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

doi:10.19723/j.issn.1671-167X.2026.04.014

摘要/Abstract

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筛查组。精准筛查组：tPSA≥4 μg/L者进行bpMRI检查；若前列腺影像报告和数据系统(prostate imaging reporting and data system, PI-RADS)评分≥3分，建议行系统+靶向穿刺；若tPSA≥10 μg/L且PI-RADS < 3分，建议行系统穿刺。标准筛查组：tPSA≥4 μg/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2 251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≥4 μg/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1 266例，111例患者tPSA≥4 μg/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。

关键词: 前列腺癌, 双参数磁共振, 筛查, 前列腺特异性抗原

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, 2 251 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≥4 μg/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≥10 μg/L and PI-RADS < 3 were recommended to undergo systematic biopsy alone. In the standard screening group, participants with tPSA≥4 μg/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 intergroup comparisons were performed using the Mann-Whitney U test. Results: A total of 2 251 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≥4 μg/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=1 266), 111 (8.8%) participants had tPSA ≥4 μg/L, with a recommended biopsy rate of 8.8% (111/1 266); 26 of them underwent systematic biopsy, and 14 prostate cancer cases were detected, including 7 csPCa and 7 clinically insignificant 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 statistically 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 resources, and provides a basis for precision screening strategies.

Key words: Prostate cancer, Biparametric magnetic resonance imaging, Screening, Prostate-specific antigen

中图分类号:

R737.25

阮明健, 曹煜东, 马金超, 林晨, 王硕, 杜鹏. 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[J]. 北京大学学报（医学版）, 2026, 58(4): 779-786.

Mingjian RUAN, Yudong CAO, Jinchao MA, Chen LIN, Shuo WANG, Peng DU. Feasibility and clinical value of a prostate cancer screening model based on biparametric magnetic resonance imaging combined with prostate-specific antigen in a Chinese population[J]. Journal of Peking University (Health Sciences), 2026, 58(4): 779-786.

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Variable	Total	Precision screening group	Standard screening group	P value
Number of participants	2 251	985	1 266
Age/years，M (P₂₅, P₇₅)	68 (64, 71)	68 (64, 71)	68 (64, 71)	0.666
tPSA/(μg/L), M (P₂₅, P₇₅)	1.32 (0.78, 2.30)	1.34 (0.77, 2.42)	1.31 (0.79, 2.25)	0.814
Recommended for biopsy, n(%)	140 (6.2)	29 (2.9)	111 (8.8)
Actual biopsy performed	46	20	26
PCa, n(%)				0.141
Yes	29 (63.0)	15 (75.0)	14 (53.8)
No	17 (37.0)	5 (25.0)	12 (46.2)
csPCa, n(%)				0.004
Yes	21 (45.7)	14 (70.0)	7 (26.9)
No	25 (54.3)	6 (30.0)	19 (73.1)
PCa detection rate/%	1.29	1.52	1.11	0.384
csPCa detection rate/%	0.93	1.42	0.55	0.033

Variable	Total	Precision screening group	Standard screening group	P value
PCa, n	29	15	14
ISUP grade				0.012
1	8 (27.6)	1 (6.7)	7 (50.0)
2-3	10 (34.5)	5 (33.3)	5 (35.7)
4-5	11 (37.9)	9 (60.0)	2 (14.3)
Clinical T stage
T1-T2	17 (58.6)	8 (53.3)	9 (64.3)	0.550
T3-T4	12 (41.4)	7 (46.7)	5 (35.7)
Clinical N stage
N0	27 (93.1)	13 (86.7)	14 (100.0)	0.483
N1	2 (6.9)	2 (13.3)	0 (0)
Clinical M stage
M0-Mx	27 (93.1)	13 (86.7)	14 (100.0)	0.483
M1	2 (6.9)	2 (13.3)	0 (0)
Treatment selection, n (%)				0.170
Radical surgery	21 (72.4)	10 (66.7)	11 (78.6)
Radiotherapy	1 (3.4)	1 (6.7)	0 (0)
Active surveillance	4 (13.8)	1 (6.7)	3 (21.4)
Systemic therapy	3 (10.3)	3 (2.0)	0 (0)