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Clinical Audit Report. Review of the Prostate Cancer detection rate in men undergoing MRI and TRUS biopsy Project number 2012. Surgery / Urology. Ahmed Ibrahim Mr Iqbal Miakhil (Clinical Audit Lead). Project start date: 01/06/2018 Project end date: 31/07/2018.
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Clinical Audit Report Review of the Prostate Cancer detection rate in men undergoing MRI and TRUS biopsyProject number 2012 Surgery / Urology Ahmed Ibrahim Mr Iqbal Miakhil (Clinical Audit Lead) Project start date: 01/06/2018 Project end date: 31/07/2018 Name of Meeting and Presentation Date RHD 28th November 2018
Background • MP- MRI incorporates the combined use of anatomic and functional pulse sequences. Anatomic pulse sequences include T1 and T2- weighted images. Functional pulse sequences include diffusion weighted DW MRI and dynamic contrast enhanced MRI. • DCE-MRI evaluates the vascularity of the prostate in order to identify permeability changes related to tumor angiogenesis. • prostate mpMRI is increasingly used in patients with a suspicion of PCa to localize abnormal areas before biopsy. • A large body of literature has shown that targeted biopsies of suspicious lesions seen on mpMRI (TBx) improved the detection of clinically significant PCa (csPCa) • MP-MRI has a positive predictive value of 85% for prostate cancer for index lesions when the Prostate Imaging Reporting and Data System (PIRADS) is 3 or above. • there is a significant problem with subjective and inconsistent interpretation of lesions and with false-positive results, particularly in the transition zone.
Project’s aims and objectives • This study aims to determine the accuracy of prebiopsy mpMRI in detecting clinically significant prostate cancer in the subsequent TRUS biopsy and its efficacy in excluding unnecessary biopsies. • Whether MP- MRI improves the detection of clinically significant prostate cancer and avoids the need for systematic biopsy in biopsy-naive patients remains controversial. • Prebiopsy MRI scan is a common practise currently, However Both NICE and EAU guidelines did not endorse such practice yet . • Previous Audit 1248 looked at the correlation between MRI and Trans rectal ultrasound and biopsy of the prostate • This Audit looked only at those patients with PIRADS 3 Prostate cancer • With regard to using Mp MRI as a tool for diagnosing Prostate Cancer, this audit showed a sensitivity of 82.61%, and a Specificity of 73.68%
Audit standard(s) • This slide is not applicable to surveys • Define what criteria you will be measuring the current practice against • Source of your criteria (NICE Guidance, Royal College, DoH, …) • Credibility and evidence base • The content needs to be consistent with the project outcome table (slide 6)
Methodology • Sample size • A total of 460 men with a mean age of 65 years had prebiopsy MP-MRI scans , of which 250 (54.3%) scans were reported as PIRADS 3 or above (PIRADS 3= 76, PIRADS 4=83 and PIRADS 5=91). 210 (45.7%) scans were reported as negative (PIRADS 1 AND 2) . • Out of the 460 patients, histology confirmed 224 (48.67%) patients had prostate cancer of any grade, and 136 (29.6%) of these had clinically significant prostate cancer defined as Gleason 7 or greater. • Data collection • Scope of the project • One or multiple sites, one or multiple clinicians, one or multiple data collectors • Time scale (project ends at the presentation and formulation of an action plan) • Method used in collecting the data • Prospective or Retrospective • Information of the method used • Clinical notes, databases used, questionnaires, interviews, observation
Data collection pro-forma Data Collection Tool saved in the project folder
Key Findings • The sensitivity of PIRADS 3 or above at detecting any prostate cancer is 77.2% and the positive predictive value is 69.2%. • The specificity of the MRI scan with a cut off of PIRADS 3 or above is 67.4% and the negative predictive value of below PIRADS 3 is 75.7%.
Project outcome • Please amend and use the following example table to summarise your results (reflecting audit standards table as in slide 5) • Variance only applicable when you have 2 cycles • Please state whether your overall assessment of outcome is either compliant, partial compliant or non-compliant
Recommendations • The findings from this audit have been communicated to the wider Urology department and shared with our colleagues at Addenbrookes SMDT • Further Audit is not required – the questions asked by this Audit have been satisfactorily answered
Actions to be taken Actions need to be agreed by all the groups affected and an individual named to take each action forward and ensure it is completed. An estimated time for completion will assist in knowing when to check and when to schedule the remedial cycle of the audit.