NCT01433913已完成2 期
Phase II Study of Metformin in a Pre-prostatectomy Prostate Cancer Cohort
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Cell Proliferation in the Prostatectomy Tissue as Assessed by Ki67 Expression Using Immunohistochemistry (IHC)
研究概览
简要总结
This randomized phase II trial studies how well metformin hydrochloride works compared to placebo in treating patients with prostate cancer undergoing surgery. Metformin hydrochloride may make some enzymes active. These enzymes may block other enzymes needed for cell growth and stop the growth of tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To determine the effect of 4-12 weeks of metformin (metformin hydrochloride) intervention on cell proliferation in the prostatectomy tissue.
SECONDARY OBJECTIVES:
I. To determine the effect of metformin intervention on prostate tissue bioavailability of metformin.
II. To determine the effect of metformin intervention on apoptosis and angiogenesis in the prostatectomy tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Men will be eligible to this study if they are diagnosed with a histologically confirmed organ-confined adenocarcinoma of the prostate (PCa) treatable by prostatectomy and have a current PSA less than 50 ng/ml
- •Have not received chemotherapy and/or radiation for any malignancy (excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment) in the past 5 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky >= 70%)
- •Leukocytes >= 3,000/uL
- •Absolute neutrophil count >= 1,500/uL
- •Platelets >= 100,000/uL
- •Total bilirubin =< 1.5 times institutional upper limits of normal (ULN)
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 times institutional ULN
- •Creatinine within normal institutional limits
- •Willing to use adequate contraception (barrier method, abstinence, subject has had a vasectomy or partner is using effective birth control or is postmenopausal) for the duration of study participation
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Type I or type II diabetic patients on treatment with any drug for diabetes or participants with fasting glucose >= 126 mg/dL
- •History of impaired liver or kidney function
- •Participants with a current history of high alcohol consumption (> 3 standard drinks/day) or binge drinking (5 or more drinks) in one session of 1-3 hours
- •History of lactic acidosis or at increased risk for lactic acidosis such as patients with unstable or acute congestive heart failure who are at risk of hypoperfusion with hypoxemia
- •Participants may not be receiving any other investigational agents
- •History of allergic reactions attributed to compounds of similar chemical composition to metformin
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •History of acute or chronic metabolic acidosis
- •Concurrent use of cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin)
- •Concurrent use of non-study metformin or other biguanides
研究组 & 干预措施
Arm I (metformin hydrochloride)
Experimental
Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.
干预措施: metformin hydrochloride (Drug)
Arm I (metformin hydrochloride)
Experimental
Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.
干预措施: laboratory biomarker analysis (Other)
Arm II (placebo)
Placebo Comparator
Patients receive placebo PO QD for 4-12 weeks.
干预措施: placebo (Other)
Arm II (placebo)
Placebo Comparator
Patients receive placebo PO QD for 4-12 weeks.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Cell Proliferation in the Prostatectomy Tissue as Assessed by Ki67 Expression Using Immunohistochemistry (IHC)
时间窗: 12 weeks
Data between the two study groups will be compared using a two-group t-test at a two-sided 0.05 level of significance. If the data are not normally distributed, a non-parametric rank-sum test will be utilized.
次要结局
- AMPK Activation in the Prostatectomy Tissue as Assessed by IHC of p-AMPK(12 weeks)
- Cell Cycle Regulation in the Prostatectomy Tissue as Assessed by IHC of Retinoblastoma Protein Phosphorylation (p-pRb)(12 weeks)
- Changes in Serum Fasting Insulin(Baseline and 12 weeks)
- Prostate Tissue Metformin Concentration Levels as Assessed by Liquid Chromatography Tandem Mass Spectrometry(12 weeks)
- Cell Cycle Regulation in the Prostatectomy Tissue as Assessed by IHC of Cyclin D1(12 weeks)
- Changes in Serum PSA(Baseline and 12 weeks)
- Angiogenesis in the Prostatectomy Tissue as Assessed by IHC of CD34(12 weeks)
- Apoptosis Levels in the Prostatectomy Tissue as Assessed by IHC of Cleaved Caspase 3(12 weeks)
- Changes in Serum Testosterone(Baseline and 12 weeks)
- Changes in Serum SHBG(Baseline and 12 weeks)
- Changes in Serum Fasting Glucose(Baseline and 12 weeks)
- mTOR Regulation in the Prostatectomy Tissue as Assessed by IHC of Phospho-p70 S6 Kinase (p-p70S6K)(12 weeks)
- Changes in Serum IGF-1/IGFBP-3(Baseline and 12 weeks)
研究者
研究点 (3)
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