From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).
N Engl J Med. 2024 Sep 26;391(12):1083-1095. doi: 10.1056/NEJMoa2406050.
Data on the efficacy and safety of screening for prostate cancer with magnetic resonance imaging (MRI) are needed from studies of follow-up screening.
In a population-based trial that started in 2015, we invited men who were 50 to 60 years of age to undergo prostate-specific antigen (PSA) screening. Men with a PSA level of 3 ng per milliliter or higher underwent MRI of the prostate. Men were randomly assigned to the systematic biopsy group, in which they underwent systematic biopsy and, if suspicious lesions were found on MRI, targeted biopsy, or the MRI-targeted biopsy group, in which they underwent MRI-targeted biopsy only. At each visit, men were invited for repeat screening 2, 4, or 8 years later, depending on the PSA level. The primary outcome was detection of clinically insignificant (International Society of Urological Pathology [ISUP] grade 1) prostate cancer; detection of clinically significant (ISUP grade ≥2) cancer was a secondary outcome, and detection of clinically advanced or high-risk (metastatic or ISUP grade 4 or 5) cancer was also assessed.
After a median follow-up of 3.9 years (approximately 26,000 person-years in each group), prostate cancer had been detected in 185 of the 6575 men (2.8%) in the MRI-targeted biopsy group and 298 of the 6578 men (4.5%) in the systematic biopsy group. The relative risk of detecting clinically insignificant cancer in the MRI-targeted biopsy group as compared with the systematic biopsy group was 0.43 (95% confidence interval [CI], 0.32 to 0.57; P<0.001) and was lower at repeat rounds of screening than in the first round (relative risk, 0.25 vs. 0.49); the relative risk of a diagnosis of clinically significant prostate cancer was 0.84 (95% CI, 0.66 to 1.07). The number of advanced or high-risk cancers detected (by screening or as interval cancer) was 15 in the MRI-targeted biopsy group and 23 in the systematic biopsy group (relative risk, 0.65; 95% CI, 0.34 to 1.24). Five severe adverse events occurred (three in the systematic biopsy group and two in the MRI-targeted biopsy group).
In this trial, omitting biopsy in patients with negative MRI results eliminated more than half of diagnoses of clinically insignificant prostate cancer, and the associated risk of having incurable cancer diagnosed at screening or as interval cancer was very low. (Funded by Karin and Christer Johansson's Foundation and others; GÖTEBORG-2 ISRCTN registry number, ISRCTN94604465.).
需要来自随访筛查研究的数据来评估前列腺癌筛查中应用磁共振成像（MRI）的疗效和安全性。
在一项于 2015 年开始的基于人群的试验中，我们邀请年龄在 50 至 60 岁之间的男性接受前列腺特异性抗原（PSA）筛查。PSA 水平达到每毫升 3 纳克或更高的男性接受前列腺 MRI 检查。男性被随机分配至系统活检组，在该组中，如果 MRI 上发现可疑病变，则进行系统活检和靶向活检；或分配至 MRI 靶向活检组，仅进行 MRI 靶向活检。每次就诊时，根据 PSA 水平，男性被邀请在 2、4 或 8 年后再次进行筛查。主要结局是检测到临床意义不显著（国际泌尿病理学会 [ISUP] 分级 1）的前列腺癌；次要结局是检测到临床意义显著（ISUP 分级≥2）的癌症，同时还评估了临床进展或高危（转移性或 ISUP 分级 4 或 5）癌症的检出情况。
在中位随访 3.9 年后（每组约 26000 人年），MRI 靶向活检组的 6575 名男性中有 185 名（2.8%）和系统活检组的 6578 名男性中有 298 名（4.5%）检测到前列腺癌。与系统活检组相比，MRI 靶向活检组检测到临床意义不显著的癌症的相对风险为 0.43（95%置信区间[CI]，0.32 至 0.57；P<0.001），且在重复筛查轮次中的检出率低于首轮（相对风险，0.25 比 0.49）；临床显著前列腺癌的诊断相对风险为 0.84（95%CI，0.66 至 1.07）。通过筛查或作为间期癌检测到的高级或高危癌症数量为 15 例（MRI 靶向活检组）和 23 例（系统活检组）（相对风险，0.65；95%CI，0.34 至 1.24）。5 例发生严重不良事件（系统活检组 3 例，MRI 靶向活检组 2 例）。
在这项试验中，对 MRI 结果阴性的患者省略活检可消除一半以上的临床意义不显著前列腺癌的诊断，并且通过筛查或作为间期癌诊断出无法治愈的癌症的风险非常低。（由 Karin 和 Christer Johansson 基金会等资助；GÖTEBORG-2 ISRCTN 注册号，ISRCTN94604465。）
