The overall goal of this study is to identify a safe dose of metformin, in combination with oligomeric procyanidin complex (OPC) for pharmacologic reduction of AGE levels in patients with prostate cancer.
AGEs (advanced glycation endpoints) are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to identify safe pharmaceutical agents that can reduce the AGE levels in subjects with advanced cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Metformin: The starting dose for Metformin is 850mg once a day, the second dose is 850mg once a day; the third dose level is 850mg twice a day; the fourth dose level is 850mg twice a day. Each dose level lasts for 28 days.
OPC: The starting dose for OPC is 500mg once a day; the second dose is 1000mg once a day; the third dose level is 1000mg once a day; the fourth dose level is 1500mg once a day. Each dose level lasts for 28 days.
Medical University of South Carolina
Charleston, South Carolina, United States
Maximum tolerated dose (MTD) of metformin in combination with OPC in PCa subjects.
Time frame: 112 days
Correlation between changes to AGE level and changes to PSA.
Time frame: 112 days
Correlation between changes to AGE level and changes to BMI.
Time frame: 112 days
Correlation between changes to AGE level and changes to insulin resistance.
Time frame: 112 days
Correlation between changes to AGE level and changes to A1C.
Time frame: 112 days
Correlations between changes to AGE level and changes to testosterone.
Time frame: 112 days
Correlation between changes to AGE level and changes to diet.
Time frame: 112 days
Correlation between changes to AGE level and changes to quality of life.
FACT-P and AUA questionnaires
Time frame: 112 days
Frequency of adverse events as assessed by CTCAE v. 4
Toxicities will be tabulated by type and grade and the proportion of patients with grade 3, grade 4 or an SAE will be estimated with a 90% confidence interval.
Time frame: 112 days
Correlation between AGE levels and sRAGE (soluble receptor for AGE) expression and signaling.
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Time frame: 112 days
Correlation between changes to AGE level and OPC metabolite levels.
Time frame: 112 days
Correlation between changes to AGE level and changes in the stool. microbiome.
Time frame: 112 days