目前前列腺癌（PC）的管理缺乏可以准确区分临床显著和临床不显著PC的生物标志物测试和诊断程序，尤其是在疾病的早期阶段。本前瞻性研究旨在比较斯德哥尔摩3（STHLM3）测试和前列腺特异性抗原（PSA）作为一般临床实践中磁共振成像（MRI）入口测试的前列腺癌诊断情况。参与者为50-69岁的无既往活检的男性，他们在一般临床实践中接受了PSA测试。PSA为1-10 ng/ml的参与者还接受了STHLM3测试，并且如果STHLM311测试结果为阳性（风险≥11%）和/或PSA ≥ 3 ng/ml，则转诊至MRI；如果他们的前列腺成像报告和数据系统（PI-RADS）评分≥ 3，则进行MRI引导的靶向活检（MRGB）预约。主要结果是通过STHLM311测试与PSA ≥ 3 ng/ml相比，在检测到国际泌尿外科病理学等级组≥ 2（GG ≥ 2）的病例数量方面的差异。事后分析使用更高的STHLM3测试截断（风险≥15%，即STHLM315测试为阳性）。2018年1月至2021年12月，我们招募了1905名男性。STHLM3测试共在1134名参与者中进行。其中，437名接受了MRI检查，117名接受了MRGB检查，检测出38例（32.5%）GG ≥ 2病例和52例（44.4%）GG 1病例。与PSA ≥ 3 ng/ml相比，STHLM311测试阳性结果将GG ≥ 2的检出病例数从30增加到37（23.3%，95%置信区间[CI] 5.6-52.2%），GG 1的检出病例数从37增加到50（35.1%，95%CI 11.6-66.7%）。与PSA ≥ 3 ng/ml相比，STHLM315阳性结果在检测GG ≥ 2 PC（30 vs 32，6.6%，95%CI -8.1%-25.9%）和GG 1 PC（37 vs 37，0%，95% CI -19.6%-25.0%）以及MRGB使用（88 vs 83，-5.7%，95% CI -17.9%-7.4%）方面无差异，但将MRI扫描减少至236个（-26.2%，95% CI -33.1%-18.9%）。STHLM311测试提高了临床实践中无系统前列腺癌测试的GG ≥ 2 PC的敏感性，但对特异性没有改进。还需要进行进一步研究来验证STHLM3阳性的更高截断值作为入口测试MRI的潜在益处。 我们在一般临床实践中使用了一种名为STHLM3的测试来检测前列腺癌，并将其表现与常规的PSA（前列腺特异性抗原）测试进行了比较。我们发现，STHLM3测试结果为11%或更高时，在选择接受MRI扫描的男性方面并不比PSA测试结果为3 ng/ml或更高时更好。分析结果显示，将STHLM3阳性测试的更高截断值可能会改善男性接受MRI扫描的筛选效果，但仍需要进一步验证。 版权所有 © 2023 作者。由 Elsevier B.V. 发布。保留所有权利。

Current management of prostate cancer (PC) lacks biomarker tests and diagnostic procedures that can accurately distinguish clinically significant and clinically insignificant PCs at an early stage of the disease.To compare the Stockholm 3 (STHLM3) test and prostate-specific antigen (PSA) as entry tests for magnetic resonance imaging (MRI) in a prospective study of PC diagnosis in general practice.Participants were biopsy-naïve men aged 50-69 yr who had a PSA test in general practice. Participants with PSA 1-10 ng/ml also had an STHLM3 test and were referred for MRI if the STHLM311 test was positive (risk ≥11%) and/or PSA ≥3 ng/ml, and to targeted MRI-guided biopsy (MRGB) if their Prostate Imaging-Reporting and Data System (PI-RADS) score was ≥3.The primary outcome was the number of International Society of Urological Pathology grade group ≥2 (GG ≥2) cases detected with a positive STHLM311 test versus PSA ≥3 ng/ml. Post hoc analysis was performed using a higher STHLM3 test cutoff (risk ≥15%; positive STHLM315 test).Between January 2018 and December 2021, we recruited 1905 men. The STHLM3 test was performed in 1134 participants. Of these, 437 underwent MRI and 117 underwent MRGB, which detected 38 (32.5%) GG ≥2 and 52 (44.4%) with GG 1 cases. In comparison to PSA ≥3 ng/ml, a positive STHLM311 test increased detection of GG ≥2 from 30 to 37 cases (23.3%, 95% confidence interval [CI] 5.6-52.2%) and detection of GG 1 from 37 to 50 cases (35.1%, 95%CI 11.6-66.7%). STHLM315 positivity did not differ from PSA ≥3 ng/ml regarding detection of GG ≥2 PC (30 vs 32; 6.6%, 95% CI -8.1% to 25.9%), GG 1 PC (37 vs 37; 0.0%, 95% CI -19.6% to 25.0%), or MRGB use (88 vs 83; -5.7%, 95% CI -17.9% to 7.4%), but reduced MRI scans from 320 to 236 (-26.2%, 95% CI -33.1% to -18.9%).The STHLM311 test improved sensitivity but not specificity for detection of GG ≥2 PC in the clinical setting of nonsystematic PC testing in general practice. Further studies are needed to validate a possible benefit of using a higher cutoff for STHLM3 positivity as an entry test for MRI.We used a test called STHLM3 for detection of prostate cancer in general practice and compared its performance to the conventional PSA (prostate-specific antigen) test. We found that STHLM3 test results of 11% or above were not better at selecting men for MRI (magnetic resonance imaging) scans than the PSA test with a cutoff of 3 ng/ml or above. Analysis suggested that a higher cutoff for a positive STHLM3 test may improve selection of men for MRI scans, but further validation is needed.Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.