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ProtecT study
Case-finding up to October 2005 118,982
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
Randomisation in 2005
Eligible Randomised Accept
Sept 2005 1206 804 (67%) 614 (76%)
2005 only 290 192 (66%) 161 (84%) (89%)
(not including pending)
ProtecT study
Acceptance of allocation by arm
Randomised Accepted allocation Changed to
Overall 780 614 (76%)
Active monitoring
263 233 (89%)
Surgery 16 RadioT 9 Brachy 3
ProtecT study
Acceptance of allocation by arm
Randomised Accepted allocation Changed to
Overall 780 614 (76%)
Active monitoring
263 233 (89%)
Surgery 16 RadioT 9 Brachy 3
Surgery 260 192 (74%)
Ac Mon 44 RadioT 17 Brachy 4
ProtecT study
Acceptance of allocation by arm
Randomised Accepted allocation Changed to
Overall 780 614 (76%)
Active monitoring
263 233 (89%)
Surgery 16 RadioT 9 Brachy 3
Surgery 260 192 (74%)
Ac Mon 44 RadioT 17 Brachy 4
Radiotherapy 257 189 (74%)
Ac Mon 36 Surgery 20 Brachy 4
ProtecT study
Acceptance of allocation last 6 months
Randomised Accepted allocation Changed to
Active monitoring
43 41 (95%) (98%)
Surgery 1
Surgery 44 34 (77%) (85%)
Ac Mon 3 RadioT 3
Radiotherapy 38 29 (76%) (85%)
Surgery 3 Ac Mon 1 Brachy 1
ProtecT study
By centre for the last year Eligible Randomised Accept
Sheffield 52 32 (62%) 26 (81%)
Newcastle 43 35 (81%) 29 (83%)*
Bristol 28 21 (75%) 18 (86%)
Cardiff 40 26 (65%) 20 (77%)
Edinburgh 24 15 (63%) 15 (100%)
Birmingham 28 12 (43%) 12(100%)
Leicester 56 45 (80%) 42 (93%)
Cambridge 52 29 (52%) 19 (66%)*
Leeds 63 45 (71%) 41 (91%)
ProtecT study
Randomisation by centre last 6 months
Eligible Randomised Accept
Sheffield 31 18 (58%)*
Newcastle 14 11 (79%)*
Bristol 10 6 (60%)
Cardiff 27 17 (63%)**
Edinburgh 13 6 (46%)*
Birmingham 14 5 (36%)***
Leicester 18 14 (78%)*
Cambridge 33 20 (61%)*
Leeds 44 28 (64%)**
ProtecT study
Randomisation by centre last 6 months
Eligible Randomised Accept
Sheffield 31 18 (58%) 14 (78%)*
Newcastle 14 11 (79%) 10 (91%)*
Bristol 10 6 (60%) 5 (83%)*
Cardiff 27 17 (63%) 14 (82%)
Edinburgh 13 6 (46%) 6 (100%)
Birmingham 14 5 (36%) 5 (100%)
Leicester 18 14 (78%) 13 (93%)*
Cambridge 33 20 (61%) 12 (60%)****
Leeds 44 28 (64%) 25 (89%)*
ProtecT study
Follow-up: treatment schedules
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
Radiotherapy (info appt November 03 – October 04)
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
Overall 803/970 (83%) Response rate lower than the last
12 months Some centres 6 mth over 90%,
others 69%or less Stress importance of the
questionnaires to the men, is the data that will influence policy
ProtecT study
Questionnaire follow-up Most recent 12 month follow-up:
240/276 questionnaire (87%)
Overall 12 month follow-up: 691/790 questionnaire (87%)
Annual follow-up thereafter 90%
ProtecT study
Schedule follow-up Most recent 12 month follow-up:
246/276 schedule (84%)
Overall 12 month follow-up: 697/790 schedule (88%)
Varies by centre
ProtecT study
Exclusions at PCC and Consent 3
Hierarchy of exclusions since February implementation OK?
Recording on PCC summary sheet and database more consistently?
Range of exclusion and health reason % over centres, already contacted some centres
Sometimes small change in wording can improve figures e.g. more time
ProtecT study
Maximum exclusions in ProtecTInvitations
Prostate check clinic
Raised PSA
Localised
5% (0-10%)Ill health
5% (0-9%) Excluded ill health
GP list6% (1-15%)
1% (0-5%)More time
5% (1-7%)Refusal
3% (1-3%)Other
5% (4-11%)No Con 3
ProtecT study
Protocol 2.2 Bone scan (disregard initial PSA) for
Gleason 8-10 PCa PSA tests not recommended by study >69 AM: ANY 50% rise in past 12 mths PSA
in 3mths and then a review if still 50%rise AM appts: twice yearly after year 1 Discourage study PSA test excluded men Complete 2nd Rx schedule if necessary
ProtecT study
Protocol 2.2: Treatments 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
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 Surgery v AM
Balancing emphasis on cure in surgery possible against AM benefits
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