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在磁共振成像引导活检时代,使用基于血液的风险预测或前列腺特异性抗原进行重复前列腺癌筛查:STHLM3-MRI随机临床试验的二次分析

Repeat Prostate Cancer Screening using Blood-based Risk Prediction or Prostate-specific Antigen in the Era of Magnetic Resonance Imaging-guided Biopsies : A Secondary Analysis of the STHLM3-MRI Randomized Clinical Trial.

作者信息

Discacciati Andrea, Abbadi Ahmad, Clements Mark S, Annerstedt Magnus, Carlsson Stefan, Grönberg Henrik, Jäderling Fredrik, Eklund Martin, Nordström Tobias

机构信息

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.

C-Medical Urology Odenplan, Stockholm, Sweden.

出版信息

Eur Urol Oncol. 2024 Nov 18. doi: 10.1016/j.euo.2024.10.016.

DOI:10.1016/j.euo.2024.10.016
PMID:39562218
Abstract

BACKGROUND AND OBJECTIVE

The use of blood-based risk prediction tools has been proposed to improve prostate cancer screening, but data on repeated screening are lacking. Our aim was to compare outcomes using the blood tests prostate-specific antigen (PSA) and Stockholm3 for repeat prostate cancer screening.

METHODS

In the population-based screening-by-invitation STHLM3-MRI trial, men aged 50-74 yr were invited to participate in screening. At 2-3 yr after the initial round, men with PSA ≥1.5 ng/ml at trial inclusion who were randomized to magnetic resonance imaging (MRI)-enhanced screening and were not diagnosed with prostate cancer after the initial round were invited for repeat screening involving analysis of PSA and Stockholm3. Biparametric 1.5-T MRI was performed in cases with PSA ≥3 ng/ml or Stockholm3 ≥0.11. Men with Prostate Imaging0Reporting and Data System ≥3 lesions were referred for targeted plus systematic biopsies. The primary outcome was Gleason ≥7 cancer. Secondary outcomes included the number of MRI scans and biopsy procedures, and detection of Gleason 6 and Gleason ≥4 + 3 cancer. Outcomes were compared using the relative positive fractions (RPF).

KEY FINDINGS AND LIMITATIONS

Of 7609 men from the initial screening round, 2078 were eligible for repeat screening and 1500 (72%) participated. For detection of Gleason ≥7 prostate cancer, the area under the receiver operating characteristic curve was 0.765 (95% confidence interval [CI] 0.725-0.805) for Stockholm3 and 0.651 (95% CI 0.601-0.701) for PSA. Stockholm3 ≥0.15 was associated with 41% fewer MRI scans in comparison to PSA ≥3 ng/ml (RPF 0.59, 95%CI 0.54-0.64), while the detection of GS ≥4 + 3 cancers was similar (RPF 1.00, 95% CI 0.78-1.29). Stockholm3 ≥0.15 detected fewer Gleason ≥7 (RPF 0.75, 95% CI 0.59-0.95) and Gleason 6 (RPF 0.73, 95% CI 0.46-1.16) cancers. Stockholm3 ≥0.11 was associated with no decrease in the number of MRI scans, but an increase of the number of cancer cases detected. Limitations include the lack of long-term outcomes.

CONCLUSIONS AND CLINICAL IMPLICATIONS

Use of the Stockholm3 test for repeated prostate cancer screening could reduce the need for MRI while maintaining detection rates for high-risk cancer.

PATIENT SUMMARY

In this study, we invited men to a second round of prostate cancer screening. We found that use of a new blood test called Stockholm3 can make screening programs more efficient by using fewer resources while still detecting aggressive cancers.

摘要

背景与目的

有人提议使用基于血液的风险预测工具来改进前列腺癌筛查,但缺乏关于重复筛查的数据。我们的目的是比较使用血液检测前列腺特异性抗原(PSA)和斯德哥尔摩3(Stockholm3)进行重复前列腺癌筛查的结果。

方法

在基于人群的受邀筛查STHLM3-MRI试验中,邀请50至74岁的男性参与筛查。在首轮筛查后2至3年,首轮纳入时PSA≥1.5 ng/ml、被随机分配至磁共振成像(MRI)强化筛查且首轮未被诊断为前列腺癌的男性受邀进行重复筛查,包括PSA和Stockholm3分析。PSA≥3 ng/ml或Stockholm3≥0.11的病例进行双参数1.5-T MRI检查。前列腺影像报告和数据系统(PI-RADS)≥3级病变的男性被转诊进行靶向加系统活检。主要结局是Gleason≥7级癌症。次要结局包括MRI扫描次数和活检程序数量,以及Gleason 6级和Gleason≥4+3级癌症的检测情况。使用相对阳性率(RPF)比较结局。

主要发现与局限性

首轮筛查的7609名男性中,2078名符合重复筛查条件,1500名(72%)参与。对于检测Gleason≥7级前列腺癌,Stockholm3的受试者工作特征曲线下面积为0.765(95%置信区间[CI] 0.725-0.805),PSA为0.651(95%CI 0.601-0.701)。与PSA≥3 ng/ml相比,Stockholm3≥0.15与MRI扫描次数减少41%相关(RPF 0.59,95%CI 0.54-0.64),而GS≥4+3级癌症的检测情况相似(RPF 1.00,95%CI 0.78-1.29)。Stockholm3≥0.15检测到的Gleason≥7级(RPF 0.75,95%CI 0.59-0.95)和Gleason 6级(RPF 0.73,95%CI 0.46-1.16)癌症较少。Stockholm3≥0.11与MRI扫描次数未减少相关,但检测到的癌症病例数增加。局限性包括缺乏长期结局数据。

结论与临床意义

使用Stockholm3检测进行重复前列腺癌筛查可减少对MRI的需求,同时维持高危癌症的检测率。

患者总结

在本研究中,我们邀请男性进行第二轮前列腺癌筛查。我们发现,使用一种名为Stockholm3的新血液检测可通过使用更少资源使筛查项目更高效,同时仍能检测出侵袭性癌症。

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