NCT00363311已完成4 期
A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride in Extending the Time to Progression of Low-Risk, Localized Prostate Cancer in Men Who Are Candidates for or Undergoing Expectant Management
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression
研究概览
简要总结
The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dutasteride
Active Comparator
Dutasteride 0.5mg
干预措施: Dutasteride (Drug)
Placebo
Placebo Comparator
Matching placebo
干预措施: Matching placebo (Drug)
结局指标
主要结局
Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression
时间窗: Year 1.5 and Overall (Years 0-3)
PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: \>=4 cores involved; \>=50% of any 1 core involved; or a Gleason pattern of \>=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.
次要结局
- Number of Participants With Therapeutic Progression(Year 1.5 and Overall (Years 0-3))
- Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3(Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy))
- Mean Percentage of Cancer-positive Cores in a 12-core Biopsy(Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy))
- Number of Participants With Pathologic Progression(Year 1.5 and Overall (Years 0-3))
- Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis(Baseline to Month 18)
- Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy(Years 0-3)
- Number of Cancer-positive Cores in a 12-core Biopsy(Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy))
- Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3(Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy))
- Cumulative Length of Cancer Tumor Core(Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy))
- Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3(Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy))
- Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5(Year 1.5)
- Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3(Years 0-3 (Final Biopsy))
- Number of Participants With the Indicated Total Gleason Score(Years 0-3 (Final Biopsy))
- Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline(Baseline)
- Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage(Months 0-18)
- Prostate Volume (PV) LOCF(Baseline and Years 1.5 and 3)
- Change From Baseline in Prostate Volume at Years 1.5 and 3(Baseline and Years 1.5 and 3)
- Percent Change From Baseline in Prostate Volume at Years 1.5 and 3(Baseline and Years 1.5 and 3)
- Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)(Baseline and Month 3, 6, 12, 18, and 36)
- Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF(Baseline and Months 3, 6, 12, 18, and 36)
- Total MAX-PC Anxiety Subscale Score Related to PSA Testing(Baseline and Months 3, 6, 12, 18, and 36)
- Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)(Baseline and Months 3, 6, 12, 18, and 36)
- Total MAX-PC Fear of Recurrence Subscale Score(Baseline and Months 3, 6, 12, 18, and 36)
- Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)(Baseline and Months 3, 6, 12, 18, and 36)
- Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score(Baseline and Months 18 and 36)
- Change From Baseline in Total FACT-P Score (LOCF)(Baseline and Months 18 and 36)
- Percent Change From Baseline in Total FACT-P Score (LOCF)(Baseline and Months 18 and 36)
- Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)(Baseline and Months 18 and 36)
- Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)(Baseline and Months 18 and 36)
研究者
研究点 (1)
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