跳至主要内容
临床试验/NCT07206693
NCT07206693已完成不适用

Impact of PSA-based Screening on Mortality Among Men Aged 75-79: Target Trial Emulation

Karolinska Institutet0 个研究点目标入组 257,275 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
257,275
主要终点
All-cause mortality

研究概览

简要总结

Opportunistic prostate-specific antigen (PSA) testing is widespread among men aged 75-79. Current American and European guidelines recommend PSA-based screening through shared decision-making if men are expected to live at least 10 more years-a threshold previously tied to ages 70-74. With rising life expectancy, Swedish men aged 75-79 now exceed this benchmark, averaging over 10 years.

Since no randomized controlled trials have examined screening in this age group, this study will use data from the Stockholm Prostate Cancer Diagnostics Register (2007-2023) to emulate a target trial. Men without prior prostate cancer will be assigned to screened or unscreened groups based on PSA test records and followed until death or December 2023. Analyses will use survival models, cumulative incidence functions, and sensitivity checks (e.g., varying follow-up duration, calendar year vs. age enrollment, and comparisons with men aged 65-69).

The goal is to determine whether PSA screening at ages 75-79 improves overall and prostate cancer-specific survival, and whether guidelines should expand to include this group while balancing the risk of overdiagnosis. Results will inform both clinical practice and the design of future randomized trials.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
75 Years 至 79 Years(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men aged 75-79 between 2007-2023, with no prostate cancer diagnosis at the time of inclusion (based on each trial emulation) will be considered eligible for the trials. To ensure proper control for potential confounding, and to be able to evaluate the eligibility criteria, only men with complete information on their screening status, outcomes, and confounders in the registers will be included.

排除标准

  • Men younger than 75 or older than 79 between 2007-
  • Have prostate cancer diagnosis at the time of inclusion (based on each trial emulation) Missing data on the exposure, outcomes, and confounders.

结局指标

主要结局

All-cause mortality

时间窗: 17 years

Prostate-cancer specific mortality

时间窗: 17 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tobias Nordström

MD PhD

Karolinska Institutet

相似试验