1. The Effect of Dutasteride on Magnetic Resonance Imaging Defined Prostate Cancer: MAPPED-A Randomized, Placebo Controlled, Double-Blind Clinical Trial
- Author
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Adebiyi Damola, Mathias Winkler, Manit Arya, Mark Emberton, Nicola L. Robertson, Hashim U. Ahmed, Gareth Ambler, Charles Jameson, Ramiro Castro, Fatima Jichi, Ashley J Ridout, Caroline M. Moore, Simon Bott, Neil McCartan, Clare Allen, Alex Kirkham, Anita Mitra, Francesco Giganti, Alex Freeman, Brandon Whitcher, Giulio Gambarota, Division of Surgery and Interventional Science [London, UK], University College of London [London] (UCL), Department of Urology [London, UK] ( King's College Hospital NHS Foundation Trust), King's College Hospital (KCH)-University College of London [London] (UCL), Biostatistics Group [London, UK], University College of London [London] (UCL)-University College London Hospitals (UCLH)-University College London Research Support Centre [UK], Department of Radiology [London, UK], University College London Hospitals (UCLH), Department of Urology [Surrey, UK], Frimley Park Hospital [Surrey, UK], Department of Urology [London, UK] (Charing Cross Hospital), Imperial College NHS Trust [London, UK] -Charing Cross Hospital [London, UK], Department of Clinical Oncology [London, UK], Department of Pathology [London, UK], GlaxoSmithKline Research and Development [Philadelphia, USA], Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Mathematics [Imperial College London], Imperial College London, Klarismo [London, UK], University College of London [London] (UCL)-University College London Hospitals (UCLH), Imperial College London-Charing Cross Hospital [London, UK], Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Jonchère, Laurent
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Male ,[SDV.IB.IMA]Life Sciences [q-bio]/Bioengineering/Imaging ,Biopsy ,030232 urology & nephrology ,Placebo-controlled study ,[SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology ,chemistry.chemical_compound ,Prostate cancer ,0302 clinical medicine ,5-alpha Reductase Inhibitors ,TARGETED BIOPSY ,RISK ,dutasteride ,medicine.diagnostic_test ,INHIBITOR ,Urology & Nephrology ,Middle Aged ,Magnetic Resonance Imaging ,3. Good health ,Tumor Burden ,Prostate-specific antigen ,030220 oncology & carcinogenesis ,[SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology ,Life Sciences & Biomedicine ,MRI ,Adult ,medicine.medical_specialty ,Urology ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,Placebo ,03 medical and health sciences ,[SDV.CAN] Life Sciences [q-bio]/Cancer ,Double-Blind Method ,Lower urinary tract symptoms ,medicine ,Humans ,Aged ,watchful waiting ,Gynecology ,Science & Technology ,business.industry ,Prostatic Neoplasms ,Magnetic resonance imaging ,1103 Clinical Sciences ,medicine.disease ,Dutasteride ,[SDV.MHEP.UN] Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology ,ACTIVE SURVEILLANCE ,Clinical trial ,[SDV.IB.IMA] Life Sciences [q-bio]/Bioengineering/Imaging ,chemistry ,VOLUME ,[SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology ,business - Abstract
International audience; 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
- Published
- 2017
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