Wilt T J, Brawer M K
Department of Medicine, Minneapolis VA Medical Center, Minnesota, USA.
Oncology (Williston Park). 1997 Aug;11(8):1133-9; discussion 1139-40, 1143.
The Prostate Cancer Intervention Versus Observation Trial (PIVOT) is a randomized trial designed to determine whether radical prostatectomy or expectant management provides superior length and quality of life for men with clinically localized prostate cancer. Conducted at Department of Veterans Affairs and National Cancer Institute medical centers, PIVOT will enroll over 1,000 individuals < 75 years of age. The primary study end point is all-cause mortality. Secondary outcomes include prostate cancer- and treatment-specific morbidity and mortality, health status, predictors of disease-specific outcomes, and cost-effectiveness. Within the first 3 years of enrollment, over 400 men have been randomized. Early analysis of participants' baseline characteristics indicate that enrollees are representative of men diagnosed with clinically localized prostate cancer throughout the United States. Therefore, results of PIVOT will be generalizable. These results are necessary in order to determine the preferred therapy for clinically localized prostate cancer.
前列腺癌干预与观察试验（PIVOT）是一项随机试验，旨在确定根治性前列腺切除术或观察等待治疗是否能为临床局限性前列腺癌男性带来更长的生存期和更高的生活质量。该试验在退伍军人事务部和国家癌症研究所的医疗中心进行，PIVOT将招募1000多名75岁以下的个体。主要研究终点是全因死亡率。次要结局包括前列腺癌及治疗特异性发病率和死亡率、健康状况、疾病特异性结局的预测因素以及成本效益。在入组的前3年里，已有400多名男性被随机分组。对参与者基线特征的早期分析表明，入组者代表了全美国被诊断为临床局限性前列腺癌的男性。因此，PIVOT的结果将具有广泛适用性。这些结果对于确定临床局限性前列腺癌的首选治疗方法是必要的。
