Department of Urology, Skåne University Hospital, Malmö, Sweden.
Division of Urological Cancers, Department of Translational Medicine, Lund University, Malmö, Sweden.
BJU Int. 2024 Jan;133(1):87-95. doi: 10.1111/bju.16143. Epub 2023 Aug 10.
To determine the feasibility of a digitally automated population-based programme for organised prostate cancer testing (OPT) in Southern Sweden.
A pilot project for a regional OPT was conducted between September 2020 and February 2021, inviting 999 randomly selected men aged 50, 56, or 62 years. Risk stratification was based on prostate-specific antigen (PSA) level, PSA density (PSAD), and bi-parametric prostate magnetic resonance imaging (MRI). Men with a PSA level of 3-99 ng/mL had an MRI, and men with elevated PSA level (≥3 ng/mL) had a urological check-up, including a digital rectal examination and transrectal ultrasonography (TRUS). Indications for targeted and/or systematic transrectal prostate biopsies were suspicious lesions on MRI (Prostate Imaging-Reporting and Data System [PI-RADS] 4-5) and/or PSAD > 0.15 ng/mL/mL. Additional indications for prostate biopsies were palpable tumours, PSA ratio < 0.1, or cancer suspicion on TRUS. Patient selection, mail correspondence, data collection, and algorithm processing were performed by an automated digital management system. Feasibility is reported descriptively.
A total of 418 men had a PSA test (42%), with increasing participation rates by age (50 years, 38%; 56 years, 44%; and 62 years, 45%). Among these, 35 men (8%) had elevated PSA levels (≥3 ng/mL: one of 139, aged 50 years; 10/143, aged 56 years; and 24/146, aged 62 years). On MRI, 16 men (48%) had a negative scan (PI-RADS < 3), seven men (21%) had PI-RADS 3, nine men (27%) had PI-RADS 4, and one man (3%) had PI-RADS 5. All men with PI-RADS 4 or 5 underwent prostate biopsies, as well as two men with PI-RADS 3 due to PSAD > 0.15 ng/mL/mL or a suspicious finding on TRUS. Prostate cancer was diagnosed in 10 men. Six men underwent active treatment, whereas four men were assigned to active surveillance.
Our OPT model is feasible from an operational point of view, but due to the limited scale of this study no conclusions can be made regarding the efficacy of the diagnostic model or outcome.
确定在瑞典南部开展基于人群的有组织前列腺癌检测(OPT)数字化自动项目的可行性。
2020 年 9 月至 2021 年 2 月期间,开展了一项针对特定区域 OPT 的试点项目,邀请了 999 名随机选择的 50、56 或 62 岁男性。风险分层基于前列腺特异性抗原(PSA)水平、PSA 密度(PSAD)和双参数前列腺磁共振成像(MRI)。PSA 水平为 3-99ng/mL 的男性进行 MRI 检查,PSA 水平升高(≥3ng/mL)的男性进行泌尿科检查,包括直肠指检和经直肠超声(TRUS)检查。MRI 上有可疑病变(前列腺影像报告和数据系统 [PI-RADS] 4-5)和/或 PSAD>0.15ng/mL/mL 时,提示进行靶向和/或系统经直肠前列腺活检。TRUS 上发现可疑病灶、PSA 比值<0.1 或怀疑癌症时,也提示进行前列腺活检。患者选择、邮件通信、数据收集和算法处理均由自动化数字管理系统完成。可行性报告采用描述性方法。
共有 418 名男性接受了 PSA 检测(42%),随着年龄的增长(50 岁,38%;56 岁,44%;62 岁,45%),参与率也逐渐升高。其中,35 名男性(8%)PSA 水平升高(≥3ng/mL:1 名 50 岁,139 名中的 1 名;10 名 56 岁,143 名中的 10 名;24 名 62 岁,146 名中的 24 名)。MRI 检查中,16 名男性(48%)扫描结果为阴性(PI-RADS<3),7 名男性(21%)PI-RADS 为 3,9 名男性(27%)PI-RADS 为 4,1 名男性(3%)PI-RADS 为 5。所有 PI-RADS 为 4 或 5 的男性均接受了前列腺活检,PI-RADS 为 3 且 PSAD>0.15ng/mL/mL 或 TRUS 检查发现可疑病灶的 2 名男性也接受了前列腺活检。10 名男性被诊断为前列腺癌。6 名男性接受了积极治疗,4 名男性被分配进行主动监测。
从操作角度来看,我们的 OPT 模型是可行的,但由于本研究规模有限,因此无法得出关于诊断模型或结果的疗效的任何结论。