Contemporary Clinical Trials PROMIS — Prostate MR imaging study: A paired validating cohort study evaluating the role of multi-parametric MRI in men with clinical suspicion of prostate cancer  A. El-Shater Bosaily, C. Parker, L.C. Brown, R. Gabe, R.G. Hindley, R. Kaplan, M. Emberton, H.U. Ahmed  Contemporary Clinical Trials  Volume 42, Pages 26-40 (May 2015) DOI: 10.1016/j.cct.2015.02.008 Copyright © 2015 The Authors Terms and Conditions

Fig. 1 Over-detection of insignificant prostate cancer resulting from TRUS-guided biopsies. Contemporary Clinical Trials 2015 42, 26-40DOI: (10.1016/j.cct.2015.02.008) Copyright © 2015 The Authors Terms and Conditions

Fig. 2 Under-detection of clinically significant prostate cancer resulting from TRUS-guided biopsies. Contemporary Clinical Trials 2015 42, 26-40DOI: (10.1016/j.cct.2015.02.008) Copyright © 2015 The Authors Terms and Conditions

Fig. 3 Current and proposed diagnostic pathways should MP-MRI prove favourable. Contemporary Clinical Trials 2015 42, 26-40DOI: (10.1016/j.cct.2015.02.008) Copyright © 2015 The Authors Terms and Conditions

Fig. 4 PROMIS Trial Schema. N.B.: visit one (registration) includes a detailed discussion of the patient information sheet and what to expect from participation in PROMIS. Followed by signing an informed consent and assessment of patient's eligibility. Contemporary Clinical Trials 2015 42, 26-40DOI: (10.1016/j.cct.2015.02.008) Copyright © 2015 The Authors Terms and Conditions

Fig. 5 MP-MRI reporting form. Contemporary Clinical Trials 2015 42, 26-40DOI: (10.1016/j.cct.2015.02.008) Copyright © 2015 The Authors Terms and Conditions

Fig. 6 Illustration of how Transperineal Template Prostate Mapping biopsies are conducted. Contemporary Clinical Trials 2015 42, 26-40DOI: (10.1016/j.cct.2015.02.008) Copyright © 2015 The Authors Terms and Conditions

Fig. 7 Definitions of clinical significance on TTPM-biopsy. Red signifies UCL definition 1 against which the primary outcome will be validated. Yellow signifies UCL definition 2 and is a secondary outcome. From Ahmed HU et al., J Urol, 2011; 186(2):458-64. Contemporary Clinical Trials 2015 42, 26-40DOI: (10.1016/j.cct.2015.02.008) Copyright © 2015 The Authors Terms and Conditions

Fig. 8 Illustration summarizing some of the assumptions made in determining sample size calculations for the primary outcome. Contemporary Clinical Trials 2015 42, 26-40DOI: (10.1016/j.cct.2015.02.008) Copyright © 2015 The Authors Terms and Conditions