度他雄胺联合坦索罗辛治疗下尿路症状和前列腺增大患者对前列腺活检率和前列腺癌诊断的影响：Combination of Avodart and Tamsulosin 试验。
Effect of dutasteride on prostate biopsy rates and the diagnosis of prostate cancer in men with lower urinary tract symptoms and enlarged prostates in the Combination of Avodart and Tamsulosin trial.
机构信息
Department of Urology, UT Southwestern Medical Center, Dallas, TX, USA.
出版信息
Eur Urol. 2011 Feb;59(2):244-9. doi: 10.1016/j.eururo.2010.10.040. Epub 2010 Nov 4.
BACKGROUND
A 23% relative risk reduction (RRR) in prostate cancer (PCa) was shown in men receiving dutasteride in the 4-yr Reduction by Dutasteride of Prostate Cancer Events study, in whom biopsies were protocol dependent.
OBJECTIVE
Our aim was to explore PCa risk reduction in men with benign prostatic hyperplasia (BPH) from the Combination of Avodart and Tamsulosin (CombAT) study, in which biopsies were undertaken for cause.
DESIGN, SETTING, AND PARTICIPANTS: CombAT was a 4-yr randomized double-blind parallel group study in 4844 men ≥50 yr of age with clinically diagnosed moderate to severe BPH, International Prostate Symptom Score ≥12, prostate volume ≥30 ml, and serum prostate-specific antigen (PSA) 1.5-10 ng/ml. Men underwent annual PSA measurement and digital rectal examination (DRE), and prostate biopsies were performed for cause.
INTERVENTION
All patients took tamsulosin 0.4 mg/d, dutasteride 0.5 mg/d, or a combination of both.
MEASUREMENTS
The primary end point was incidence of PCa. Secondary end points included postbaseline prostate biopsy rates and Gleason score of cancers.
RESULTS AND LIMITATIONS
Dutasteride (alone or in combination with tamsulosin) was associated with a 40% RRR of PCa diagnosis compared with tamsulosin monotherapy (95% confidence interval, 16-57%; p=0.002) and a 40% reduction in the likelihood of biopsy. There were similar reductions in low- and high-grade Gleason score cancers. The biopsy rate in the groups receiving dutasteride trended toward a higher diagnostic yield (combination: 29%, dutasteride: 28%, tamsulosin: 24%). One limitation was the lack of a standardized approach to PCa diagnosis and grading.
CONCLUSIONS
Dutasteride, alone or in combination with tamsulosin, significantly reduced the relative risk of PCa diagnosis in men with BPH undergoing annual DRE and PSA screening. Consistent with the increased usefulness of PSA for PCa detection, men receiving dutasteride had a numerically lower biopsy rate and higher yield of PCa on biopsy.
TRIAL REGISTRATION
Clinicaltrials.gov identifier: NCT00090103 (http://www.clinicaltrials.gov/ct2/show/NCT00090103).
背景
在接受度他雄胺治疗的男性中，前列腺癌（PCa）的相对风险降低了 23%（RRR），这在接受度他雄胺 4 年降低前列腺癌事件研究的男性中得到了证实，在这些男性中，活检是基于协议进行的。
目的
我们的目的是探讨 CombAT 研究中患有良性前列腺增生（BPH）的男性的 PCa 风险降低情况，在该研究中，由于前列腺特异性抗原（PSA）水平升高、直肠指检异常或其他指征而进行了前列腺活检。
设计、设置和参与者：CombAT 是一项 4 年随机双盲平行组研究，纳入 4844 名年龄≥50 岁、临床诊断为中重度 BPH、国际前列腺症状评分≥12、前列腺体积≥30ml、血清 PSA 1.5-10ng/ml 的男性。所有患者均接受坦索罗辛 0.4mg/d、度他雄胺 0.5mg/d 或两者联合治疗。
干预措施
所有患者均接受坦索罗辛 0.4mg/d、度他雄胺 0.5mg/d 或两者联合治疗。
测量指标
主要终点是 PCa 的发生率。次要终点包括基线后前列腺活检率和癌症的 Gleason 评分。
结果和局限性
与坦索罗辛单药治疗相比，度他雄胺（单独或联合坦索罗辛）使 PCa 诊断的相对风险降低了 40%（95%置信区间，16-57%；p=0.002），并且活检的可能性降低了 40%。低级别和高级别 Gleason 评分的癌症也有类似的降低。接受度他雄胺治疗的两组活检率呈上升趋势，诊断率更高（联合组：29%，度他雄胺组：28%，坦索罗辛组：24%）。一个局限性是缺乏标准化的 PCa 诊断和分级方法。
结论
度他雄胺单独或联合坦索罗辛可显著降低接受年度直肠指检和 PSA 筛查的 BPH 男性 PCa 诊断的相对风险。与 PSA 对 PCa 检测的更有用性一致，接受度他雄胺治疗的男性活检率较低，活检时 PCa 的检出率更高。
试验注册
Clinicaltrials.gov 标识符：NCT00090103（http://www.clinicaltrials.gov/ct2/show/NCT00090103）。
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