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.

Patients and 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.

Discussion: 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.

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.