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Contemporary Clinical Trials

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Presentation on theme: "Contemporary Clinical Trials"— Presentation transcript:

1 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 (May 2015) DOI: /j.cct Copyright © 2015 The Authors Terms and Conditions

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

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

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

5 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  , 26-40DOI: ( /j.cct ) Copyright © 2015 The Authors Terms and Conditions

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

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

8 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): Contemporary Clinical Trials  , 26-40DOI: ( /j.cct ) Copyright © 2015 The Authors Terms and Conditions

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


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