Phase II Clinical Study of Effect of Metformin on Prostate Specific Antigen Doubling Time
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Mean Prostate Specific Antigen (PSA) Level
研究概览
简要总结
This is a Phase II clinical study to determine if Metformin can increase Prostate Specific Antigen (PSA) doubling time for patients with Prostate Cancer who have failed primary treatment with radiation, or surgical patients that are at high risk for recurrence based on surgical pathology. Men with confirmed prostate cancer and rising serum PSA levels will receive Metformin and will be monitored for PSA response and disease progression.
详细描述
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. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male > 18 years of age
- •Biopsy confirmed adenocarcinoma of the prostate
- •Able to swallow and retain oral medication
- •Hemoglobin A1C <7.0%
- •Able and willing to participate in the full 12 months of the study
- •Able to understand instructions related to study procedures
- •Able to read and write English
排除标准
- •Metastatic Prostate Cancer
- •Prostate Specific Antigen Doubling Time < 6 months
- •Prior Chemotherapy, hormonal therapy, oral glucocorticoid therapy, Gonadotropin-releasing hormone analogue therapy
- •Current or previous use of 5α-reductase inhibitors, antiandrogen drugs, metformin, oral or injectable diabetes drug
- •Diagnosis of Type 1 Diabetes Mellitus
- •Known hypersensitivity to metformin
- •any condition associated with increased risk of metformin associated lactic acidosis
- •participation in any investigational or marketed drug trial within 30 days prior to screening or during study period
- •any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening
- •history of megaloblastic anemia
- •abnormal liver function test (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or serum creatinine above upper limit of normal)
- •history of other malignancies, with the exception of adequately treated non-melanoma skin cancer, stage 1 melanoma, non-muscle invasive bladder cancer, or other solid tumors curatively treated with no evidence of disease for at least 5 years
- •history or current evidence of substance abuse within 12 months of screening
- •history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or post an additional risk to the subject
研究组 & 干预措施
Surgery - High Risk, Undetectable prostate-specific antigen (PSA)
干预措施: Metformin Hydrochloride Extended Release 750mg (Drug)
Radiation - Rising PSA
干预措施: Metformin Hydrochloride Extended Release 750mg (Drug)
Surgery - Rising PSA
干预措施: Metformin Hydrochloride Extended Release 750mg (Drug)
结局指标
主要结局
Mean Prostate Specific Antigen (PSA) Level
时间窗: 9 months
次要结局
未报告次要终点