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The effect of dutasteride on magnetic resonance imaging defined prostate cancer: MAPPED-a randomized, placebo controlled, double-blind clinical trial

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Title: The effect of dutasteride on magnetic resonance imaging defined prostate cancer: MAPPED-a randomized, placebo controlled, double-blind clinical trial
Authors: Moore, CM
Robertson, NL
Jichi, F
Damola, A
Ambler, G
Giganti, F
Ridout, AJ
Bott, SRJ
Winkler, M
Ahmed, HU
Arya, M
Mitra, AV
McCartan, N
Freeman, A
Jameson, C
Castro, R
Gambarota, G
Whitcher, BJ
Allen, C
Kirkham, A
Emberton, M
Item Type: Journal Article
Abstract: Purpose Dutasteride, which is licensed for symptomatic benign prostatic hyperplasia, has been associated with a lower progression rate of low risk prostate cancer. We evaluated the effect of dutasteride on prostate cancer volume as assessed by T2-weighted magnetic resonance imaging. Materials and Methods In this randomized, double-blind, placebo controlled trial, men with biopsy proven, low-intermediate risk prostate cancer (up to Gleason 3 + 4 and PSA up to 15 ng/ml) who had visible lesion of 0.2 ml or greater on T2-weighted magnetic resonance imaging sequences were randomized to daily dutasteride 0.5 mg or placebo for 6 months. Lesion volume was assessed at baseline, and 3 and 6 months with image guided biopsy to the lesion at study exit. The primary end point was the percent reduction in lesion volume over 6 months. This trial was registered with the European Clinical Trials register (EudraCT 2009-102405-18). Results A total of 42 men were recruited between June 2010 and January 2012. In the dutasteride group, the average volumes at baseline and 6 months were 0.55 and 0.38 ml, respectively and the average reduction was 36%. In the placebo group, the average volumes at baseline and 6 months were 0.65 and 0.76 ml, respectively, and the average reduction was −12%. The difference in percent reductions between the groups was 48% (95% CI 27.4–68.3, p <0.0001). The most common adverse event was deterioration in erectile function, which was 25% in men randomized to dutasteride and 16% in men randomized to placebo. Conclusions Dutasteride was associated with a significant reduction in prostate cancer volume on T2-weighted magnetic resonance imaging compared to placebo.
Issue Date: 16-Nov-2016
Date of Acceptance: 14-Nov-2016
URI: http://hdl.handle.net/10044/1/54026
DOI: https://dx.doi.org/10.1016/j.juro.2016.11.090
ISSN: 0022-5347
Publisher: Elsevier
Start Page: 1006
End Page: 1013
Journal / Book Title: Journal of Urology, The
Volume: 197
Issue: 4
Copyright Statement: © 2017 by American Urological Association Education and Research, Inc. This manuscript is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/
Keywords: Science & Technology
Life Sciences & Biomedicine
Urology & Nephrology
prostatic neoplasms
watchful waiting
magnetic resonance imaging
biopsy
dutasteride
ACTIVE SURVEILLANCE
TARGETED BIOPSY
RISK
INHIBITOR
VOLUME
MRI
1103 Clinical Sciences
Publication Status: Published
Appears in Collections:Division of Surgery
Faculty of Medicine
Faculty of Natural Sciences



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