Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer

Launched by CASE COMPREHENSIVE CANCER CENTER · Oct 19, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how different Mediterranean-style diets affect the metabolism of men with localized prostate cancer. Researchers want to understand if these diets, which are often low in carbohydrates and fats, can benefit men who are suspected to have prostate cancer. The study is currently looking for male participants aged 18 and older who have a high suspicion of prostate cancer but have not yet been diagnosed or treated. Participants should have a body mass index (BMI) above 18.5 and must be able to follow the dietary guidelines provided during the study.

If you decide to join this trial, you will be asked to follow a specific diet, and you'll be monitored to see how your body responds. To be eligible, you should not be on certain restrictive diets or have specific medical conditions that might interfere with the study. It’s important that participants can understand English and give their consent to join. This study aims to provide new insights into dietary choices that could potentially improve health outcomes for men facing prostate cancer.

Gender

MALE

Eligibility 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