NCT01864096进行中（未招募）3 期
A Randomized, Double-Blind, Placebo-Controlled Trial of Metformin in Reducing Progression Among Men on Expectant Management for Low Risk Prostate Cancer: The MAST (Metformin Active Surveillance Trial) Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 408
- 试验地点
- 12
- 主要终点
- Time to progression
研究概览
简要总结
This study aims to see if metformin can delay the time to progression in men with low risk prostate cancer when compared to a placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Must be male > 18 and < 80 years of age
- •Have biopsy proven, low-risk, localized prostate cancer choosing expectant management as primary treatment ≤ 1year. [For the purposes of assessing subject eligibility a diagnostic biopsy must have included at least 10 cores, ≤1/3 of total number of cores sampled and < 50% of any one core positive) and must have been obtained within 6 months of screening]. Initial diagnosis of T1a/T1b obtained during a TURP is not allowed
- •Gleason score ≤ 6 [Gleason pattern 4 or above must not be present on any biopsy (initial or entry)]
- •Clinical stage T1c-T2a
- •Serum PSA ≤10 ng/mL (prior to biopsy)
- •Life expectancy greater than 5 years, as judged by the treating clinician/urologist
- •Able to swallow and retain oral medication
- •Hemoglobin A1c < 6.5%
- •Able and willing to participate in the full 3 years of the study
- •Able to understand instructions related to study procedures
- •Able to read and write (health outcome questionnaires are self-administered), understand instructions related to study procedures and give written informed consent
排除标准
- •Subject that has ever been treated for prostate cancer with any of the following:
- •Radiotherapy (external beam or brachytherapy)
- •Chemotherapy
- •Hormonal therapy (e.g., megestrol, medoxyprogesterone, cyproterone)
- •Oral glucocorticoids
- •GnRH analogues (e.g., leuprolide, goserelin, degarelix)
- •Current and/or previous use of the following medications:
- •Use of 5α-reductase inhibitors (eg. Finasteride, Dutasteride) within the past 6 months of screening
- •Drugs with antiandrogenic properties (e.g., flutamide, bicalutamide, ketoconazole, progestational agents) within 6 months prior to screening
- •Previous or current diagnosis of type 1 or type 2 diabetes
- •Exposure to metformin within 12 months of screening
- •Planned or concurrent use of metformin hydrochloride, sulfonylureas, thiazolidinediones, or insulin for any reason
- •Known hypersensitivity or intolerance to metformin hydrochloride
- •Any condition associated with increased risk of metformin hydrochloride-associated lactic acidosis (e.g. congestive heart failure defines as NYHA class III or IV, history of any type of acidosis, habitual intake of ≥ 4 alcoholic beverages per day)
- •Subject has had prior prostatic surgery including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of screening
- •Participation in any investigational or marketed drug trial within 30 days prior to screening or anytime during the study period. This includes any interventional or exercise trials
- •Any unstable serious co-existing medical condition(s) 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 visit
- •Abnormal liver function test:
- •Total bilirubin > 1.8 X institutional upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) > 1.8 X institutional ULN
- •Alanine aminotransferase (ALT) > 1.8 X institutional ULN
- •Alkaline phosphatase (ALP) > 1.8 X institutional ULN
- •Serum creatinine > 1.8 X ULN
- •History of other malignancies, with the exception of adequately treated nonmelanoma skin cancer, stage I melanoma, NMIBC or other solid tumors curatively treated with no evidence of disease for at least 5 years
- •History or current evidence of substance abuse, as defined in DSM-IV, 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 pose additional risk to the subject
- •No other concurrent metformin hydrochloride, sulfonylureas, thiazolidinediones, or insulin for any reason
研究组 & 干预措施
Metformin
Experimental
Metformin 850 mg, twice daily for 36 months
干预措施: Metformin (Drug)
Placebo
Placebo Comparator
Placebo tablets, 2teice daily for 36 months
干预措施: Placebo (Drug)
结局指标
主要结局
Time to progression
时间窗: 3 years
Time to progression - progression is defined as the earliest of the following events: 1. Primary therapy for prostate cancer (e.g. prostatectomy, radiation, hormonal therapy) 2. Pathological progression as defined as one of the following: i. \>1/3 of total amount of cores involved ii. At least 50% of any one core involved iii. Gleason pattern 4 or higher
次要结局
- Change from baseline in prostate cancer diagnosis at repeat biopsy(3 years)
- Change from baseline in disease-related patient anxiety(3 years)
- Assess the prognostic and predictive value of prostate cancer biomarkers(3 years)
- Time to pathological progression(3 years)
- To determine the safety and incidence of (serious) adverse events from the administration of 36 months of metformin to men with early stage prostate cancer(3 years)
- Time to primary therapy for prostate cancer(3 years)
- Change from baseline in decisional satisfaction and decisional conflict(3 years)
- Change in Gleason Score at repeat biopsy(3 years)
- Change in clinical stage of prostate cancer based on digital rectal examination(3 years)
研究者
研究点 (12)
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