Wilt T J, Brawer M K
Department of Medicine, Minneapolis Veterans Administration Medical Center, Minnesota.
J Urol. 1994 Nov;152(5 Pt 2):1910-4. doi: 10.1016/s0022-5347(17)32413-8.
The Prostate Cancer Intervention Versus Observation Trial (PIVOT) is a randomized controlled trial sponsored by the Department of Veterans Affairs and the National Cancer Institute. PIVOT will enroll 2,000 participants from at least 80 Veterans Administration and National Cancer Institute medical centers. The purpose of PIVOT is to determine which of 2 strategies is superior for managing clinically localized prostate cancer (stage T1/T2NXM0) of all histological grades. Patients less than 75 years old will be randomized to either radical prostatectomy with early intervention for disease persistence/recurrence or expectant management with palliative therapy reserved for symptomatic or metastatic disease progression. Participants will be excluded if they have received prior therapy for prostate cancer (except transurethral resection of the prostate) or are judged not to be candidates for radical prostectomy. All patients with newly diagnosed prostate cancer will be recorded on the PIVOT screening log. Registry information will include patient age, race, prostate specific antigen level, clinical stage, histological tumor grade, initial therapy, and vital status. Patients meeting eligibility criteria will watch an information and randomization video tape developed for PIVOT. Participants will be randomized over a 3-year period and followed for a minimum of 12 years. Data collected at followup will include urological symptoms, disease and treatment related morbidity, and disease specific and overall quality of life. Evidence of symptomatic or asymptomatic disease persistence, recurrence or progression will be measured by questionnaire, physical examination, digital rectal examination, prostate specific antigen and annual bone scan. The primary study end point will be all cause mortality. Secondary outcomes will include prostate cancer and treatment specific morbidity and mortality rates, health status, predictors of disease specific outcomes and cost-effectiveness. PIVOT will provide a 90% power to detect a 15% relative decrease in all cause mortality and a 35% relative decrease in prostate cancer specific mortality rate by either treatment strategy.
前列腺癌干预与观察试验（PIVOT）是一项由退伍军人事务部和国家癌症研究所赞助的随机对照试验。PIVOT将从至少80个退伍军人管理局和国家癌症研究所的医疗中心招募2000名参与者。PIVOT的目的是确定两种策略中哪种在管理所有组织学分级的临床局限性前列腺癌（T1/T2NXM0期）方面更具优势。75岁以下的患者将被随机分配至接受根治性前列腺切除术并对疾病持续/复发进行早期干预，或接受期待性管理，仅对有症状或转移性疾病进展采用姑息治疗。如果参与者曾接受过前列腺癌治疗（经尿道前列腺切除术除外）或被判定不适合进行根治性前列腺切除术，则将被排除。所有新诊断为前列腺癌的患者都将记录在PIVOT筛查日志中。登记信息将包括患者年龄、种族、前列腺特异性抗原水平、临床分期、组织学肿瘤分级、初始治疗和生命状态。符合入选标准的患者将观看为PIVOT制作的信息及随机分组录像带。参与者将在3年内进行随机分组，并至少随访12年。随访时收集的数据将包括泌尿系统症状、疾病和治疗相关的发病率，以及疾病特异性和总体生活质量。有症状或无症状疾病持续、复发或进展的证据将通过问卷、体格检查、直肠指检、前列腺特异性抗原和年度骨扫描来衡量。主要研究终点将是全因死亡率。次要结局将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。PIVOT将有90%的把握度检测出任何一种治疗策略使全因死亡率相对降低15%，前列腺癌特异性死亡率相对降低35%。
