Moore, CM;
Robertson, NL;
Jichi, F;
Damola, A;
Ambler, G;
Giganti, F;
Ridout, AJ;
... Emberton, M; + view all
(2017)
The effect of dutasteride on MRI-defined prostate cancer lesions: MAPPED (Magnetic resonance imaging in Primary Prostate Cancer after Exposure to Dutasteride) - a randomized placebo-controlled, double-blind clinical trial.
The Journal of Urology
, 197
(4)
pp. 1006-1013.
10.1016/j.juro.2016.11.090.
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Abstract
PURPOSE: Dutasteride is licensed for symptomatic benign prostatic hyperplasia, and has been associated with a lower progression rate in low-risk prostate cancer. We have evaluated the effect of dutasteride on prostate cancer volume as assessed by T2-weighted Magnetic Resonance Imaging (MRI). 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 an MR visible lesion of >/= 0.2ml on T2-weighted sequences were randomized to daily dutasteride 0.5mg or placebo for 6 months. Lesion volume was assessed at baseline, 3 and 6 months, with an image-guided biopsy to the lesion at study exit. The primary endpoint was percentage reduction in lesion volume over 6 months. This trial was registered with the European Clinical Trials register (EudraCT 2009-102405-18). RESULTS: Forty-two men were recruited between June 2010 and January 2012. In the dutasteride group, the average volumes at baseline and 6 months were 0.55ml and 0.38ml respectively, and the average percentage reduction was 36%. In the placebo group, the average volumes at baseline and 6 months were 0.65ml and 0.76ml respectively, and the average percentage reduction was -12%. The difference in percentage reductions between groups was 48% (95% CI 27.4-68.3%. p< 0.0001). The most common adverse event was deterioration in erectile function (25% in men randomized to dutasteride, 16% in men randomized to placebo). CONCLUSIONS: Dutasteride was associated with a significant reduction in prostate cancer volume on T2 weighted MRI images compared to placebo.
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