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MRI-targeted or standard biopsy for prostate-cancer diagnosis
Authors
Clare Allen
Franck Bladou
+31 more
Marcelo Borghi
Silvan Boxler
Alberto Briganti
Lars Budäus
Sébastien Crouzet
Scott Eggener
Alex Freeman
Maneesh Ghei
Francesco Giganti
Inderbir Gill
Boris A. Hadaschik
Giles Hellawell
Richard G. Hindley
Jim C. Hu
Veeru Kasivisvanathan
Laurence Klotz
Daniel Margolis
Lance A. Mynderse
Valeria Panebianco
Peter Pinto
Antti S. Rannikko
Grégoire Robert
Monique J. Roobol
Alain Ruffion
Paras B. Singh
Samir S. Taneja
Markku H. Vaarala
Wulphert Venderink
Geert M. Villeirs
Arnauld Villers
Jaspal Virdi
Publication date
10 May 2018
Publisher
Health Sciences Research Commons
Abstract
Copyright © 2018 Massachusetts Medical Society. 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\u3c0.001). 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.
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George Washington University: Health Sciences Research Commons (HSRC)
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Last time updated on 03/12/2020