RADICALS-RT monthly accrual report (Sep-2014) Radiotherapy Timing Randomisation Summary points • 18 patients recruited to Radiotherapy Timing question this month • 897 patients recruited to Radiotherapy Timing question in total • 1250 patients aiming to be recruited by mid-2016 Radiotherapy Timing detail The first patient was randomised on 22-Nov-2007 The total number of patients randomised to RT timing randomisation for the month ending 30-Sep-2014 is: 897 patients out of a target of 1250 patients Table 1 - RADICALS-RT allocated treatment Variable Summary statistics Allocated treatment - RADICALS-RT 1 Early RT 451 (50%) Deferred RT 446 (50%) 1: n (column percentage) Patients allocated to Immediate RT can choose to participate in Hormone Duration randomisation - for the patients who decide to participate: Table 2 - RADICALS-HD allocated treatment Variable Summary statistics Allocated treatment - RADICALS-HD 1 RT alone 39 (29%) RT + 6 mths HT 64 (47%) RT + 2 yrs HT 33 (24%) 1: n (column percentage) Table 3 - Randomising country Variable Summary statistics Country 1 UK 745 (83%) Canada 32 (4%) Ireland 12 (1%) Denmark 108 (12%) 1: n (column percentage) Figure 1 - Monthly randomisations by country for the last 13 months Figure 2 - Observed vs expected RT timing randomisation - Full period Table 4 - Radiotherapy Timing randomisation for the last 3 months Rank Hospital Country Jul Aug Sep Total First patient Last patient 1 Rigshospitalet Uni Hosp Denmark 1 5 1 60 2011_08 2014_09 2 Herlev University Hospital Denmark 2 . 1 43 2011_10 2014_09 3 Wakefield, Pinderfields Gen Hosp UK 4 . 40 2009_01 2014_07 4 Bristol, Southmead Hosp UK . 2 . 33 2009_01 2014_08 5 Leeds, St James Uni Hosp UK . 1 30 2008_07 2014_09 6 Birmingham Heartlands Hosp UK 1 . 1 27 2010_03 2014_09 7 Newport, Royal Gwent Hosp UK . 1 26 2008_09 2014_09 8 Southampton General Hosp UK . 3 3 26 2011_05 2014_09 9 Herts, Mount Vernon Hosp UK . 1 23 2008_02 2014_09 10 Bradford Royal Inf UK . 21 2009_02 2014_06 11 Kent And Canterbury Hosp UK 1 . 1 20 2009_07 2014_09 12 Birmingham, Queen Elizabeth Hosp UK 1 . 20 2011_04 2014_07 13 Maidstone Hospital UK 1 1 . 19 2009_06 2014_08 14 York District Hosp UK . 1 18 2008_12 2014_09 15 London, Guy's Hosp UK . 17 2009_08 2013_08 16 Newcastle, Freeman Hosp UK . 15 2010_07 2014_06 17 Belfast City Hosp UK . 14 2009_11 2013_10 18 Manchester, Hope Hosp UK 1 . 13 2009_05 2014_07 19 Surrey, Royal Surrey County Hosp UK . 13 2009_01 2014_04 20 Cardiff, Uni Hosp of Wales UK 1 . 12 2008_09 2014_07 21 Romford, Queen's Hosp UK 1 . 12 2011_01 2014_07 22 Hull, Castle Hill Hosp UK . 12 2010_06 2014_06 23 Galway Uni College Hosp Ireland . 12 2011_06 2013_08 24 Bristol Haem & Onco Centre UK . 11 2009_11 2013_01 25 Wolverhampton, New Cross Hosp UK 1 3 1 10 2013_04 2014_09 26 Manchester, Christie Hosp UK . 10 2011_04 2014_05 27 Royal Devon and Exeter Hosp UK . 10 2010_11 2014_04 28 Coventry, Uni Hosp Coventry & Warwicks UK . 10 2008_12 2013_11 29 Southend Hosp UK . 10 2009_07 2013_11 30 Manchester, Stepping Hill Hosp UK . 10 2008_06 2013_10 31 London, St Bartholomews Hosp UK 1 . 9 2010_11 2014_07 32 London, Mayday Hosp UK . 9 2008_03 2014_06 33 Northampton Gen Hosp UK . 9 2010_05 2014_05 34 Nottingham Uni Hosp UK . 9 2009_01 2014_04 35 Somerset, Musgrove Park hosp UK . 9 2010_11 2013_12 36 Rhyl, Glan Clwyd UK . 9 2009_05 2013_11 37 Royal Blackburn Hosp UK . 9 2010_12 2012_10 38 London, Whipps Cross Uni Hosp UK . 1 . 8 2012_02 2014_08 39 Slough, Wexham Park Hosp UK . 8 2010_12 2013_07 40 Sherbrooke, Centre Hosp Uni Canada . 7 2011_06 2014_04 41 Royal Preston Hosp UK . 7 2011_01 2013_12 42 Worchestershire Royal Hosp UK . 7 2011_12 2013_08 43 Toronto, Princess Margaret Hosp Canada . 7 2008_07 2013_06 44 Cheltenham Gen Hosp UK . 7 2011_08 2013_02 45 Wirral, Clatterbridge Centre For Onc UK . 7 2010_03 2012_10 46 Crewe, Leighton Hosp UK . 1 6 2010_12 2014_09 47 Royal Shrewsbury Hosp UK . 3 6 2012_07 2014_09 48 Sutton, Royal Marsden Hosp UK . 2 . 6 2007_11 2014_08 49 Doncaster Royal Inf UK 1 . 6 2011_06 2014_07 50 Leicester Royal Infirmary UK 1 . 6 2013_01 2014_07 51 Portsmouth, Queen Alexandra Hosp UK 2 . 6 2010_03 2014_07 52 Poole Hospital UK . 6 2010_04 2014_06 53 Royal Derby Hosp UK . 6 2010_07 2014_05 54 Bath, Royal United Hosp UK . 6 2011_06 2013_09 55 Salisbury Dist Hosp UK . 6 2010_09 2013_04 56 Swindon, Great Western Hosp UK . 5 2010_09 2013_11 57 London, Royal Marsden Hosp UK . 5 2010_04 2013_04 58 Lincoln County Hosp UK . 5 2008_08 2013_03 59 Odette Cancer Centre Canada . 5 2011_11 2012_07 60 Weston Park Hosp UK . 5 2010_11 2012_04 61 Edinburgh, Westen Gen UK . 5 2009_06 2011_09 62 Oxford, Churchill Hosp UK . 1 . 4 2011_06 2014_08 63 Birmingham, Good Hope Hosp UK . 4 2011_09 2014_03 64 Forth Valley Royal Hosp UK . 4 2011_05 2014_03 65 Torbay District Gen Hosp UK . 4 2011_05 2013_07 66 Aarhus University Hosp Denmark . 1 3 2013_08 2014_09 67 Swansea, Singleton Hosp UK . 3 2012_11 2014_05 68 Redditch, Alexandra Hosp UK . 3 2012_03 2013_09 69 Grand River Regional Cancer Centre Canada . 3 2012_11 2013_03 70 Scunthorpe Gen Hosp UK . 3 2010_11 2012_03 71 Bournemouth,Royal Bournemouth Hosp UK . 3 2011_02 2012_02 72 London, Regional Cancer Program Canada . 3 2011_03 2011_07 73 Cambridge Addenbrooke's Hosp UK . 3 2008_02 2011_02 74 Manchester, Withington Hosp UK . 3 2010_09 2011_01 75 Aalborg University Hosp Denmark . 1 1 2 2014_08 2014_09 76 London, St. George's Hosp UK . 1 . 2 2011_08 2014_08 77 Colchester, Essex County Hospital UK 1 . 2 2012_11 2014_07 78 Middlesbrough James Cook Univ Hosp UK 1 . 2 2009_03 2014_07 79 Peterborough District Hosp UK . 2 2012_10 2014_06 80 Royal Sussex C Hosp UK . 2 2012_11 2013_08 81 Ayr Hosp UK . 2 2009_12 2013_03 82 Hereford County Hospital UK . 2 2012_05 2013_03 83 Ottawa Health Research Inst Canada . 2 2012_02 2013_03 84 London, St Mary's Hosp UK . 2 2011_02 2012_06 85 Vancouver Cancer Centre Canada . 2 2009_06 2011_09 86 London, Charing Cross Hosp UK . 2 2010_05 2011_05 87 Dorset County Hosp UK . 2 2009_09 2010_10 88 Halifax NS, Q Elizabeth II Health Centre Canada . 2 2010_03 2010_10 89 Glasgow, W Scotland Cancer Centre UK . 2 2009_05 2009_11 90 Yeovil District Hosp UK . 1 2014_06 2014_06 91 Centre Hosp. Regional Trois-Rivieries Canada . 1 2013_10 2013_10 92 Cornwall, Royal Cornwall Hosp UK . 1 2013_08 2013_08 93 Royal Liverpool Uni Hosp UK . 1 2013_08 2013_08 94 Wycombe Hosp UK . 1 2013_08 2013_08 95 Bangor, Ysbyty Gwynedd UK . 1 2013_01 2013_01 96 Aberdeen Royal Inf UK . 1 2012_06 2012_06 97 Sutton-In-Ashfield, King's Mill Hosp UK . 1 2012_06 2012_06 98 Eastbourne District General Hosp UK . 1 2012_01 2012_01 99 Chelmsford, Broomfield Hosp UK . 1 2011_03 2011_03 100 Chester, Countess of Chester UK . 1 2010_12 2010_12 101 Edinburgh, Weston Gen Hosp UK . 1 2010_12 2010_12 102 Reading, Royal Berkshire Hosp UK . 1 2010_12 2010_12 103 London, Hammersmith UK . 1 2010_10 2010_10 104 Airedale Gen Hosp UK . 1 2010_09 2010_09 105 London, Royal Free UK . 1 2010_08 2010_08 Table 5 - Characteristics at randomisation Allocated treatment - RADICALS-RT Variable Early RT Deferred RT Planned RT schedule 1 52.5Gy in 20 fractions 159 (36%) 155 (36%) 66Gy in 33 fractions 282 (64%) 278 (64%) Other (discuss with MRC CTU or NCIC CTG) 3 (1%) 2 (0%) Planned RT target 1 Prostate bed 425 (96%) 427 (98%) Prostate bed and pelvic lymph nodes 19 (4%) 8 (2%) Choice of hormone therapy of allocated 1 LHRH agonist with short course anti-androgen 99 (72%) 91 (72%) Bicalutamide monotherapy 150 mg/daily 38 (28%) 34 (27%) LHRH antagonist 0 (0%) 2 (2%) Age at randomisation 2 65 (8) [435] 65 (8) [426] 1: n (column percentage) 2: Median (IQR) [n] Table 6 - Baseline characteristics Allocated treatment - RADICALS-RT Variable Early RT Deferred RT Gleason score 1 <7 38 (9%) 35 (8%) =7 334 (76%) 327 (76%) >7 68 (15%) 68 (16%) Extraprostatic extension 1 Absent 128 (29%) 135 (32%) Present 301 (68%) 276 (64%) Not known 11 (3%) 17 (4%) Positive margins 1 Absent 157 (36%) 160 (37%) Present 283 (64%) 270 (63%) Seminal Vesicle involvement? 1 Absent 361 (82%) 353 (82%) Present 74 (17%) 69 (16%) Not known 5 (1%) 8 (2%) Radical prostatectomy technique 1 Open retropubic 159 (36%) 150 (35%) Open Perineal 8 (2%) 8 (2%) Laparoscopic 105 (24%) 88 (21%) Robotic 133 (30%) 146 (35%) Not known 32 (7%) 31 (7%) Node dissection performed? 1 No 192 (44%) 184 (43%) Yes, nodes negative 224 (51%) 231 (55%) Yes, nodes positive 21 (5%) 8 (2%) Charlson comorbidity index 1 0 366 (84%) 345 (82%) 1 52 (12%) 61 (14%) 2 10 (2%) 12 (3%) 3 7 (2%) 4 (1%) 4 2 (0%) 0 (0%) 1: n (column percentage) Note: data only available for patients who have returned a baseline form .