Chandra Engel Jan, Eklund Martin, Jäderling Fredrik, Palsdottir Thorgerdur, Falagario Ugo, Discacciati Andrea, Nordström Tobias
Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
Eur Urol Oncol. 2025 Apr;8(2):435-443. doi: 10.1016/j.euo.2024.10.002. Epub 2024 Oct 23.
The optimal biopsy strategy in prostate cancer screening is unknown. This study aims to assess the diagnostic effects of omitting systematic biopsies in a screening cohort.
We used data from the STHLM3-MRI trial. A total of 7609 men aged 50-74 yr were randomised to undergo magnetic resonance imaging (MRI) if having an elevated risk of prostate cancer (prostate-specific antigen [PSA] ≥3 ng/ml or Stockholm3 ≥11%). Participants with Prostate Imaging Reporting and Data System (PI-RADS) ≥3 underwent targeted and systematic biopsies. Cancer detection rates from combined and targeted-only biopsies were presented as a risk ratio (RR). Subgroup analyses were stratified by age, PSA density (PSAd), and PI-RADS. Differences in reclassification rates at radical prostatectomy were calculated.
The median age of the participants was 66 yr (interquartile range: 61-71) and PSA 3.8 ng/ml (2.9-5.8). Out of 395 men undergoing combined biopsies, 52 (13.2%) had International Society of Urological Pathology (ISUP) grade group (GG) 1 and 230 (58%) had ISUP GG ≥2 prostate cancer. Omission of systematic biopsies reduced cancer detection rates (RR of ISUP GG 1: 0.83 [95% confidence interval 0.64-1.07]; ISUP GG ≥2: 0.85 [0.81-0.90]; and ISUP GG ≥3: 0.86 [0.79-0.95]). Each case of averted ISUP GG 1 cancer was associated with 3.8 cases of missed ISUP GG ≥2 and 1.1 case of ISUP GG ≥3 cancer. Detection of fewer ISUP GG ≥2 cases than the number of avoided ISUP 1 cancer cases was observed in all subgroups when systematic biopsies were omitted. Using PSAd ≥0.05 ng/ml as a cut-off for a biopsy resulted in the same numbers of ISUP GG 1 tumours saved, with higher detection rates of ISUP GG ≥2 tumours. In 146 men undergoing radical prostatectomy, 46 (31.5%) versus 28 (19.2%) were upgraded following targeted biopsies versus a combined biopsy strategy (p < 0.05).
Complete omission of systematic biopsies in prostate cancer screening is associated with decreased detection of significant cancer, while reducing overdetection of insignificant cancer to a smaller extent. This strategy also increased the risk of histopathological misclassification.
In a prostate cancer screening setting, we examined the diagnostic effects of systematic biopsies in addition to targeted biopsies in men with suspicious magnetic resonance imaging lesions. We found that exclusion of systematic biopsies led to reduced detection of clinically significant prostate cancer. Our findings emphasise the importance of incorporating systematic biopsies alongside targeted biopsies for improved diagnostic outcomes.
前列腺癌筛查中的最佳活检策略尚不清楚。本研究旨在评估在筛查队列中省略系统性活检的诊断效果。
我们使用了来自STHLM3-MRI试验的数据。共有7609名年龄在50-74岁的男性，如果患前列腺癌风险升高（前列腺特异性抗原[PSA]≥3 ng/ml或斯德哥尔摩3风险评分≥11%），则被随机分配接受磁共振成像（MRI）检查。前列腺影像报告和数据系统（PI-RADS）≥3的参与者接受靶向活检和系统性活检。联合活检和仅靶向活检的癌症检出率以风险比（RR）表示。亚组分析按年龄、PSA密度（PSAd）和PI-RADS进行分层。计算根治性前列腺切除术中重新分类率的差异。
参与者的中位年龄为66岁（四分位间距：61-71岁），PSA为3.8 ng/ml（2.9-5.8）。在395名接受联合活检的男性中，52名（13.2%）患有国际泌尿病理学会（ISUP）1级和2级组（GG）前列腺癌，230名（58%）患有ISUP GG≥2级前列腺癌。省略系统性活检降低了癌症检出率（ISUP GG 1的RR：0.83[95%置信区间0.64-1.07]；ISUP GG≥2：0.85[0.81-0.90]；ISUP GG≥3：0.86[0.79-0.95]）。每避免一例ISUP GG 1级癌症，就会有3.8例ISUP GG≥2级癌症漏诊和1.1例ISUP GG≥3级癌症漏诊。当省略系统性活检时，在所有亚组中均观察到ISUP GG≥2级病例的检出数少于避免的ISUP 1级癌症病例数。以PSAd≥0.05 ng/ml作为活检的临界值，挽救的ISUP GG 1级肿瘤数量相同，而ISUP GG≥2级肿瘤的检出率更高。在146名接受根治性前列腺切除术的男性中，靶向活检组与联合活检策略组相比，术后病理分级上调的比例分别为46名（31.5%）和28名（19.2%）（p<0.05）。
在前列腺癌筛查中完全省略系统性活检与显著癌症的检出率降低相关，同时在较小程度上减少了对非显著癌症的过度检出。该策略还增加了组织病理学错误分类的风险。
在前列腺癌筛查环境中，我们研究了除对磁共振成像可疑病变男性进行靶向活检外，系统性活检的诊断效果。我们发现排除系统性活检会导致临床显著前列腺癌的检出率降低。我们的研究结果强调了将系统性活检与靶向活检相结合以改善诊断结果的重要性。
