Prostate-specific Antigen Density as a Selection Tool Before Magnetic Resonance Imaging in Prostate Cancer Screening: An Analysis from the STHLM3MRI Randomized Clinical Trial.

IF 5.6 2区医学 Q1 UROLOGY & NEPHROLOGY

European urology focus Pub Date : 2025-07-29 DOI:10.1016/j.euf.2025.06.008

Lars Björnebo, Andrea Discacciati, Ahmad Abbadi, Ugo Giovanni Falagario, Jan Chandra Engel, Hari T Vigneswaran, Fredrik Jäderling, Henrik Grönberg, Martin Eklund, Anna Lantz, Tobias Nordström

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引用次数: 0

Abstract

Background and objective: Prostate cancer screening is challenged by overdetection, overtreatment, and high resource use. Prostate-specific antigen (PSA) density (PSAD) correlates more strongly with clinically significant cancer than PSA alone. We compare outcomes using various PSAD cutoffs to select men for magnetic resonance imaging (MRI).

Methods: STHLM3MRI is a screening-by-invitation trial with 49 118 men invited and 12 750 screened. In the experimental arm, participants with elevated PSA (≥3 ng/ml) had MRI and, if positive [PI-RADS] score ≥3), systematic and targeted biopsies. Evaluated PSAD cutoffs were 0.075, 0.10, 0.125, and 0.15 ng/ml². Prostate volume was measured by MRI or transrectal ultrasound. The primary endpoint was Gleason ≥3 + 4 cancer detection. The secondary endpoints were Gleason 6 and ≥4 + 3 cancer detection, and the number of MRI scans and biopsies. Relative positive fractions (RPFs) compared the outcomes using PSA ≥3 ng/ml alone.

Key findings and limitations: Of 7609 men in the experimental arm, 929 (12.2%) had PSA ≥3 ng/ml, and 846 (91%) underwent MRI, with 38% having a PI-RADS score of ≥3. The median prostate volume was 45 ml (interquartile range [IQR], 33-62 ml) and PSAD 0.10 ng/ml² (IQR, 0.07-0.14 ng/ml²). A PSAD cutoff of 0.075 ng/ml² reduced Gleason 6 cancer detection by 17% (RPF, 0.83; 95% confidence interval [CI], 0.72-0.96), lowered MRI use by 28% (RPF, 0.72; 95% CI, 0.69-0.75), and missed 5% (RPF, 0.95; 95% CI, 0.92-0.98) of Gleason ≥3 + 4 cancer cases, with no difference in Gleason ≥4 + 3 cancer detection. Higher PSAD thresholds reduced Gleason 6 cancer detection and MRI use, but lowered Gleason ≥3 + 4 cancer detection. Limitations include assumed equivalency between MRI and ultrasound volume.

Conclusions and clinical implications: The use of PSAD before MRI lowers overdiagnosis and resource use, while maintaining detection of significant cancer cases. Our results suggest that a PSAD cutoff above 0.075 ng/ml² is not advisable, regardless of age, due to the increased risk of missing cancer cases with Gleason scores ≥3 + 4.

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前列腺特异性抗原密度作为前列腺癌磁共振成像筛查前的选择工具：来自STHLM3MRI随机临床试验的分析

背景与目的：前列腺癌筛查面临着过度检测、过度治疗和资源过度使用的挑战。前列腺特异性抗原（PSA）密度（PSAD）与临床显著性癌症的相关性比单独PSA更强。我们比较了使用不同的PSAD截止值来选择男性进行磁共振成像（MRI）的结果。方法：STHLM3MRI是一项邀请筛选试验，邀请了49 118名男性，筛选了12 750名。在实验组中，PSA升高（≥3ng /ml）的参与者进行MRI检查，如果PI-RADS评分≥3)呈阳性，则进行系统和靶向活检。评估的PSAD截止值分别为0.075、0.10、0.125和0.15 ng/ml2。通过MRI或经直肠超声测量前列腺体积。主要终点为Gleason≥3 + 4癌检测。次要终点是Gleason 6和≥4 + 3癌检测，以及MRI扫描和活检次数。相对阳性分数（RPFs）比较单独使用PSA≥3 ng/ml的结果。主要发现和局限性：在实验组的7609名男性中，929名（12.2%）PSA≥3ng /ml， 846名（91%）接受了MRI检查，其中38%的PI-RADS评分≥3。前列腺体积中位数为45 ml（四分位数范围[IQR]， 33-62 ml）， PSAD为0.10 ng/ml2 （IQR, 0.07-0.14 ng/ml2）。PSAD切断0.075 ng/ml2可使Gleason 6癌检出率降低17% (RPF, 0.83；95%可信区间[CI]， 0.72-0.96)，降低了28%的MRI使用(RPF, 0.72；95% CI, 0.69-0.75)，遗漏5% (RPF, 0.95；Gleason≥3 + 4癌的95% CI为0.92-0.98)，而Gleason≥4 + 3癌的检出率差异无统计学意义。较高的PSAD阈值降低了Gleason 6癌的检出率和MRI的使用，但降低了Gleason≥3 + 4癌的检出率。局限性包括假定MRI和超声体积相等。结论和临床意义：MRI前使用PSAD降低了过度诊断和资源使用，同时保持了对重要癌症病例的检测。我们的研究结果表明，PSAD临界值高于0.075 ng/ml2是不可取的，无论年龄如何，因为Gleason评分≥3 + 4时遗漏癌症病例的风险增加。

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来源期刊

European urology focus Medicine-Urology

CiteScore

10.40

自引率

3.70%

发文量

274

审稿时长

23 days

期刊介绍： European Urology Focus is a new sister journal to European Urology and an official publication of the European Association of Urology (EAU). EU Focus will publish original articles, opinion piece editorials and topical reviews on a wide range of urological issues such as oncology, functional urology, reconstructive urology, laparoscopy, robotic surgery, endourology, female urology, andrology, paediatric urology and sexual medicine. The editorial team welcome basic and translational research articles in the field of urological diseases. Authors may be solicited by the Editor directly. All submitted manuscripts will be peer-reviewed by a panel of experts before being considered for publication.