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04 February 2012
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| [ Print-friendly version ] |
| The ProtecT trial - Evaluating the effectiveness of treatment for clinically localised prostate cancer |
| ISRCTN | ISRCTN20141297 |
| ClinicalTrials.gov identifier | NCT00632983 |
| Public title | The ProtecT trial - Evaluating the effectiveness of treatment for clinically localised prostate cancer |
| Scientific title | |
| Acronym | ProtecT |
| Serial number at source | HTA 96/20/99 |
| 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. Details of this study can also be found at: http://www.hta.ac.uk/1230 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. Please note that as of 28/04/10 the Principal Investigator of this trial has moved from the University of Sheffield to the University Oxford. The sponsor and contact details below have been updated accordingly. Please note that as of 27/09/2010 the anticipated end date of this trial has been updated from 31 December 2013 to 31 December 2015. At this time, two primary outcome measures were added (see relevant field). |
| Lay summary | http://cancerhelp.cancerresearchuk.org/trials/a-trial-comparing-treatment-approaches-for-prostate-cancer |
| Ethics approval | Trent Multicentre Research Ethics Committee (Trent MREC), approved on 21st June 2001 (ref: 01/4/025) |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Prostate cancer |
| 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. |
| Anticipated start date | 01/06/2001 |
| Anticipated end date | 31/12/2015 |
| Status of trial | Ongoing |
| Patient information material | Patient information can be found at: http://www.epi.bris.ac.uk/protect/takingpart/takingpart.htm |
| Target number of participants | 230,000 |
| 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 Added 27/09/2010: 5. Prostate cancer specific survival 6. Overall survival |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | http://www.epi.bris.ac.uk/protect/ |
| Publications |
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16978272
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18006969 3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20372151 4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20473853 5. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20652394 6. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20976066 |
| Contact name | Prof F C Hamdy |
| Address |
Professor of Surgery and Urology
Head of Nuffield Department of Surgical Sciences Faculty of Medical Science University of Oxford John Radcliffe Hospital |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| Freddie.hamdy@nds.ox.ac.uk | |
| Sponsor | University of Oxford (UK) |
| Address |
Faculty of Medical Science
John Radcliffe Hospital |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| Sponsor website: | http://www.ox.ac.uk |
| Date applied | 14/10/2002 |
| Last edited | 01/12/2011 |
| Date ISRCTN assigned | 14/10/2002 |
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