Department of Molecular Medicine, Aarhus University Hospital, Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark.
Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark; Department of Radiology, Aarhus University Hospital, Aarhus N, Denmark.
Eur Urol Oncol. 2023 Oct;6(5):484-492. doi: 10.1016/j.euo.2023.07.006. Epub 2023 Aug 1.
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.
DESIGN, SETTING, AND PARTICIPANTS: 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 STHLM3 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 STHLM3 test versus PSA ≥3 ng/ml. Post hoc analysis was performed using a higher STHLM3 test cutoff (risk ≥15%; positive STHLM3 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 STHLM3 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%). STHLM3 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 STHLM3 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.
目前，前列腺癌（PC）的治疗缺乏生物标志物检测和诊断程序，无法在疾病早期准确区分具有临床意义和无临床意义的 PC。
在一项前列腺癌诊断的前瞻性研究中，比较斯德哥尔摩 3 项测试（STHLM3）和前列腺特异性抗原（PSA）作为磁共振成像（MRI）的初始检测。
设计、地点和参与者：参与者为年龄在 50-69 岁的初次活检的男性，在普通诊所进行 PSA 检测。PSA 为 1-10ng/ml 的患者还进行了 STHLM3 测试，如果 STHLM3 测试结果为阳性（风险≥11%）和/或 PSA≥3ng/ml，则将其转诊进行 MRI，如果其前列腺成像报告和数据系统（PI-RADS）评分≥3，则进行靶向 MRI 引导活检（MRGB）。
主要结局是通过阳性 STHLM3 测试检测到国际泌尿病理学会分级组≥2（GG≥2）病例的数量，而不是 PSA≥3ng/ml。使用更高的 STHLM3 测试截止值（风险≥15%；阳性 STHLM3 测试）进行了事后分析。
2018 年 1 月至 2021 年 12 月，我们招募了 1905 名男性。在 1134 名参与者中进行了 STHLM3 测试。其中，437 名患者进行了 MRI 检查，117 名患者进行了 MRGB 检查，检测到 38 例（32.5%）GG≥2 和 52 例（44.4%）GG 1 例。与 PSA≥3ng/ml 相比，阳性 STHLM3 测试将 GG≥2 的检出率从 30 例增加到 37 例（23.3%，95%CI 5.6-52.2%），将 GG 1 检出率从 37 例增加到 50 例（35.1%，95%CI 11.6-66.7%）。阳性 STHLM3 与 PSA≥3ng/ml 相比，在检测 GG≥2 PC（30 与 32；6.6%，95%CI-8.1%至 25.9%）、GG 1 PC（37 与 37；0.0%，95%CI-19.6%至 25.0%）或 MRGB 使用（88 与 83；-5.7%，95%CI-17.9%至 7.4%）方面无差异，但减少了 320 次 MRI 扫描至 236 次（-26.2%，95%CI-33.1%至-18.9%）。
在普通诊所非系统性 PC 检测的临床环境中，STHLM3 测试提高了 GG≥2 PC 的检测敏感性，但特异性未提高。需要进一步的研究来验证使用较高的 STHLM3 阳性作为 MRI 检测的初始检测的可能益处。
我们在普通诊所使用一种名为 STHLM3 的测试来检测前列腺癌，并将其与常规的 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%或以上，在选择男性进行 MRI（磁共振成像）扫描方面，并不优于 PSA 测试，PSA 测试的截止值为 3ng/ml 或以上。分析表明，阳性 STHLM3 测试的较高截止值可能会改善男性接受 MRI 扫描的选择，但需要进一步验证。
