Division of Personalized Early Detection of Prostate Cancer, German Cancer Research Center (DKFZ), Heidelberg, Germany.
Department of Urology, University Hospital, Medical Faculty, Heinrich-Heine University Duesseldorf, Duesseldorf, Germany.
Eur Urol Oncol. 2023 Dec;6(6):566-573. doi: 10.1016/j.euo.2023.09.008. Epub 2023 Oct 6.
Annual digital rectal examination (DRE) is recommended as a stand-alone screening test for prostate cancer (PCa) in Germany for 45+ yr olds. DRE diagnostic performance in men as young as 45 yr old has not been proved by a screening trial.
To determine DRE diagnostic performance in a screening trial.
DESIGN, SETTING, AND PARTICIPANTS: This analysis was conducted within the multicentric, randomized PROBASE trial, which enrolled >46 000 men at age 45 to test risk-adapted prostate-specific antigen (PSA) screening for PCa.
(1) DRE was analyzed as a one-time, stand-alone screening offer at age 45 in 6537 men in one arm of the trial and (2) PCa detection by DRE was evaluated at the time of PSA-screen-driven biopsies (N = 578).
(1) True-/false-positive detection rates of DRE as compared with PSA screening and (2) DRE outcome at the time of a prostate biopsy were evaluated.
(1) A prospective analysis of 57 men with suspicious DRE at age 45 revealed three PCa. Detection rate by DRE was 0.05% (three of 6537) as compared with a four-fold higher rate by PSA screening (48 of 23 301, 0.21%). The true-positive detection rate by DRE relative to screening by PSA was 0.22 (95% confidence interval [CI] = [0.07-0.72]) and the false-positive detection rate by DRE was 2.2 (95% CI = [1.50-3.17]). (2) Among PSA-screen-detected PCa cases, 86% had unsuspicious DRE (sensitivity relative to PSA was 14%), with the majority of these tumors (86%) located in the potentially accessible zones of the prostate as seen by magnetic resonance imaging.
The performance of stand-alone DRE to screen for PCa is poor. DRE should not be recommended as a PCa screening test in young men. Furthermore, DRE does not improve the detection of PSA-screen-detected PCa.
Our report demonstrated the poor diagnostic performance of digital rectal examination in the screening for prostate cancer in young men.
在德国，建议 45 岁以上的男性每年进行数字直肠检查（DRE）作为前列腺癌（PCa）的独立筛查试验。但尚未通过筛查试验证明 45 岁以下男性的 DRE 诊断性能。
确定 DRE 在筛查试验中的诊断性能。
设计、地点和参与者：本分析是在多中心、随机的 PROBASE 试验中进行的，该试验招募了 46000 多名 45 岁的男性，以测试基于前列腺特异性抗原（PSA）的风险适应型筛查是否可用于 PCa。
（1）在试验的一个臂中，6537 名男性在 45 岁时一次性进行 DRE 筛查；（2）在 PSA 筛查驱动的活检时评估 DRE 检测到的 PCa（N=578）。
（1）与 PSA 筛查相比，DRE 的真阳性/假阳性检出率；（2）在前列腺活检时的 DRE 结果。
（1）对 45 岁时 DRE 可疑的 57 名男性进行前瞻性分析，发现 3 例 PCa。DRE 的检出率为 0.05%（6537 例中有 3 例），而 PSA 筛查的检出率高 4 倍（23301 例中有 48 例，0.21%）。与 PSA 筛查相比，DRE 的真阳性检出率为 0.22（95%置信区间[CI]为[0.07-0.72]），DRE 的假阳性检出率为 2.2（95%CI为[1.50-3.17]）。（2）在 PSA 筛查检测到的 PCa 病例中，86%的 DRE 无异常（相对于 PSA 的敏感性为 14%），其中大多数肿瘤（86%）位于 MRI 可见的前列腺潜在可触及区域。
单独使用 DRE 筛查 PCa 的性能较差。不建议将 DRE 用于年轻男性的 PCa 筛查。此外，DRE 并不能提高 PSA 筛查检测到的 PCa 的检出率。
我们的报告表明，在年轻男性的前列腺癌筛查中，DRE 的诊断性能较差。
