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ISRCTN
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ISRCTN20141297
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ClinicalTrials.gov identifier
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NCT00632983
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Public title
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The ProtecT trial - Evaluating the effectiveness of treatment for clinically localised prostate cancer
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Scientific title
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Acronym
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ProtecT
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Serial number at source
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HTA 96/20/99
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Study hypothesis
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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.
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Ethics approval
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Trent Multi-centre Research Ethics Committee (Trent MREC), approved on 21/06/2001 (ref: 01/4/025)
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Prostate cancer
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Participants - inclusion criteria
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Men aged 50-69 years from the community, localised prostate cancer for eligibility for randomisation
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/06/2001
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Anticipated end date
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31/12/2013
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Status of trial
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Ongoing |
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Patient information material
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Patient information can be found at: http://www.epi.bris.ac.uk/protect/takingpart/takingpart.htm
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Target number of participants
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230,000
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Interventions
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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
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.epi.bris.ac.uk/protect/
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16978272
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18006969
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Contact name
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Prof
F C
Hamdy
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Address
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Head of Urology
Department of Clinical Sciences
Royal Hallamshire Hospital
I floor
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City/town
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Sheffield
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Zip/Postcode
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S10 2JF
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Country
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United Kingdom
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Tel
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+44 (0)114 271 2154
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Fax
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+44 (0)114 2712268
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Email
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F.C.Hamdy@sheffield.ac.uk
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Sponsor
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University of Sheffield (UK)
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Address
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Western Bank
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City/town
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Sheffield
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Zip/Postcode
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S10 2TN
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Country
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United Kingdom
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Sponsor website:
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http://www.shef.ac.uk
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Date applied
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14/10/2002
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Last edited
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26/02/2009
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Date ISRCTN assigned
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14/10/2002
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