ProtecT study Lead Nurse meeting October 2005

ProtecT study Recruitment and case-finding

ProtecT study Case-finding up to October ,982 Invitations 59,491 (50%) Prostate check clinic attenders 5,665 (9.5%) Raised PSA 1185 (76%) Localised 192 (12%) Advanced 148 (10%) Excluded 1566 (28%) Total cancer

ProtecT study PCC attended June-August 2005

ProtecT study PCC attended last 12 months target

ProtecT study Total study accrual

ProtecT study Randomisations

ProtecT study Randomisation

ProtecT study Randomisation in 2005

ProtecT study Acceptance of allocation by arm

ProtecT study Acceptance of allocation by arm

ProtecT study Acceptance of allocation by arm

ProtecT study Acceptance of allocation last 6 months

ProtecT study By centre for the last year

ProtecT study Randomisations in /4 cases/mth randomised x 9 mths

ProtecT study Randomisation by centre last 6 months Eligible Randomised Accept Sheffield3118 (58%)* Newcastle1411 (79%)* Bristol106 (60%) Cardiff2717 (63%)** Edinburgh136 (46%)* Birmingham145 (36%)*** Leicester1814 (78%)* Cambridge3320 (61%)* Leeds4428 (64%)**

ProtecT study Randomisation by centre last 6 months

ProtecT study Follow-up

ProtecT study Follow-up: treatment schedules u Surgery (info appt March 04 -March 05)  Surgeon schedules = 95/110 (86%) randomised participants (82% preference)  Researcher schedules = 93/110 (85%), (85% preference)  All centres are returning schedules

ProtecT study Follow-up: treatment schedules u Radiotherapy (info appt November 03 – October 04) u 35/60 returned = 58%  Schedules returned from Bristol, Cardiff and Leicester currently  What is happening in?  Sheffield  Newcastle  Edinburgh  Birmingham  Cambridge

ProtecT study 6 month questionnaire follow-up u Overall 803/970 (83%) u Response rate lower than the last 12 months u Some centres 6 mth over 90%, others 69%or less u Stress importance of the questionnaires to the men, is the data that will influence policy

ProtecT study Questionnaire follow-up u Most recent 12 month follow-up:  240/276 questionnaire (87%) u Overall 12 month follow-up:  691/790 questionnaire (87%) u Annual follow-up thereafter 90%

ProtecT study Schedule follow-up u Most recent 12 month follow-up:  246/276 schedule (84%) u Overall 12 month follow-up:  697/790 schedule (88%) u Varies by centre

ProtecT study Schedules August - August

ProtecT study

Exclusions in ProtecT PCC exclusions and Consent 3

ProtecT study Exclusions at PCC and Consent 3 u Hierarchy of exclusions since February implementation OK? u Recording on PCC summary sheet and database more consistently? u Range of exclusion and health reason % over centres, already contacted some centres u Sometimes small change in wording can improve figures e.g. more time

ProtecT study Maximum exclusions in ProtecT Invitations Prostate check clinic Raised PSA Localised 5% (0-10%) Ill health 5% (0-9%) Excluded ill health GP list 6% (1-15%) 1% (0-5%) More time 5% (1-7%) Refusal 3% (1-3%) Other 5% (4-11%) No Con 3

ProtecT study Exclusions at PCC: June-Sept

ProtecT study

Protocol changes and Information sheet II

ProtecT study Protocol 2.2 u Bone scan (disregard initial PSA) for Gleason 8-10 PCa u PSA tests not recommended by study >69 u AM: ANY 50% rise in past 12 mths PSA in 3mths and then a review if still 50%rise u AM appts: twice yearly after year 1 u Discourage study PSA test excluded men u Complete 2 nd Rx schedule if necessary

ProtecT study Protocol 2.2: Treatments u Surgery  PSA of 0.2 ng/ml or> on 3 consecutive readings after <0.1 ng/ml post-op  adjuvant radiotherapy for local progression and androgen ablation for mets. Monitoring also offered with androgen ablation at PSA =>20 u Radiotherapy  any PSA of 2.0 or >after the nadir (Houston+2)  CT/MRI of pelvis for lymphadenopathy. Discuss androgen ablation and if not used initially review at PSA of >=20 ng/ml

ProtecT study Information sheet II u Surgery v AM  Balancing emphasis on cure in surgery possible against AM benefits u Radiotherapy Gastroenterology …..  Long term database analysis USA >risk of colon & rectal Ca post-prostate radiation FIGS  MM advised radiation carries some small additional risk of cancer  NB study has no conformal radiation