This clinical trial studies the metabolic impact of lower carbohydrate (LC) and low fat (LF) Mediterranean-type diets (Med-t-Diets) in men with prostate cancer who have not received treatment (treatment naïve) and are on active surveillance (AS). AS involves closely watching a patient's condition but not giving treatment unless there are changes in test results. Unfortunately, many men still experience disease progression on AS which results in a need for treatment with or without medical therapy (androgen deprivation therapy [ADT]). ADT may negatively impact patients' metabolism, which can pose a threat to their health. 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. This trial may help researchers understand the impact of LC and LF Med-t-Diets on patient metabolism after prostate cancer diagnosis and before beginning medical therapy.
Additional locations may be listed on ClinicalTrials.gov for NCT05590624.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Active
Contact: Christopher Weight
Phone: 216-444-1105
PRIMARY OBJECTIVE:
I. Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism as determined by changes in metabolomics from longitudinal prostate tissue specimens using mass spectrometry (MS).
SECONDARY OBJECTIVES:
I. Evaluate the impact of Med-t-Diets on host metabolism as determined by changes in metabolomics from longitudinal blood specimens using mass spectrometry (MS).
II. Evaluate the impact of Med-t-Diets on systemic biomarkers after consuming Med-t-Diets as determined by changes in hemoglobin A1C (HbA1C), C-reactive protein (CRP), lipid particle size and number, and insulin sensitivity (Homeostatic Model Assessment of Insulin Resistance [HOMA-IR score]) from longitudinal blood specimens collected in alignment with blood metabolomics specimen time points.
III. Evaluate the impact of Med-t-Diets on the microbiome and dietary behavior and compliance after consuming Med-t-Diets as determined by changes in alpha and beta diversity (16s ribonucleic acid [RNA] metagenomics) using longitudinal fecal specimens; behavioral changes using 24 hour dietary recalls and compliance by means of the metabolic kitchen team subtracting the weight of provided food not consumed as measured by ≥ 90 % of provided calories are consumed.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients consume the LF Med-t-Diet for 2 weeks, followed by a standard of care (SOC) biopsy. Patients who receive a diagnosis of prostate cancer and are candidates for AS then consume the LC Med-t-Diet for 2 weeks. Patients who receive a diagnosis of prostate cancer and are not candidates for AS enter follow-up. Patients also undergo collection of blood samples on study and collection of additional normal tissue during SOC biopsies.
ARM II: Patients consume the LC Med-t-Diet for 2 weeks, followed by a SOC biopsy. Patients who receive a diagnosis of prostate cancer and are candidates for AS then consume the LF Med-t-Diet for 2 weeks. Patients who receive a diagnosis of prostate cancer and are not candidates for AS enter follow-up. Patients also undergo collection of blood samples on study and collection of additional normal tissue during SOC biopsies.
After completion of the study intervention, patients are followed up at 3 months.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorChristopher Weight
