MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis

被引：2251

作者：

Kasivisvanathan, V ^{[1
,2
]}

Rannikko, A. S. ^{[11
,12
]}

Borghi, M. ^{[15
]}

Panebianco, V ^{[16
]}

Mynderse, L. A. ^{[19
]}

Vaarala, M. H. ^{[13
,14
]}

Briganti, A. ^{[17
,18
]}

Budaus, L. ^{[20
]}

Hellawell, G. ^{[3
]}

Hindley, R. G. ^{[7
]}

Roobol, M. J. ^{[23
]}

Eggener, S. ^{[25
]}

Ghei, M. ^{[4
]}

Villers, A. ^{[26
,27
]}

Bladou, F. ^{[32
]}

Villeirs, G. M. ^{[34
]}

Virdi, J. ^{[8
]}

Boxler, S. ^{[35
]}

Robert, G. ^{[28
,29
]}

Singh, P. B. ^{[5
]}

Venderink, W. ^{[24
]}

Hadaschik, B. A. ^{[21
,22
]}

Ruffion, A. ^{[30
]}

Hu, J. C. ^{[36
]}

Margolis, D. ^{[36
]}

Crouzet, S. ^{[31
]}

Klotz, L. ^{[33
]}

Taneja, S. S. ^{[37
]}

Pinto, P. ^{[38
]}

Gill, I ^{[39
]}

Allen, C. ^{[1
,2
]}

Giganti, F. ^{[1
,2
]}

Freeman, A. ^{[1
,2
]}

Morris, S. ^{[1
,2
]}

Punwani, S. ^{[1
,2
]}

Williams, N. R. ^{[6
]}

Brew-Graves, C. ^{[6
]}

Deeks, J. ^{[9
,10
]}

Takwoingi, Y. ^{[9
,10
]}

Emberton, M. ^{[1
,2
]}

Moore, C. M. ^{[1
,2
]}

机构：

[1] UCL, London, England

[2] UCL Hosp NHS Fdn Trust, London, England

[3] London North West Healthcare NHS Trust, London, England

[4] Whittington Hlth NHS Trust, London, England

[5] Royal Free London NHS Fdn Trust, London, England

[6] UCL Surg & Intervent Trials Unit, London, England

[7] Hampshire Hosp NHS Fdn Trust, Basingstoke, Hants, England

[8] Princess Alexandra Hosp NHS Trust, Harlow, Essex, England

[9] Univ Birmingham, Inst Appl Hlth Res, Birmingham, W Midlands, England

[10] Univ Birmingham, NIHR Birmingham Biomed Res Ctr, Birmingham, W Midlands, England

[11] Univ Helsinki, Helsinki, Finland

[12] Helsinki Univ Hosp, Helsinki, Finland

[13] Univ Oulu, Med Res Ctr Oulu, Oulu, Finland

[14] Oulu Univ Hosp, Oulu, Finland

[15] Ctr Urol, Buenos Aires, DF, Argentina

[16] Sapienza Univ, Rome, Italy

[17] Osped San Raffaele, IRCCS, Milan, Italy

[18] Univ Vita Salute San Raffaele, Milan, Italy

[19] Mayo Clin, Rochester, MN USA

[20] Martini Klin, Hamburg, Germany

[21] Univ Hosp Essen, Essen, Germany

[22] Univ Hosp Heidelberg, Heidelberg, Germany

[23] Erasmus Univ, Med Ctr, Rotterdam, Netherlands

[24] Radboud Univ Nijmegen, Med Ctr, Nijmegen, Netherlands

[25] Univ Chicago, Chicago, IL 60637 USA

[26] Univ Lille, Lille, France

[27] CHU Lille, Lille, France

[28] Univ Bordeaux, Bordeaux, France

[29] Bordeaux Pellegrin Univ Hosp, Bordeaux, France

[30] Hosp Civils Lyon, Ctr Hosp Lyon Sud, Lyon, France

[31] Hop Edouard Herriot, Hosp Civils Lyon, Lyon, France

[32] Jewish Gen Hosp, Montreal, PQ, Canada

[33] Sunnybrook Hlth Sci Ctr, Toronto, ON, Canada

[34] Ghent Univ Hosp, Ghent, Belgium

[35] Univ Hosp Bern, Bern, Switzerland

[36] Weill Cornell Med, New York Presbyterian Hosp, New York, NY USA

[37] NYU, Langone Med Ctr, New York, NY 10016 USA

[38] NIH, Bldg 10, Bethesda, MD 20892 USA

[39] Univ Southern Calif, Keck Sch Med, Inst Urol, Los Angeles, CA 90033 USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2018年 / 378卷 / 19期

基金：

美国国家卫生研究院;

关键词：

ULTRASOUND-GUIDED BIOPSY; MAGNETIC-RESONANCE; ACTIVE SURVEILLANCE; COST-EFFECTIVENESS; MEN; OUTCOMES; FUSION;

D O I：

10.1056/NEJMoa1801993

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1767 / 1777

页数：11

共 31 条

[1] Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study [J].