title: The PICTURE study -- prostate imaging (multi-parametric MRI and Prostate HistoScanning™) compared to transperineal ultrasound guided biopsy for significant prostate cancer risk evaluation.
abstract: OBJECTIVE
  The primary objective of the PICTURE study is to assess the negative predictive value of multi-parametric MRI (mp-MRI) and Prostate HistoScanning™ (PHS) in ruling-out clinically significant prostate cancer.
  
  
  METHODS
  PICTURE is a prospective diagnostic validating cohort study conforming to level 1 evidence. PICTURE will assess the diagnostic performance of multi-parametric Magnetic Resonance Imaging (mp-MRI) and Prostate HistoScanning™ (PHS) ultrasound. PICTURE will involve validating both index tests against a reference test, transperineal Template Prostate Mapping (TPM) biopsies, which can be applied in all men under evaluation. Men will be blinded to the index test results and both index tests will be reported prospectively prior to the biopsies being taken to ensure reporter blinding. Paired analysis of each of the index tests to the reference test will be done at patient level. Those men with an imaging lesion will undergo targeted biopsies to assess the clinical utility of sampling only suspicious areas. The study is powered to assess the negative predictive value of these imaging modalities in ruling-out clinically significant prostate cancer.
  
  
  CONCLUSIONS
  The PICTURE study aims to assess the performance characteristics of two imaging modalities (mp-MRI and Prostate HistoScanning) for their utility in the prostate cancer pathway. PICTURE aims to identify if either imaging test may be useful for ruling out clinically significant disease in men under investigation, and also to examine if either imaging modality is useful for the detection of disease. Recruitment is underway and expected to complete in 2014.
authors.affiliation: Division of Surgery and Interventional Science, University College London, UK. Electronic address: l.simmons1@nhs.net.
authors.forename: Lucy A M
authors.initials: LA
authors.lastname: Simmons
authors.affiliation: Division of Surgery and Interventional Science, University College London, UK.
authors.forename: Hashim Uddin
authors.initials: HU
authors.lastname: Ahmed
authors.affiliation: Division of Surgery and Interventional Science, University College London, UK.
authors.forename: Caroline M
authors.initials: CM
authors.lastname: Moore
authors.affiliation: Department of Radiology, University College London Hospitals, UK.
authors.forename: Shonit
authors.initials: S
authors.lastname: Punwani
authors.affiliation: Department of Pathology, University College London Hospitals, UK.
authors.forename: Alex
authors.initials: A
authors.lastname: Freeman
authors.affiliation: Centre for Medical Imaging and Computing, University College London, UK.
authors.forename: Yipeng
authors.initials: Y
authors.lastname: Hu
authors.affiliation: Centre for Medical Imaging and Computing, University College London, UK.
authors.forename: Dean
authors.initials: D
authors.lastname: Barratt
authors.affiliation: London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Susan C
authors.initials: SC
authors.lastname: Charman
authors.affiliation: London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Jan
authors.initials: J
authors.lastname: Van der Meulen
authors.affiliation: Division of Surgery and Interventional Science, University College London, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Emberton
mesh_terms: D002277:Carcinoma / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000473:pathology; D015331:Cohort Studies; D006801:Humans; D061705:Image-Guided Biopsy; D008279:Magnetic Resonance Imaging; D008297:Male; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011467:Prostate / Q000000981:diagnostic imaging / Q000473:pathology*; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000473:pathology; D014463:Ultrasonography
keywords: Imaging; MRI; NPV; PHS; PSA; Prostate HistoScanning; Prostate cancer; TPM; TRUS biopsy; Transperineal Template Prostate Mapping biopsies; Trial design; mp-MRI; multi-parametric Magnetic Resonance Imaging; negative predictive value; prostate specific antigen; transperineal Template Prostate Mapping; transrectal ultrasound guided biopsy