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The ProtecT trial - Evaluating the effectiveness of treatment for clinically localised prostate cancer
ISRCTN ISRCTN20141297
DOI 10.1186/ISRCTN20141297
ClinicalTrials.gov identifier NCT00632983
EudraCT number
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 Current hypothesis as of 14/08/2013:

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 three treatments (active monitoring, radical prostatectomy and radical radiotherapy). Specific objectives are as follows:
1. To assess survival at 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.

Previous 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

On 11/01/2008 the anticipated end date of this trial has been updated from 1 June 2006 to 31 December 2013.

On 28/04/2010 the Principal Investigator of this trial has moved from the University of Sheffield to the University of Oxford. The sponsor and contact details below have been updated accordingly.

On 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).

On 14/08/2013 the target number of participants was changed from 230,000 to 116,500
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 21/06/2001 (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.bris.ac.uk/social-community-medicine/projects/protect/
Target number of participants 116,500
Interventions Current interventions as of 14/08/2013:

1. Radical prostatectomy
2. Radical radiotherapy
3. Active monitoring: monitoring of the disease including prostate specific antigen levels

Previous 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) Primary outcome measures as of 14/08/2013:

1. Disease-specific survival at 10 years

Primary outcome measures as of 27/09/2010:

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
5. Prostate cancer specific survival
6. Overall survival

Primary outcome measures as of 14/10/2002:

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) Added 14/08/2013:

1. Overall survival
2. Disease progression (biochemical and clinical)
3. Lower urinary tract symptoms
4. Psychosocial imapct of cancer diagnosis and treatment including generic health status, quality of life and sexual function
5. Cost-effectiveness of the treatments
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website http://www.bris.ac.uk/social-community-medicine/projects/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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21047592
5. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20473853
6. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20652394
7. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20976066
8. 2012 case-control study in http://www.ncbi.nlm.nih.gov/pubmed/22106399
9. 2012 cross-sectional analysis in http://www.ncbi.nlm.nih.gov/pubmed/22527168
10. 2012 active surveillance results in http://www.ncbi.nlm.nih.gov/pubmed/22859401
11. 2012 acceptability results in http://www.ncbi.nlm.nih.gov/pubmed/23271772
12. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23085814
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
  Email 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 14/08/2013
Date ISRCTN assigned 14/10/2002
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