Monique J. Roobol. Active Surveillance: update on Initiatives

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1 Monique J. Roobol Associate professor Dept. of Urology Erasmus University Medical Center Rotterdam, the Netherlands Active Surveillance: update on Initiatives

2 Overview Studies on Active Surveillance world wide PRIAS Movember GAP-3

3 Years

4 AS studies worldwide In total, 10 publications were included of which 5 originated from North America, 4 were European, and 1 was Australian The 10 papers included 3,550 patients and had an average median follow up of 4.5 years (range ).

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6 >= 4+3 is progression

7 Conclusions AS seems to be able to reduce over treatment of low risk and selected intermediate risk Pca Current tools for selection of candidates and monitoring of the disease process are inadequate and imprecise. Imaging and development of new markers hold potential needs to be tested in well conducted prospective trials.

8 htpps:// Participating countries

9 PRIAS htpps:// Criteria for inclusion in PRIAS: 1. Histologically proven adenocarcinoma of the prostate 2. Men should be fit for curative treatment 3. PSA-level at diagnosis 10 ng/ml 4. PSA density (PSA D) less than 0,2 5. Clinical stage T1C or T2 6. Adequate biopsy sampling (see 'biopsy protocol') 7. Gleason score 3+3=6 ( GS 7 in men > 70 yrs) 8. One or 2 biopsy cores invaded with prostate cancer (10% in saturation biopsy) 9. Participants must be willing to attend the follow-up visits

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11 Inclusions over time

12 Overall Age (median) 65,7 PSA (median) 5,6 Prostate volume 44,3 (median) PSA density 0,128 (median) ct-stage (n, %) T (86,5) T2 498 (13,4) Cores positive (n,%) (69) (31) Total 3701 (100) One year repeat biopsy Gleason (n, %) Cores positive (n, %) Overall No cancer 856 (37,4) (49,8) >=7 291 (12,7) (37,4) (25,9) (17,2) >=3 446 (19,5) Total 2287 (100)

13 Improving active surveillance Problem: random biopsies underestimate true Gleason score MRI targeted biopsies could improve pathologic grading

14 PRIAS MRI side study, Follow-up criteria

15 Movember Global Action plans Movember s vision is to have an everlasting impact on the state of men s health. The Movember Global Action Plan (GAP) aims to accelerate prostate cancer outcomes through global research collaboration.

16 Joining forces Movember GAP-3 Global Action Plan 3 The Movember GAP-3 on Active Surveillance (AS) of PC includes the integrated 30 months activity of 14 areas in the 5 Movember regions (Australasia, Europe, UK, Canada, USA) Construct a sustainable worldwide database for clinical, markerrelated, and imaging data for scientific analyses and improvement of guidelines on AS.

17 AIMS Creating a global consensus on selection and monitoring of men with low risk cancer; Managing a worldwide platform with information and guidelines on AS as an acknowledged treatment option for PC Reduction of number of men switching towards active therapy within one year after start of the AS protocol. Milestones Global AS database for clinical, bio specimen, imaging and biomarker data, including a virtual bio bank. Worldwide uniform tailor made guidelines on AS and a web-based platform on AS.

18 GAP-3 centers USA-Hopkins USA-MSKCC,NY USA-UCSF Canada-Toronto Canada-Vancouver UK-London (RMH/UCLH) UK-Cambridge Europe-Rotterdam Europe-Lille Europe-Helsinki Europe-Milan (PRIAS/SAINT) Australasia-Sydney/Melbourne Australasia-Kagawa Candidate centers USA-Washington University School of Medicine USA-Columbia University Medical Center, NY USA-Weill Cornell Medical College, NY USA-Winship Cancer Institute, Atlanta Canada-Montreal Canada-Calgary UK- Kings College Londen Europe- St. James s Hospital, Dublin Australasia-Sansom Institute,Adelaide

19 Our plan... Feb 2014-Aug 2016 Phase I (m1-12): 1. Construction of the global AS database, including a virtual bio bank on various available bio specimen. 2. Definition of database eligibility criteria for connecting eligible candidate centres to the global AS database. 3. AS consensus statement on currently available data Phase 2 (m13-30): 4.Connection of local databases of candidate centres to the global AS database (m13-30). 5.Statistical analysis of the database to address series of clinical questions (m13-30) 6.Development of the worldwide uniform tailor made guidelines on AS and a web-based platform on AS (m24-30). 7.Two demonstrations projects: integrating clinical data with genomic and imaging data

20 First meeting Amsterdam February 2014 Discussed contents of database Analysed results of 2 online surveys on AS criteria to form the basis of a consensus statement on AS based on currently available evidence.

21 We will keep you posted! Thank you