| Source of record | UK Trials |
| ISRCTN | ISRCTN20141297 |
| Date ISRCTN assigned | 14/10/2002 |
| Local reference number(s) | HTA 96/20/99 |
| Public title | The ProtecT trial - Evaluating the effectiveness of treatment for clinically localised prostate cancer |
| Scientific title |
|
| Acronym | ProtecT |
| Disease/condition/study domain | Prostate cancer |
| Study hypothesis | The overall aim is to evaluate the effectiveness, cost-effectiveness and acceptability of treatments for men with localised prostate cancer within the context of a pragmatic randomised controlled trial. This will compare 3 treatments (active monitoring, radical prostatectomy and radical radiotherapy). Specific objectives are as follows:
1. To assess survival at 5, 10 years and 15 years following treatment
2. To investigate a number of short and medium-term outcomes, including: disease progression (biochemical and clinical), treatment complications, lower urinary tract symptoms, psychosocial impact of case-finding and treatment, including generic health status, quality of life and sexual function
3. To estimate the resource use and costs of case-finding, treatment and follow-up, and to compare costs and outcomes of treatment in terms of survival and health related quality of life. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Men aged 50-69 years from the community, localised prostate cancer for eligibility for randomisation |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material | Patient information can be found at: http://www.epi.bris.ac.uk/protect/takingpart/takingpart.htm |
| Anticipated start date | 01/06/2001 |
| Anticipated end date | 31/12/2013 |
| Status of trial | Ongoing |
| Target number of participants | 230,000 |
| Interventions | Please note that, as of 11 January 2008, the anticipated end date of this trial has been updated from 1 June 2006 to 31 December 2013.
Interventions:
1. Radical prostatectomy
2. Radical radiotherapy
3. Active monitoring of prostate specific antigen (PSA) levels
See details of ISRCTN08435261: ProtecT feasibility on http://www.controlled-trials.com/ISRCTN08435261 and details of ISRCTN92187251: The CAP (Comparison Arm for ProtecT) study on http://www.controlled-trials.com/ISRCTN92187251 |
| Primary outcome measure(s) | 1. Disease progression (biochemical and clinical)
2. Treatment complications
3. Lower urinary tract symptoms
4. Psychosocial impact of case-finding and treatment including generic health status, quality of life and sexual function |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Trial website | http://www.epi.bris.ac.uk/protect/ |
| Publications | Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=16978272
2. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=18006969 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | University of Sheffield (UK) |
| Sponsor details | Western Bank
Sheffield
United Kingdom
S10 2TN |
| Sponsor website | http://www.shef.ac.uk |
| Contact name | Prof FC Hamdy |
| Contact details | Head of Urology
Department of Clinical Sciences
Royal Hallamshire Hospital
I floor
Sheffield
United Kingdom
S10 2JF |
| Contact telephone | +44 (0)114 271 2154 |
| Contact fax | +44 (0)114 2712268 |
| Contact email | F.C.Hamdy@sheffield.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN20141297 |
| Date last extracted from ISRCTN register | 17/04/2008 |
