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

[11] New methods for modelling EQ-5D-5L value sets: An application to English data [J].

Feng, Yan ;

Devlin, Nancy J. ;

Shah, Koonal K. ;

Mulhern, Brendan ;

van Hout, Ben .

HEALTH ECONOMICS, 2018, 27 (01) :23-38

[12] Role of magnetic resonance imaging before initial biopsy: comparison of magnetic resonance imaging-targeted and systematic biopsy for significant prostate cancer detection [J].

Haffner, Jeremie ;

Lemaitre, Laurent ;

Puech, Philippe ;

Haber, Georges-Pascal ;

Leroy, Xavier ;

Jones, J. Stephen ;

Villers, Arnauld .

BJU INTERNATIONAL, 2011, 108 (8B) :E171-E178

[13] 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer [J].

Hamdy, F. C. ;

Donovan, J. L. ;

Lane, J. A. ;

Mason, M. ;

Metcalfe, C. ;

Holding, P. ;

Davis, M. ;

Peters, T. J. ;

Turner, E. L. ;

Martin, R. M. ;

Oxley, J. ;

Robinson, M. ;

Staffurth, J. ;

Walsh, E. ;

Bollina, P. ;

Catto, J. ;

Doble, A. ;

Doherty, A. ;

Gillatt, D. ;

Kockelbergh, R. ;

Kynaston, H. ;

Paul, A. ;

Powell, P. ;

Prescott, S. ;

Rosario, D. J. ;

Rowe, E. ;

Neal, D. E. .

NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (15) :1415-1424

[14] Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) [J].

Herdman, M. ;

Gudex, C. ;

Lloyd, A. ;

Janssen, M. F. ;

Kind, P. ;

Parkin, D. ;

Bonsel, G. ;

Badia, X. .

QUALITY OF LIFE RESEARCH, 2011, 20 (10) :1727-1736

[15] Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study [J].

Janssen, M. F. ;

Pickard, A. Simon ;

Golicki, Dominik ;

Gudex, Claire ;

Niewada, Maciej ;

Scalone, Luciana ;

Swinburn, Paul ;

Busschbach, Jan .

QUALITY OF LIFE RESEARCH, 2013, 22 (07) :1717-1727

[16] A multicentre randomised controlled trial assessing whether MRI-targeted biopsy is non-inferior to standard transrectal ultrasound guided biopsy for the diagnosis of clinically significant prostate cancer in men without prior biopsy: a study protocol [J].

Kasivisvanathan, Veeru ;

Jichi, Fatima ;

Klotz, Laurence ;

Villers, Arnauld ;

Taneja, Samir S. ;

Punwani, Shonit ;

Freeman, Alex ;

Emberton, Mark ;

Moore, Caroline M. .

BMJ OPEN, 2017, 7 (10)

[17] The PRECIS-2 tool: designing trials that are fit for purpose [J].

Loudon, Kirsty ;

Treweek, Shaun ;

Sullivan, Frank ;

Donnan, Peter ;

Thorpe, Kevin E. ;

Zwarenstein, Merrick .

BMJ-BRITISH MEDICAL JOURNAL, 2015, 350

[18] Contemporary Nationwide Patterns of Active Surveillance Use for Prostate Cancer [J].

Maurice, Matthew J. ;

Abouassaly, Robert ;

Kim, Simon P. ;

Zhu, Hui .

JAMA INTERNAL MEDICINE, 2015, 175 (09) :1569-1571

[19] Standards of Reporting for MRI-targeted Biopsy Studies (START) of the Prostate: Recommendations from an International Working Group [J].

Moore, Caroline M. ;

Kasivisvanathan, Veeru ;

Eggener, Scott ;

Emberton, Mark ;

Futterer, Jurgen J. ;

Gill, Inderbir S. ;

Grubb, Robert L., III ;

Hadaschik, Boris ;

Klotz, Laurence ;

Margolis, Daniel J. A. ;

Marks, Leonard S. ;

Melamed, Jonathan ;

Oto, Aytekin ;

Palmer, Suzanne L. ;

Pinto, Peter ;

Puech, Philippe ;

Punwani, Shonit ;

Rosenkrantz, Andrew B. ;

Schoots, Ivo G. ;

Simon, Richard ;

Taneja, Samir S. ;

Turkbey, Baris ;

Ukimura, Osamu ;

van der Meulen, Jan ;

Villers, Arnauld ;

Watanabe, Yuji .

EUROPEAN UROLOGY, 2013, 64 (04) :544-552

[20] Multiparameric magnetic resonance imaging vs. standard care in men being evaluated for prostate cancer: A randomized study [J].

Panebianco, Valeria ;

Barchetti, Flavio ;

Sciarra, Alessandro ;

Ciardi, Antonio ;

Indino, Elena Lucia ;

Papalia, Rocco ;

Gallucci, Michele ;

Tombolini, Vincenzo ;

Gentile, Vincenzo ;

Catalano, Carlo .

UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS, 2015, 33 (01) :17.e1-17.e7

← 1 2 3 4 →