Best Practice Pathway for Prostate Cancer

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1 Best Practice Pathway for Prostate Cancer Hashim Ahmed Professor and Chair of Urology Consultant Urological Surgeon Division of Surgery, Imperial College London Department of Urology, Imperial College Healthcare NHS Trust Clinical Lead, RM Partners RAPID Programme Chair, NHS England Prostate Clinical Expert Group Chair, NCRI Prostate Clinical Studies Group

2 Total Number of Cases Diagnosed Prostate cancer is a growing health burden 100,000 50, Time, years

3 The errors that result from the current pathway... Clinically indolent cancers are identified by chance Clinically significant lesions are missed Important cancers are incorrectly classified as unimportant Men undergo whole-gland treatment which carries harm

4 A strategy to overcome the errors in the current pathway Not all lesions have the potential to progress to invasive and metastatic cancer Imaging and precision biopsy can identify those lesions that are likely to progress Prostate lumpectomy can reduce treatment related harms

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6 PROMIS: Prostate MRI Imaging Study PROMIS is funded by the UK Government Department of Health, National Institute of Health Research Health Technology Assessment Programme, (Project number 09/22/67). UK Department of Health Disclaimer: The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the health technology assessment program, NIHR, NHS or the Department of Health.

7 MP-MRI triage compared to Transrectal biopsy Test attribute Transrectal biopsy MP-MRI Odds ratio* [95% CI] p-value Sensitivity 48% 93% 0.06 [ ] Specificity 96% 41% 0.02 [ ] PPV 90% 51% 8.2 [ ] NPV 74% 89% 0.34 [ ] p< p< p< p<0.0001

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9 Courtesy of Veeru Kasivisvanathan

10 Can we justify no biopsy in non-suspicious mpmri?

11 We use tests that always miss some disease 6% to 46% of women with invasive cancer will have negative mammograms US National Cancer Institute

12 Reference Detection of Gleason 7 cancer on TRUS Biopsy when MP-MRI is Negative (adapted from Anwar Padhani table) Gleason >/=7 on TRUSbiopsy (in non-suspicious MRI) % Gleason 7 on TRUS biopsy (in nonsuspicious MRI) Itatani /193 10% Pokorny /81 11% Wysock /29 0% Wang /39 10% Lu /38 3% Washino /131 16% Sokhi (ECR 2018) 1/26 4% An JY /20 0% Porpiglia /16 4% PROMIS (Ahmed comm) 8/158 5%

13 Can we justify transperineal biopsy in all?

14 Biopsy related sepsis an avoidable harm N=198,361 ~2% sepsis Anastasiades et al, 2015

15 Transperineal biopsies under LA or sedation 1 in 500 sepsis

16 Do we need image-fusion?

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18 Do we need image-fusion tarhgeting? Smart Target and PICTURE trials Image Fusion and Cognitive Targeting have similar overall detection rates - Image fusion detects 10% of significant cancers that cognitive targeting misses - Cognitive targeting misses 10% of significant cancer that image-fusion misses We need both

19 We need to set national metrics of quality - Pre-biopsy mpmri - Non-suspicious mpmri - Biopsies in non-suspicious mpmri - Low-risk cancers diagnosed - Low-risk cancers treated (unnecessarily) - Significant cancers diagnosed when mpmri suspicious - Rates of repeat biopsies and re-referrals Hashim Ahmed

20 Impact of MRI pre-biopsy in Imperial Standard TRUS pathway Triage mp-mri Pathway p-value Biopsy 100% 59% 0.05 UCL/Ahmed definition 1 12% 24% 0.05 UCL/Ahmed definition 2 25% 33% 0.05 Any length of Gleason >/=3+4 23% 31% 0.05 Any length of Gleason >/=4+3 6% 16% 0.05 Insignificant cancer detection 12% 2% 0.05 Definition 1: Any length of Gleason >/=4+3 or >/=6mm of Gleason 3+3 Definition 2: Any length of Gleason >/=3+4 or >/=4mm of Gleason 3+3

21 RM Partners / Imperial RAPID Programme NHS England Transformation Funded Lead: Ahmed HU. 2.8M ( ) 3 pilot sites (Imperial, St Georges, Epsom) Same day MRI and report, clinical review and IF NECESSARY, a targeted biopsy Transperineal NOT Transrectal biopsy Quality reviews at every stage

22 Current RAPID model Initial Imperial pilot results 99 patients 75% biopsied Average time from Referral to Diagnosis 22 days Average time from Referral to Treatment 40 days

23 Conclusions The standard approach to diagnosing prostate cancer is blind to location of cancer The standard approach to diagnosing prostate cancer leads to unnecessary harms Prostate MRI can allow at least one-third of men to avoid an unnecessary biopsy Prostate MRI can improve the detection of higher risk cancers and reduce detection of insignificant cancers There are challenges in delivery and dissemination