|Title||Metformin Prostate Cancer Adjuvant Trial|
|Description||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 and who have indicators of high-risk disease will be administered Metformin (750mg 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. The purpose of this study is to investigate whether Metformin can prolong or increase Prostate Specific Antigen (PSA) doubling time. PSA is a protein produced by the cells of the prostate gland. Current research has shown that the PSA doubling time is an important marker of disease progression and survival in men with prostate cancer where faster doubling times are associated with negative disease outcomes.
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 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. There are risks associated with this study, including the risk of medication side effects (such as hypoglycemia, diarrhea, nausea and vomiting), minor risks associated with blood draws, including fainting/lightheadedness, hematoma, or a small risk of infection. There is also a risk that the study will not prolong PSA doubling time or prevent disease progression.
|Inclusion/Notes||Prostate cancer patients who have received treatment with radiation therapy or surgery AND who have indicators of high-risk disease.|