Impact of Mediterranean Diets on Prostate Cancer Metabolism
Elucidating the Metabolic Impact of Isocaloric, Controlled, Mediterranean-Type Diets in Treatment-Naïve Men With Prostate Cancer on Active Surveillance (DINE Study)
This study tests whether following a Mediterranean diet can help men with localized prostate cancer by looking at how it affects their metabolism and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05590624 on ClinicalTrials.gov |
What this trial studies
This study examines how Mediterranean-type diets affect the metabolism of men diagnosed with localized prostate cancer. It aims to evaluate the effects of these diets on non-malignant prostate tissue, host metabolism, systemic biomarkers, and the microbiome. Participants will be assigned to either a lower-carbohydrate or low-fat Mediterranean diet and their dietary behavior and compliance will also be assessed. The study seeks to provide insights into the optimal dietary approach for managing prostate cancer.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older with a high suspicion of prostate cancer who are eligible for active surveillance.
Not a fit: Patients with a prior diagnosis of prostate cancer or those currently following a Mediterranean, lower carbohydrate, ketogenic, vegan, or vegetarian diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify dietary interventions that improve metabolic health and outcomes for men with prostate cancer.
How similar studies have performed: While dietary interventions in cancer treatment are being explored, this specific approach focusing on Mediterranean diets in prostate cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males ≥18 years old * High suspicion of prostate cancer (PCa) per urologist's clinical evaluation * BMI \>18.5 * No prior PCa diagnosis or hormonal therapy (-ies) * Ability to read, write, speak, and understand English * Ability to provide informed consent * Candidate for and elects active surveillance (AS) if diagnostic biopsy is positive * Willingness to consume provided dietary interventions * Adequate organ and marrow function: White blood cell count (WBC) ≥2,500/mcL, Absolute neutrophil count (ANC) ≥1,500/mcL, Platelets ≥100,000/mcL, 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 Exclusion Criteria: * 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. * Previous intolerability to fiber-rich diets * Colitis, Irritable Bowel Syndrome, or other gastrointestinal condition per clinician discretion * Unwilling to undergo transperineal PCa biopsies * Food allergies or other major dietary restrictions * Receiving active medical treatment for Type I or Type II diabetes mellitus * Prior antibiotic usage (i.e. within last 30 days) at time of consent * Recent weight loss (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 * High risk as defined by PSA≥20 and/or PI-RADS 5 lesion as per clinician evaluation * History of diabetic ketoacidosis * Gout * Patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion * Recent (within last 30 days) device implant/joint requiring antibiotics as per clinician determination * Prior history of prostate biopsy infection * Uncontrolled hypertension as defined by blood pressure greater than 140/80 (with or without medication) * Gallbladder removed or plan to remove per clinician evaluation * Other malignancies actively receiving systemic treatment as per clinician evaluation
Where this trial is running
Cleveland, Ohio
- Case Comprehensive Cancer Center, Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Weight, MD — Center Director, Cleveland Clinic Urologic Oncology
- Study coordinator: Myra Krnac
- Email: krnacm@ccf.org
- Phone: 216-444-1047
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.