A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8,231
- 试验地点
- 1
- 主要终点
- Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)
研究概览
简要总结
This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 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
Placebo Arm
Eligible subjects will complete a 4-week placebo run-in followed by randomization to matched placebo in a 1:1 ratio.
干预措施: Placebo (Drug)
dustasteride arm
Eligible subjects will complete a 4-week placebo run-in followed by randomization to 0.5mg dutasteride in a 1:1 ratio. Randomization will be stratified by center.
干预措施: Dutasteride (Drug)
结局指标
主要结局
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)
时间窗: Years 1-2, Years 3-4, and Overall (Years 1-4)
Study biopsies (biop.) consisted of 10 biop. samples (cores) in a pre-defined pattern and were read at the central pathology laboratory. Biop. cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk sets at Years 1-2 and Years 3-4 included those with a positive biop. at Years 1-2 or a biop. after Months 18-24, and those with a positive biop. at Years 3-4 or a biop. after Month 42, respectively. Overall included participants with a positive biop. or biop. after Month 42.
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)
时间窗: Years 1-2, Years 3-4, and Overall (Years 1-4)
Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk set at Years 1-2, Years 3-4, and Overall (Years 1-4) were those who had a biopsy during the specified time period.
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)
时间窗: Years 1-2, Years 3-4, and Overall (Years 1-4)
Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia\[HGPIN\] or typical small acinar proliferation \[ASAP\]) and prostate surgeries were reviewed by the lead pathologist.
次要结局
- Percentage of Core Involved at Diagnosis(Baseline to Year 4)
- Treatment Alteration Score(Baseline to Year 4)
- Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment(Baseline to Year 4)
- Number of Participants With Post-biopsy Macroscopic Hematuria(Baseline to Year 4)
- Number of Participants With the Indicated Gleason Score at Diagnosis(Baseline to Year 4)
- Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy(Baseline to Year 4)
- Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48(Baseline, Month 24, and Month 48)
- Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms(Years 1-2, Overall (Years 1-4))
- Number of Participants With at Least One Event of Acute Urinary Retention (AUR)(Years 1-2 and Overall (Years 1-4))
- Number of Participants With Post-biopsy Macroscopic Hematospermia(Baseline through Year 4)
- Overall Survival(From time informed consent is signed to 4-month Safety Follow-Up period)
- Volume of HGPIN at Biopsy(Baseline to Year 4)
- Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48(Baseline and Months 12, 24, 36, and 48)
- Number of Participants With at Least One Urinary Tract Infection (UTI)(Years 1-2, Years 3-4, and Overall (Years 1-4))
- Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48(Baseline and Month 48)
- Number of Cancer-positive Cores(Baseline to Year 4)
- Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48(Baseline to Year 4 (Month 48))
- Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48(Baseline and Month 48)
- Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48(Baseline and Month 48)
- Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48(Baseline and Month 48)
- Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48(Month 48)
- Mean Change From Baseline in Testosterone at Month 48(Baseline and Month 48)
- Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48(Baseline and Month 48)