ProtecT study

ProtecT study

Lead Nurse meeting

October 2005

ProtecT study

Recruitment and case-finding

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

PCC attended June-August 2005

ProtecT study

PCC attended last 12 months

target

ProtecT study

Total study accrual

ProtecT study

Randomisations 2001-2005

ProtecT study

Randomisation

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

Randomisations in 2005

3/4 cases/mth randomised x 9 mths

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

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

Schedules August - August

ProtecT study

ProtecT study

Exclusions in ProtecT

PCC exclusions and Consent 3

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

Exclusions at PCC: June-Sept

ProtecT study

ProtecT study

Protocol changes and Information sheet II

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