title: MAPPED study design: a 6 month randomised controlled study to evaluate the effect of dutasteride on prostate cancer volume using magnetic resonance imaging.
abstract: OBJECTIVE
  To evaluate the percentage change in volume of prostate cancer, as assessed by T2-weighted MRI, following exposure to dutasteride (Avodart) 0.5mg daily for six months.
  
  
  METHODS
  MRI in Primary Prostate cancer after Exposure to Dutasteride (MAPPED) is a double-blind, placebo-controlled trial, supported by GlaxoSmithKline (GSK). Men with prostate cancer suitable for active surveillance (low-intermediate risk prostate cancer on biopsy), and a visible lesion on T2-weighted MRI of at least 0.2 cc, were eligible for consideration. Forty-two men were randomised to 6 months of daily dutasteride 0.5mg or placebo. Multi-parametric MRI (mpMRI) scans were performed at baseline, 3 and 6 months. The percentage changes in cancer volume over time will be compared between the dutasteride and placebo groups. Planned analyses will examine the association between tumour volume and characteristics (perfusion and contrast washout) as seen on mpMRI, HistoScan ultrasound and biopsy histopathology in both groups.
  
  
  CONCLUSIONS
  MAPPED is the first randomised controlled trial to use mpMRI to look at the effect of dutasteride on the volume of prostate cancer. If dutasteride is shown to reduce the volume of prostate cancer, it might be considered as an adjunct for men on active surveillance. Analysis of the placebo arm will allow us to comment on the short-term natural variability of the MR appearance in men who are not receiving any treatment.
  
  
  CONCLUSIONS
  MAPPED will evaluate the short-term effect of dutasteride on prostate cancer volume, as assessed by mpMRI, in men undergoing active surveillance for low or intermediate risk prostate cancer. The study completed recruitment in January 2012.
authors.affiliation: Division of Surgical & Interventional Science, University College London, UK. nicola.robertson7@nhs.net
authors.forename: N L
authors.initials: NL
authors.lastname: Robertson
authors.forename: C M
authors.initials: CM
authors.lastname: Moore
authors.forename: G
authors.initials: G
authors.lastname: Ambler
authors.forename: S R J
authors.initials: SR
authors.lastname: Bott
authors.forename: A
authors.initials: A
authors.lastname: Freeman
authors.forename: G
authors.initials: G
authors.lastname: Gambarota
authors.forename: C
authors.initials: C
authors.lastname: Jameson
authors.forename: A V
authors.initials: AV
authors.lastname: Mitra
authors.forename: B
authors.initials: B
authors.lastname: Whitcher
authors.forename: M
authors.initials: M
authors.lastname: Winkler
authors.forename: A
authors.initials: A
authors.lastname: Kirkham
authors.forename: C
authors.initials: C
authors.lastname: Allen
authors.forename: M
authors.initials: M
authors.lastname: Emberton
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000008:administration & dosage; D000328:Adult; D001378:Azasteroids / Q000008:administration & dosage*; D001706:Biopsy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000068538:Dutasteride; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D009929:Organ Size; D011446:Prospective Studies; D011467:Prostate / Q000473:pathology*; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D058891:5-alpha Reductase Inhibitors; D001378:Azasteroids; D000068538:Dutasteride