今年刚发表在《新英格兰医学杂志》上的研究被称为前列腺癌重要临床的评估：是否使用图像引导取样？这一项目研究了500个对前列腺特异性抗原(PSA)水平升高和/或数字直肠检查结果异常(DRE)，怀疑为前列腺癌的患者。

结果表明，在MRI靶向活检组中，252名男性中有71人（28%）的MRI检查结果并没有提示前列腺癌，因此他们没有进行活检。在有针对性的活检组中，95名男性（38%）发现了临床上显著的癌症，而标准活检组中248人有64人（26%），（调整后差异：12个百分点；95%CI 4-20；P＝0.005）。MRI加或不加针对性的活检不比标准活检差。以95%CI看来，这种策略的优势超过标准的活检。MRI靶向活检组比标准活检组被诊断为临床非显著的癌症更少（调整后差异：−13个百分点；95% CI，−19−7；P＜0.001）。

“因此，在活检前和MRI靶向活检时使用MRI的风险评估或许优于以前的经直肠超声引导活检。” 该项目负责人英国伦敦大学学院的Veeru Kasivisvanathan, MD这样评价这项研究，“在第一次需要对前列腺癌进行筛查的男性中，PRECISION研究表明，使用核磁共振成像来鉴别前列腺中可疑的癌症，并对MRI信息进行前列腺活检，诊断出的癌症比我们过去25年进行前列腺活检的标准方法要多。”

原  文

BACKGROUND

Multiparametric magnetic resonance imaging (MRI), with or without targeted biopsy, is an alternative to standard transrectal ultrasonography–guided biopsy for prostate-cancer detection in men with a raised prostate-specific antigen level who have not undergone biopsy. However, comparative evidence is limited.

METHODS

In a multicenter, randomized, noninferiority trial, we assigned men with a clinical suspicion of prostate cancer who had not undergone biopsy previously to undergo MRI, with or without targeted biopsy, or standard transrectal ultrasonography–guided biopsy. Men in the MRI-targeted biopsy group underwent a targeted biopsy (without standard biopsy cores) if the MRI was suggestive of prostate cancer; men whose MRI results were not suggestive of prostate cancer were not offered biopsy. Standard biopsy was a 10-to-12–core, transrectal ultrasonography–guided biopsy. The primary outcome was the proportion of men who received a diagnosis of clinically significant cancer. Secondary outcomes included the proportion of men who received a diagnosis of clinically insignificant cancer.

Results:

A total of 500 men underwent randomization. In the MRI-targeted biopsy group, 71 of 252 men (28%) had MRI results that were not suggestive of prostate cancer, so they did not undergo biopsy. Clinically significant cancer was detected in 95 men (38%) in the MRI-targeted biopsy group, as compared with 64 of 248 (26%) in the standard-biopsy group (adjusted difference, 12 percentage points; 95% confidence interval [CI], 4 to 20; P=0.005). MRI, with or without targeted biopsy, was noninferior to standard biopsy, and the 95% confidence interval indicated the superiority of this strategy over standard biopsy. Fewer men in the MRI-targeted biopsy group than in the standard-biopsy group received a diagnosis of clinically insignificant cancer (adjusted difference, −13 percentage points; 95% CI, −19 to −7; P<0.001).

CONCLUSIONS

The use of risk assessment with MRI before biopsy and MRI-targeted biopsy was superior to standard transrectal ultrasonography–guided biopsy in men at clinical risk for prostate cancer who had not undergone biopsy previously. (Funded by the National Institute for Health Research and the European Association of Urology Research Foundation; PRECISION ClinicalTrials.gov number, NCT02380027.)