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Metformin Prostate Cancer Adjuvant Trial Summary

Eligibility: Prostate cancer patients who have received treatment with radiation therapy or surgery AND who have indicators of high-risk disease.
 
This study is a clinical trial to determine if Metformin can improve quality of life and disease outcomes in patients with prostate cancer who have failed primary therapy.  Prostate cancer patients who have received treatment with radiation therapy or surgery, who have indicators of high-risk disease will be administered 750mg Metformin Extended Release twice per day for a period of 9 months.  Metformin is an FDA-approved drug that is prescribed to treat high blood sugar levels in patients with Type 2 Diabetes.  There are very few side effects, which include hypoglycemia (10% of diabetic patients), diarrhea (9.6% of diabetic patients), nausea and vomiting (6.5% of diabetic patients) and constipation (Between 1-5% of diabetic patients).  In a clinical trial of Metformin given to metastatic prostate cancer patients, there were side effects including weight loss (14% of patients), and fatigue (18% of patients), but this was not a placebo controlled trial and therefore the side effects may not be directly caused by the medication.
 
As part of this clinical trial, study participants will have their blood sugar levels monitored by obtaining Hemoglobin A1C and insulin levels via a blood test.  Hemoglobin A1C is a blood marker that is used to determine blood sugar levels over a long period of time.  To track prostate cancer response in study participants, investigators will obtain prostate specific antigen (PSA) levels every three months for the duration of the trial.  Study participants will also be observed for any adverse effects of the study medication, and any evidence of prostate cancer progression.
 
The investigators have determined that this study presents no more than minimal risk to the study participants.   Recently, there have been several clinical trials where Metformin has been administered to patients with various types of cancers, including prostate cancer, colon cancer, and breast cancer.  In each of these studies, the use of this drug has been determined to be safe.  Therefore, this study presents no more than minimal risk to study participants.

For more information please contact our research coordinator at 516-535-1900 or UrologyResearch@nyuwinthrop.org

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