MRI-targeted or standard biopsy for prostate-cancer diagnosis

Veeru Kasivisvanathan, Antti S. Rannikko, Marcelo Borghi, Valeria Panebianco, Lance A. Mynderse, Markku H. Vaarala, Alberto Briganti, Lars Budäus, Giles Hellawell, Richard G. Hindley, Monique J. Roobol, Scott Eggener, Maneesh Ghei, Arnauld Villers, Franck Bladou, Geert M. Villeirs, Jaspal Virdi, Silvan Boxler, Grégoire Robert, Paras B. SinghWulphert Venderink, Boris A. Hadaschik, Alain Ruffion, Jim C. Hu, Daniel Margolis, Sébastien Crouzet, Laurence Klotz, Samir S. Taneja, Peter Pinto, Inderbir Gill, Clare Allen, Francesco Giganti, Alex Freeman, Stephen Morris, Shonit Punwani, Norman R. Williams, Chris Brew-graves, Jonathan Deeks, Yemisi Takwoingi, Mark Emberton, Caroline M. Moore, Anu Kenttämies, Tuomas Mirtti, Edgardo F. Becher, Carlo Catalano, Marcello Grompone, Maurizio Del Monte, Leonardo Costantino, Alessandro Sciarra, Giuseppe D'Eramo, Vincenzo Salvo, Riccardo Campa, Bernard F. King, Adam T. Froemming, Robert H. McLaren, Pamela J. Draayer, Jane E. Smith, Kathryn J. Doty, Panu Tonttila, Ville Virta, Mari Kuisma, Eija Pääkkö, Pasi Hirvikoski, Francesco Montorsi, Armando Stabile, Francesco De Cobelli, Antonio Esposito, Marta Picozzi, Giulia Cristel, Giorgio Brembilla, Michelle Hung, Frelyn Ocampo, Marjorie Otieno, Navin Ramachandran, Doug Pendse, Alex Kirkham, Charles Jameson, Marzena Ratynska, Imen Ben-Salha, Sami Ramzi Leyh-Bannurah, Dirk Beyersdorff, Guido Sauter, Anthony Chambers, Byiravey Pathmanathan, Wade Gayed, Eirini Vrentzou, Rachel Baldwin, Govinder Rajkumar, Amr Emara, Tim Nedas, Abigail Edwards, Chris H. Bangma, Martijn B. Busstra, Ivo G. Schoots, Aytekin Oto, Glenn Gerber, Taimur Shah, Sami Hamid, Paul Erotocritou, Barry Maraj, Jeevan Kumaradeevan, Philippe Puech, Jonathan Olivier, Oleg Loutochin, Pieter De Visschere, Nicolaas Lumen, Marleen Praet, Manit Arya, Harriet Thoeny, Clément Michiels, Yann Lebras, Gillian Smith, Lee Grant, Antony Goode, Soha El Sheikh, Jurgen J. Fütterer, J. P.Michiel Sedelaar, Jan P. Radtke, Markus Hohenfellner, David Bonekamp, Heinz Peter Schlemmer, Olivier Rouvière, Patrick Magill, David Elkin, Fatima Jichi, Richard Simon, Samim Patel, Ingrid Potyka, Neil McCartan, Cinzia Baldini, Jack Grierson, Aiman Haider, Christien Caris, Joke van Egmond, Wim Witjes, Peter Mulders, Anders Bjartell

Research output: Contribution to journalArticle

659 Scopus citations

Abstract

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.)

Original languageEnglish (US)
Pages (from-to)1767-1777
Number of pages11
JournalNew England Journal of Medicine
Volume378
Issue number19
DOIs
StatePublished - May 10 2018

ASJC Scopus subject areas

  • Medicine(all)

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    Kasivisvanathan, V., Rannikko, A. S., Borghi, M., Panebianco, V., Mynderse, L. A., Vaarala, M. H., Briganti, A., Budäus, L., Hellawell, G., Hindley, R. G., Roobol, M. J., Eggener, S., Ghei, M., Villers, A., Bladou, F., Villeirs, G. M., Virdi, J., Boxler, S., Robert, G., ... Bjartell, A. (2018). MRI-targeted or standard biopsy for prostate-cancer diagnosis. New England Journal of Medicine, 378(19), 1767-1777. https://doi.org/10.1056/NEJMoa1801993