapies including androgen deprivation therapy which can lead to changes in the patient's health and metabolism including include insulin resistance. Lifestyle factors (e.g., diet) have emerged as a key player in the prevention, treatment, and outcomes of prostate cancer, with attention sharply focused on the Mediterranean diet for its safety and ability to slow disease progression. The diet will focus on including lean protein sources, high-quality fat and high-quality carbohydrate sources among others, and will limit refined sugars and high glycemic carbohydrates. Consuming a Mediterranean diet may be effective at slowing disease progression in patients undergoing surgery for prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06487507.
Locations matching your search criteria
United States
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer CenterStatus: Active
Contact: Nima Sharifi
Phone: 305-243-1350
PRIMARY OBJECTIVE:
I. Assess feasibility of a controlled, varying, Mediterranean diets in pre-surgical prostate cancer patients.
SECONDARY OBJECTIVES:
I. Assess preliminary efficacy of a controlled, varying, Mediterranean diets on fasting insulin and metabolic biomarkers.
II. Assess dietary behavior.
III. Assess the safety and tolerability of controlled, varying, Mediterranean diets.
EXPLORATORY OBJECTIVES:
I. Investigate changes in prostatic tissue and blood metabolomics.
II. Perform genotyping and genetic analyses.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients consume a prepared lower carbohydrate Mediterranean diet for 2 weeks on study then undergo standard of care radical prostatectomy. Patients also meet with a dietitian during baseline and prior to surgery, undergo blood sample collection during baseline and at time of surgery, and tissue collection at time of surgery.
ARM II: Patients consume a prepared low fat Mediterranean diet for 2 weeks on study then undergo standard of care radical prostatectomy. Patients also meet with a dietitian during baseline and prior to surgery, undergo blood sample collection during baseline and at time of surgery, and tissue collection at time of surgery.
After completion of study intervention, patients are followed up at 12 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorNima Sharifi
