Condition category
Cancer
Date applied
20/11/2003
Date assigned
20/11/2003
Last edited
26/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.epi.bris.ac.uk/protect/

Contact information

Type

Scientific

Primary contact

Prof Jenny Donovan

ORCID ID

Contact details

Department of Social Medicine
University of Bristol
Bristol
BS8 2PR
United Kingdom
+44 (0)117 928 7214
jenny.donovan@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/20/06

Study information

Scientific title

Acronym

ProtecT

Study hypothesis

The overall aim was to evaluate the feasibility of a randomised controlled trial (RCT) of treatments for localised prostate cancer, including:
1. Feasibility of ‘case-finding’ in the community (including the reliability and psychosocial impact of PSA testing)
2. Determining the most efficient and effective design for a major trial of treatments
3. Randomised trial of recruitment strategies
4. Piloting outcome measures and procedures for the main trial of treatments

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Patient information can be found at: http://www.epi.bris.ac.uk/protect/takingpart/takingpart.htm

Condition

Prostate cancer

Intervention

The study was an RCT of treatment preceded by case-finding in the community, with qualitative research methods integrated at each stage. Men with confirmed localised prostate cancer were asked to consent to randomisation between a nurse or urologist for an ‘information’ appointment to discuss recruitment to the treatment trial. In the information appointment, the need for a trial was explained in detail, along with the advantages and disadvantages of each treatment, and the recruiter attempted to randomise the patient to the treatment trial or reach a patient-led preference for a treatment. All men, whether randomised or not, were asked to consent to be followed-up, and these formed a pilot for the proposed main trial.

See details of ProtecT main trial on http://www.controlled-trials.com/ISRCTN20141297

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary outcome was the proportion of patients accepting randomisation to the treatment trial. Number of eligible patients randomised by nurses and urologists

Secondary outcome measures

Cost effectiveness of nurses and urologists

Overall trial start date

01/06/1999

Overall trial end date

31/05/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Men aged 50-69 years from specific primary care centres in the three cities were invited to attend a 30-minute prostate check clinic appointment in which they were informed about the study and asked to consent to a prostate specific antigen (PSA) test. Men with a raised PSA (initially ≥3.0 ng/ml if 50–59 years; ≥4.0 ng/ml if 60–69 years; but changed to ≥3.0 ng/ml for all men after 1 year) were invited for biopsy. Men with confirmed localised prostate cancer were invited to participate in a randomised trial of recruitment strategies.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

150

Participant exclusion criteria

Men considered by the GP to be unfit for any of the potential treatments (ie those terminally ill or with serious co-morbidity).

Recruitment start date

01/06/1999

Recruitment end date

31/05/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Social Medicine
Bristol
BS8 2PR
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12364308
2003 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/12709289
2003 results on patients' perceptions of randomisation and reasons for consent or refusal to participate in the ProtecT study in http://www.ncbi.nlm.nih.gov/pubmed/12757993
2003 results on the effectiveness of nurses and surgeons in recruiting patients in http://www.ncbi.nlm.nih.gov/pubmed/12921927

Publication citations

  1. Results

    Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, Frankel S, Neal D, Hamdy F, Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult., BMJ, 2002, 325, 7367, 766-770.

  2. HTA monograph

    Donovan J, Hamdy F, Neal D, Peters T, Oliver S, Brindle L, Jewell D, Powell P, Gillatt D, Dedman D, Mills N, Smith M, Noble S, Lane A, , Prostate Testing for Cancer and Treatment (ProtecT) feasibility study., Health Technol Assess, 2003, 7, 14, 1-88.

  3. Results on the effectiveness of nurses and surgeons in recruiting patients

    Donovan JL, Peters TJ, Noble S, Powell P, Gillatt D, Oliver SE, Lane JA, Neal DE, Hamdy FC, , Who can best recruit to randomized trials? Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study)., J Clin Epidemiol, 2003, 56, 7, 605-609.

  4. Mills N, Donovan JL, Smith M, Jacoby A, Neal DE, Hamdy FC, Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study., Control Clin Trials, 2003, 24, 3, 272-282.

Additional files

Editorial Notes