A Randomized Placebo-Controlled Double-Blind Clinical Trial to Assess the Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume.
研究概览
简要总结
The purpose of this study is to determine the effect of short-term intake of daily Dutasteride in patients with prostate cancer.
详细描述
This is a study of men who have undergone a standard 10 or more core biopsy for detection of prostate cancer and determined to have prostate cancer by having a Gleason score ≤ 7 (low to moderate risk 2-7). Of these men, one arm of a two arm randomized group will be administered a treatment regime of Dutasteride versus the control group who receive standard of care, prior to mapping biopsy. This proposal aims at studying the apparent effect of the use of Dutasteride (3 months) on initial tumor volume (at diagnosis) in men with low volume cancer before undergoing 3D mapping biopsy.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •40-85 year old males
- •Patient is newly diagnosed with clinical Stage T1a-T2c prostate cancer based on transrectal guided extended prostate biopsy of at least 10 cores.
- •Patient elects to undergo 3D mapping biopsy at our center as part of prostate cancer management.
- •Patient will read, understand and sign the informed consent agreement
- •Patients must have a life expectancy of at least one year.
- •Gleason score ≤ 7 (low to moderate risk 2-7) 7= 3+4
- •Percentage positive core rate < 50% based on sextant or extended biopsy technique.
- •Prostate Volume (PV) >15 grams.
- •Negative imaging studies ( if available) during the staging period such as Bone scan, MRI and CT scan if PSA> 10 ng.dl before initiation of the study drug
排除标准
- •Any 5α-reductase inhibitors medications within the past 12 months before enrollment.
- •Known hypersensitivity to dutasteride, or other 5α-reductase inhibitors.
- •Anticipated blood donation within the next 90 days.
- •Serum PSA levels of >20ng/dl.
- •Clinical evidence of metastatic prostate cancer.
- •Two documented urinary tract infections in the past year
- •CHF, MI (within 6 months) or other symptomatic CVS disease
- •Other serious diseases (hematological, hepatic, renal, respiratory or psychiatric)
- •Enrollment in other studies for any disease in the past 30 days
- •Significant urinary incontinence
- •Diagnosis of cancer that in not considered cured, except BCC of skin
- •Prior transurethral resection of the prostate with a large tissue defect.
- •History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology
- •Previous or concurrent radiotherapy, hormonal therapy or chemotherapy
研究组 & 干预措施
Dutasteride
The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months.
干预措施: Dutasteride (Drug)
Placebo
The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.
干预措施: Placebo (Other)
结局指标
主要结局
To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume.
时间窗: 24 Months
The effect of Dutasteride intake on the following parameters as detected by mapping biopsy vs. initial trans-rectal biopsy in the treatment arm and the control group: change in prostate gland volume, change in distribution within the gland, and change in Gleason score sum.
次要结局
未报告次要终点