Prostate Testing for Cancer and Treatment (ProtecT) Feasibility Study
| ISRCTN | ISRCTN08435261 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08435261 |
| Secondary identifying numbers | HTA 96/20/06 |
- Submission date
- 20/11/2003
- Registration date
- 20/11/2003
- Last edited
- 26/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jenny Donovan
Scientific
Scientific
Department of Social Medicine
University of Bristol
Bristol
BS8 2PR
United Kingdom
| Phone | +44 (0)117 928 7214 |
|---|---|
| jenny.donovan@bristol.ac.uk |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Patient information can be found at: http://www.epi.bris.ac.uk/protect/takingpart/takingpart.htm |
| Scientific title | |
| Study acronym | ProtecT |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/1999 |
| Completion date | 31/05/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 150 |
| Key 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. |
| Key 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). |
| Date of first enrolment | 01/06/1999 |
| Date of final enrolment | 31/05/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Social Medicine
Bristol
BS8 2PR
United Kingdom
BS8 2PR
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/10/2002 | Yes | No | |
| Results article | results on patients' perceptions of randomisation and reasons for consent or refusal to participate in the ProtecT study | 01/06/2003 | Yes | No | |
| Results article | results on the effectiveness of nurses and surgeons in recruiting patients | 01/07/2003 | Yes | No | |
| Other publications | HTA monograph | 01/10/2003 | Yes | No |
