基于双参数磁共振成像联合前列腺特异性抗原的前列腺癌筛查模式在中国人群中的可行性与临床价值

Feasibility and clinical value of a prostate cancer screening model based on bipara- metric magnetic resonance imaging combined with prostate-specific antigen in a Chinese population

摘要

目的：探讨总前列腺特异性抗原（total prostate-specific antigen，tPSA）联合双参数磁共振成像（biparametric magnetic resonance imaging，bpMRI）的前列腺癌筛查模式在中国人群中的可行性与临床价值。方法：纳入北京市3家社区卫生服务中心 2024 年 5 月至 2025 年 5 月 50 岁及以上男性作为研究对象，按 2:1 比例随机分为精准筛查组与标准篮查组。精准篮查组：tPSA ⩾4μ g/L 者进行 bpMRI 检查；若前列腺影像报告和数据系统（prostate imagingreporting and data system，PI-RADS）评分 ⩾3 分，建议行系统＋靶向穿刺；若 tPSA ⩾10μ g/L 且 PI-RADS<3 分，建议行系统穿刺。标准筛查组：tPSA ⩾4μ g/L 者建议行系统穿刺。记录两组实际接受穿刺人数，穿刺阳性率和 Gleason评分一致率。主要结局指标为临床有意义前列腺癌（clinically significant prostate cancer，csPCa）检出率，组间比较采用卡方检验。结果：共2251名男性纳入分析，中位年龄68岁（57~90岁）。精准筛查组985例，115例（11.7％）受试者 tPSA ⩾4μ g/L ，其中30例接受了 bpMRI 检查，建议穿刺率为2.9％（29/985），实际接受前列腺穿刺者20例，最终检出前列腺癌 15 例，包括 14 例临床有意义前列腺癌（csPCa）和 1 例临床无意义前列腺癌。标准筛查组 1266例，111例患者 tPSA ⩾4μ g/L ，建议穿刺率为 8.8％，其中26例接受系统穿刺，共检出14例前列腺癌，包括7例csPCa 和7例临床无意义前列腺癌。精准筛查组的总体穿刺阳性率为75.0％，与标准筛查组（58.3％）相比，差异无统计学意义（P=0.141）；而精准筛查组 csPCa 穿刺阳性率（70.0%）显著高于标准筛查组（26.9%），差异有统计学意义（P=0.004）。确诊的 29 例前列腺癌患者中，局灶期 17 例（58.6%）、局部进展期 10 例（34.5%）、转移性2 例（6.9%）。在接受根治手术的 21 例患者中，精准筛查组穿刺标本与术后病理 Gleason 评分一致率为 70.0% ，高于标准筛查组（36.4%），但差异无统计学意义（P=0.198）。结论：基于血清 tPSA 联合 bpMRI 的前列腺癌筛查模式具有可行性，可减少不必要的穿刺，优化筛查资源配置，可为精准筛查提供依据。

Abstract

Objective：To evaluate the feasibility and clinical value of a prostate cancer screening model incorporating total prostate-specific antigen（tPSA）and biparametric magnetic resonance imaging （bpMRI）in a Chinese population. Methods：Between May 2024 and May 2025， 2251 men aged 50 years or older from three community health service centers in Beijing were enrolled，who were randomly assigned to the precise screening group and the standard screening group in a 2 ： 1 ratio in the community health service centers.In the precision screening group，participants with tPSA ⩾4μ g/L underwent bpMRI；those with a prostate imaging reporting and data system（PI-RADS）score ⩾3 were recommended to undergo systematic combined with targeted biopsy，while those with tPSA⩾10μ g/L and PI-RADS <3 were recommended to undergo systematic biopsy alone.In the standard screening group，participants with tPSA⩾4μ g/L were recommended to undergo systematic biopsy.The number of participants who actually underwent biopsy，biopsy positivity rate，and Gleason score concordance rate was recorded.The primary outcome measure was the detection rate of clinically significant prostate cancer（csPCa），and the inter- group comparisons were performed using the Mann-Whitney U test. Results：A total of 2251 men were included in the analysis，with a median age of 68 years（range：57-90 years）.In the precision screening group (n=985),115(11.7%) participants had tPSA⩾4μ g/L ，of whom 30 underwent bpMRI.The recommended biopsy rate was 2.9%（29/985），and 20 participants actually underwent prostate biopsy.A total of 15 prostate cancer cases were detected，including 14 csPCa and one clinically insignificant prostate cancer.In the standard screening group (n=1266),111(8.8%) participants had tPSA ⩾4μ g/L ，with a recommended biopsy rate of 8.8％（111/1 266）； 26 of them underwent sys- tematic biopsy，and 14 prostate cancer cases were detected，including 7 csPCa and 7 clinically insignifi- cant prostate cancer.The overall positive biopsy rate in the precision screening group was 75.0% ，which was not statistically significant compared with that in the standard screening group（58.3％，P= 0.141).However，the csPCa detection rate in the precision screening group reached 70.0% ，which was significantly higher than that in the standard screening group（26.9％），and the difference was statisti- cally significant (P=0.004).Among the 29 diagnosed prostate cancer patients， 17 （58.6%）had localized disease， 10 （34.5％）had locally advanced disease，and 2 （6.9％）had metastatic disease. Among the 21 patients who underwent radical surgery，the concordance rate between biopsy and post- operative pathological Gleason scores was 70.0% in the precision screening group，higher than that in the standard screening group（36.4％），although the difference was not statistically significant (P= 0.198). Conclusion：The prostate cancer screening model based on serum tPSA combined with bpMRI demonstrates good feasibility，reduces unnecessary biopsies，optimizes the allocation of screening re- sources，and provides a basis for precision screening strategies.

关键词

前列腺癌 / 双参数磁共振 / 筛查 / 前列腺特异性抗原

Key words

Prostate cancer / Biparametric magnetic resonance imaging / Screening / Prostate-specific antigen

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基金资助

首都卫生发展科研专项重点项目(2022-1G-1021)

国家外国专家项目(H20240719)

北京市医院管理中心创新梦工场经费(202325)

北京市医院管理局登峰人才计划(DFL20241101)