Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
JAMA Netw Open. 2024 Feb 5;7(2):e2354577. doi: 10.1001/jamanetworkopen.2023.54577.
Magnetic resonance imaging (MRI) has been proposed to enhance the benefit-to-harm ratio of prostate cancer screening, but data on repeated screening outcomes are lacking.
To describe outcomes of prostate-specific antigen (PSA)-based screening with MRI and prostate biopsies at repeat screening.
DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis examined the population-based, screen-by-invitation STHLM3-MRI randomized clinical trial, which recruited Swedish men aged 50 to 74 years. Men were eligible for repeat screening at 2 to 3 years if they had PSA levels of 1.5 ng/mL or greater at trial inclusion, were randomized to the MRI-targeted group (including screening using biomarkers and MRI), and were not diagnosed with prostate cancer after the first screening round. Repeat screening was performed between November 10, 2021, and February 20, 2023. Data analysis was performed between May and August 2023.
Participants underwent blood sampling, including PSA testing. A biparametric MRI scan was performed if PSA levels were 3 ng/mL or greater, and men with lesions with a Prostate Imaging-Reporting and Data System (PI-RADS) score of 3 or greater were referred for targeted and systematic biopsies.
The primary outcome was clinically significant prostate cancer (Gleason score of ≥3 + 4). Secondary outcomes included the proportion of men with clinically insignificant cancer (Gleason score of 6), the number of elevated PSA tests, MRI scans, and biopsy procedures.
Of 7609 men from the first screening round, 2078 (27.3%) were eligible for and were invited for rescreening. Among the invitees, 1500 (72.2%) participated. Their median age was 67 (IQR, 61-72) years. Of 1094 men with PSA levels between 1.5 and 2.9 ng/mL in the first screening round, 326 (29.8%) had levels of 3 ng/mL or greater in the second round. Overall, 667 men (44.5%) had PSA levels of 3 ng/mL or greater: 617 underwent MRI (92.5%), revealing 51 (7.6%) with equivocal lesions (PI-RADS score of 3) and 33 (4.9%) with suspicious lesions (PI-RADS score of ≥4). Only 10 of 383 men (2.6%) with a prior negative MRI result had a lesion with a PI-RADS score of 4 or greater. Among the 1500 rescreened men, 48 (3.2%) had a Gleason score of 3 + 4 or greater, including 19 (1.3%) with a score of 4 + 3 or greater and 11 (0.7%) with a score of 6.
In this secondary analysis of the STHLM3-MRI randomized clinical trial, cancer detection during the second screening round in biennial PSA and MRI-based prostate cancer screening was limited, and the detection of low-grade tumors remained low. A substantial proportion of men exhibited elevated PSA levels during rescreening, and a considerable portion of MRI scans performed lacked lesions suggestive of cancer. Future studies should explore strategies to reduce MRI-related resource use.
ClinicalTrials.gov Identifier: NCT03377881.
磁共振成像（MRI）已被提议提高前列腺癌筛查的获益-危害比，但缺乏关于重复筛查结果的数据。
描述基于前列腺特异性抗原（PSA）的筛查与 MRI 和前列腺活检在重复筛查中的结果。
设计、地点和参与者：这项二次分析研究了基于人群的、邀请参加的 STHLM3-MRI 随机临床试验，该试验招募了年龄在 50 至 74 岁之间的瑞典男性。如果男性在试验纳入时 PSA 水平为 1.5ng/ml 或更高，被随机分配到 MRI 靶向组（包括使用生物标志物和 MRI 进行筛查），并且在第一轮筛查后未被诊断为前列腺癌，则有资格进行重复筛查。重复筛查于 2021 年 11 月 10 日至 2023 年 2 月 20 日进行。数据分析于 2023 年 5 月至 8 月进行。
参与者接受了包括 PSA 检测在内的血液采样。如果 PSA 水平为 3ng/ml 或更高，则进行双参数 MRI 扫描，如果有前列腺成像报告和数据系统（PI-RADS）评分 3 或更高的病变，则进行靶向和系统活检。
主要结果是临床显著的前列腺癌（Gleason 评分≥3+4）。次要结果包括有临床意义较小的癌症（Gleason 评分 6）的男性比例、升高的 PSA 检测、MRI 扫描和活检程序的数量。
在第一轮筛查的 7609 名男性中，有 2078 名（27.3%）有资格并被邀请进行重新筛查。在受邀者中，有 1500 人（72.2%）参加了。他们的中位年龄为 67（IQR，61-72）岁。在第一轮筛查中 PSA 水平在 1.5 至 2.9ng/ml 之间的 1094 名男性中，有 326 名（29.8%）在第二轮筛查中 PSA 水平为 3ng/ml 或更高。总体而言，有 667 名男性（44.5%）PSA 水平为 3ng/ml 或更高：617 名接受了 MRI（92.5%），发现 51 名（7.6%）有可疑病变（PI-RADS 评分 3）和 33 名（4.9%）有可疑病变（PI-RADS 评分≥4）。在先前 MRI 结果为阴性的 383 名男性中，仅有 10 名（2.6%）有 PI-RADS 评分 4 或更高的病变。在 1500 名重新筛查的男性中，有 48 名（3.2%）有 Gleason 评分 3+4 或更高，包括 19 名（1.3%）有评分 4+3 或更高，11 名（0.7%）有评分 6。
在 STHLM3-MRI 随机临床试验的这项二次分析中，在基于 PSA 和 MRI 的前列腺癌筛查的第二轮筛查中，癌症的检出率有限，低级别肿瘤的检出率仍然较低。相当一部分男性在重新筛查期间出现 PSA 水平升高，相当一部分进行的 MRI 扫描缺乏提示癌症的病变。未来的研究应探讨减少 MRI 相关资源使用的策略。
ClinicalTrials.gov 标识符：NCT03377881。
