RECRUITING

Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study aims to investigate whether following a controlled Mediterranean-style diet prior to robotic-assisted radical prostatectomy surgery in patients diagnosed with prostate cancer affects fasting insulin levels and other values that can be measured in blood and tissue samples from surgery.

Official Title

Metabolic Impact and Compliance of Controlled, Varying, Mediterranean Diets in Pre-Surgical Prostate Cancer Populations (PROVISIONS)

Quick Facts

Study Start:2025-04-17

Study Completion:2026-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06487507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Males 18 to 80 years old scheduled to undergo radical prostatectomy as per standard of care. * BMI between 18.5 and 40 * Ability to read, write, speak, and understand English and/or Spanish. * Ability to provide informed consent. * Willingness to consume provided dietary interventions. * Adequate organ and marrow function as assessed by treating clinician(s) which includes: White blood cell count (WBC) ≥2,500/microliter. Absolute neutrophil count (ANC) ≥1,500/microliter. Platelets ≥100,000/microliter. Hemoglobin ≥9 g/dL (transfusions permitted) Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For subjects with Gilbert's disease ≤3.0 mg/dL. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤2.5 x institutional ULN. Creatinine clearance ≥51 ml/min as defined by Cockcroft-Gault equation.	* Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber \> per 1,000 Calories) and/or any supplements (including herbal), vitamins, minerals, that would interfere with diets being tested in the study as determined by dietitian and/or investigators as these diets are highly restrictive and may impact objectives/outcomes in the trial. * Previous intolerability to fiber-rich diets. * Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion. * Food allergies or other major dietary restrictions. * Receiving active medical treatment for Type I or Type II diabetes mellitus. * Recent weight loss or gain (both intentional and unintentional) as defined by 5%+ body weight in the last 30 days. * Undergone any type of weight loss surgery. * Any medical contraindications as determined by investigators. * History of diabetic ketoacidosis. * History of Gout. * Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion. * Gallbladder removed or plan to remove per clinician evaluation. * Other malignancies actively receiving systemic treatment as per clinician evaluation. * Previous treatment for prostate cancer. * Previous history of pelvic radiation. * Patients with impaired decision-making capacity.

Inclusion Criteria

Exclusion Criteria

* Males 18 to 80 years old scheduled to undergo radical prostatectomy as per standard of care.
* BMI between 18.5 and 40
* Ability to read, write, speak, and understand English and/or Spanish.
* Ability to provide informed consent.
* Willingness to consume provided dietary interventions.
* Adequate organ and marrow function as assessed by treating clinician(s) which includes: White blood cell count (WBC) ≥2,500/microliter. Absolute neutrophil count (ANC) ≥1,500/microliter. Platelets ≥100,000/microliter. Hemoglobin ≥9 g/dL (transfusions permitted) Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For subjects with Gilbert's disease ≤3.0 mg/dL. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤2.5 x institutional ULN. Creatinine clearance ≥51 ml/min as defined by Cockcroft-Gault equation.

* Currently consuming a Mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber \> per 1,000 Calories) and/or any supplements (including herbal), vitamins, minerals, that would interfere with diets being tested in the study as determined by dietitian and/or investigators as these diets are highly restrictive and may impact objectives/outcomes in the trial.
* Previous intolerability to fiber-rich diets.
* Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion.
* Food allergies or other major dietary restrictions.
* Receiving active medical treatment for Type I or Type II diabetes mellitus.
* Recent weight loss or gain (both intentional and unintentional) as defined by 5%+ body weight in the last 30 days.
* Undergone any type of weight loss surgery.
* Any medical contraindications as determined by investigators.
* History of diabetic ketoacidosis.
* History of Gout.
* Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion.
* Gallbladder removed or plan to remove per clinician evaluation.
* Other malignancies actively receiving systemic treatment as per clinician evaluation.
* Previous treatment for prostate cancer.
* Previous history of pelvic radiation.
* Patients with impaired decision-making capacity.

Contacts and Locations

Study Contact

Nima Sharifi, MD

CONTACT

305-243-1350

nimasharifi@miami.edu

Elena Cortizas, MS

CONTACT

3052433593

ecortizas@med.miami.edu

Principal Investigator

Nima Sharifi, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Nima Sharifi, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-17

Study Completion Date2026-05-01

Study Record Updates

Study Start Date2025-04-17

Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer