瑞典卡罗林斯卡医学院Martin Eklund团队比较了MRI靶向或标准活检在前列腺癌筛查中的应用效果。相关论文于2021年7月9日发表在《新英格兰医学杂志》上。

高比率过度诊断是规模前列腺癌筛查的一个关键障碍。磁共振成像（MRI）和靶向活检显示了解决这一挑战的潜力，但其在规模前列腺癌筛查中的应用尚不清楚。

研究组进行了一项以人群为基础的前列腺癌筛查非劣效性试验，通过邮件邀请普通人群中50至74岁的男性参与，将前列腺特异性抗原（PSA）水平为3 ng/mL或更高的受试者按2：3的比例随机分组，分别接受标准活检（标准活检组）或MRI，若MRI结果显示前列腺癌，则进行靶向和标准活检（实验活检组）。主要结局是意向治疗男性人群中有临床意义的癌症（Gleason评分≥7） 的诊出率，关键次要结局是临床上无意义癌症（Gleason评分为6）的检出率。

12750名男性中有1532名PSA水平为3 ng/mL或更高，将其随机分配活检，其中603名被分配到标准活检组，929名被分配到实验活检组。在意向治疗分析中，实验活检组中有192名男性（21%）被诊断为具有临床意义的癌症，而标准活检组中有106名男性（18%）。实验活检组中有41名男性被诊断为无临床意义的癌症（4%），显著低于标准活检组（73名，12%）。

研究结果表明，在这项以人群为基础的邀请筛查试验中，对MRI结果提示前列腺癌的男性患者进行靶向和标准活检，在检测具有临床意义的前列腺癌方面不劣于标准活检，且减少了无临床意义癌症的检出率。

附：英文原文

Title: MRI-Targeted or Standard Biopsy in Prostate Cancer Screening | NEJM

Author: Martin Eklund, Ph.D.,, Fredrik Jderling, M.D., Ph.D.,, Andrea Discacciati, Ph.D.,, Martin Bergman, M.D.,, Magnus Annerstedt, M.D.,, Markus Aly, M.D., Ph.D.,, Axel Glaessgen, M.D., Ph.D.,, Stefan Carlsson, M.D., Ph.D.,, Henrik Grnberg, M.D., Ph.D.,, and Tobias Nordstrm, M.D., Ph.D.

Issue&Volume: 2021-07-09

Abstract:

Background

High rates of overdiagnosis are a critical barrier to organized prostate cancer screening. Magnetic resonance imaging (MRI) with targeted biopsy has shown the potential to address this challenge, but the implications of its use in the context of organized prostate cancer screening are unknown.

Methods

We conducted a population-based noninferiority trial of prostate cancer screening in which men 50 to 74 years of age from the general population were invited by mail to participate; participants with prostate-specific antigen (PSA) levels of 3 ng per milliliter or higher were randomly assigned, in a 2:3 ratio, to undergo a standard biopsy (standard biopsy group) or to undergo MRI, with targeted and standard biopsy if the MRI results suggested prostate cancer (experimental biopsy group). The primary outcome was the proportion of men in the intention-to-treat population in whom clinically significant cancer (Gleason score ≥7) was diagnosed. A key secondary outcome was the detection of clinically insignificant cancers (Gleason score 6).

Results

Of 12,750 men enrolled, 1532 had PSA levels of 3 ng per milliliter or higher and were randomly assigned to undergo biopsy: 603 were assigned to the standard biopsy group and 929 to the experimental biopsy group. In the intention-to-treat analysis, clinically significant cancer was diagnosed in 192 men (21%) in the experimental biopsy group, as compared with 106 men (18%) in the standard biopsy group (difference, 3 percentage points; 95% confidence interval [CI], 1 to 7; P<0.001 for noninferiority). The percentage of clinically insignificant cancers was lower in the experimental biopsy group than in the standard biopsy group (4% [41 participants] vs. 12% [73 participants]; difference, 8 percentage points; 95% CI, 11 to 5).

Conclusions

MRI with targeted and standard biopsy in men with MRI results suggestive of prostate cancer was noninferior to standard biopsy for detecting clinically significant prostate cancer in a population-based screening-by-invitation trial and resulted in less detection of clinically insignificant cancer.

DOI: 10.1056/NEJMoa2100852

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2100852