Plain English Summary
Not provided at time of registration
Trial website
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 5059 years; ≥4.0 ng/ml if 6069 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
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
-
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.
-
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.
-
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.
-
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.