Direct link to this page: http://www.hta.ac.uk/1230

Details of HTA project in progress

Last updated: 31 August 2010 - Next update due: 7 September 2010



Research type:

 Primary Research (e.g. trial)  

Project title:

 The ProtecT trial - evaluating the effectiveness of treatments for clinically localised prostate cancer 
Outputs in journals arising from this project

Project ref:

 96/20/99 

Cost:

 £34,172,557 This project has been commissioned by the HTA Programme on behalf of the Department of Health 

Chief Investigator :

 Professor Freddie Hamdy, Nuffield Professor of Surgery, John Radcliffe Hospital, University of Oxford

Project Website

 http://www.epi.bris.ac.uk/protect

Project Email

info-protect@bristol.ac.uk 

Start Date:

 June 2001  

Estimated date of publication in HTA journal series:

 Early 2015. This date takes account of time for report preparation and printing based on current average times for these activities.  

Project Abstract:

 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.
4) To collect material suitable for basic science research, and develop a network for collaborative research.  

MeSH* index primary terms:

 PROSTATIC-NEOPLASMS Q-surgery; PROSTATIC-NEOPLASMS Q-radiotherapy; PROSTATECTOMY Q-methods; COMBINED-MODALITY-THERAPY; COSTS-AND-COST-ANALYSIS 

MeSH* index secondary terms:

 HUMAN; TREATMENT-OUTCOME; MALE; MIDDLE-AGE; AGED; RANDOMIZED-CONTROLLED-TRIAL; CLINICAL-TRIAL; QUALITY-OF-LIFE; SURVIVAL-ANALYSIS; DISEASE-PROGRESSION; COMPARATIVE-STUDY; FOLLOW-UP-STUDIES 

NRR* number, if applicable:

 N0484104336 (*National Research Register). The National Research Register was a public database of ongoing and recently completed research projects funded by, or of interest to, the United Kingdom's National Health Service (NHS). It is now an archive of projects from early 2000 to September 2007. Search the NRR archive.

ISRCTN* number:

ISRCTN 20141297 (*International Standard Randomised Controlled Trial Number) 
URL of this project on the Controlled Trials Website:
http://www.controlled-trials.com/ISRCTN20141297 

Project Protocol:

 Project protocol not available

URL of this page:

http://www.hta.ac.uk/1230

Outputs from this project

  • Donovan, J; Mills, N; Smith, M; Brindle, L; Jacoby, A; Peters, T; Frankel, S; Neal, D; Hamdy, F. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. British Medical Journal; 2002: 325, 766-70.
  • Frankel, S; Smith, GD; Donovan, J; Neal, D. Screening for prostate cancer. Lancet. 2003; 361: 1122-28.
  • Hamdy, FC; Donovan, JL; Lane, JA; Neal, DE. Ethics of clinical trials from bayesian perspective: randomisation to clinical trials may solve dilemma of treatment choice in prostate cancer.. British Medical Journal June 28,326(7404):1456.
  • Oliver, S; Gunnell, D; Donovan, J; Peters, T; Persad, R; Gillatt, D; Pearce, A; Neal, D; Hamdy, FC; Holly, J. Screen-detected prostate cancer and the insulin-like growth factor (IGF)-axis: results of a population-based case-control study.. International Journal Cancer: 108, 887-892 (2004) doi: 10.1002/ijc.11631.
  • Mills, N; Donovan, JL; Smith, M; Jacoby, A; Neal, DE; Hamdy, FC. Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the protecT study.. Controlled Clinical Trials 2003; 24:272-282 doi: 10.1016/S0197-2456(03)00020-5.
  • Gunnell, D; Oliver, SE; Donovan, JL; Peters, TJ; Persad, R; Gillatt, D; Hamdy, FC; Neal, DE; Holly, J. Are diet-prostate cancer associations mediated by the IGF axis? A cross-sectional analysis of diet. IFG-I and IGFBP-3 in middle-aged men.. British Journal of Cancer 2003; 88(11):1682-6.
  • Oliver, SE; Donovan, JL; Peters, TJ; Frankel, SJ; Hamdy, FC; Neal, DE. Recent trends in the use of radical prostatectomy in England: the epidemiology of diffusion. BJU International 91, 331-336 doi: 10.1046/j.1464-4096.2003.04083.x.
  • Oliver, SE; Barrass, B; Gunnell, DJ; Donovan, JL; Peters, TJ; Persad, RA; Gillatt, D; Neal, DE; Hamdy, FC; Holly, JMP. Serum IGF-I is positively associated with serum PSA in middle-aged men without evidence of prostate cancer. Cancer Epidemiology, Biomarkers & Prevention Vol 13 163-165, January 2004.
  • Gunnell, D; Oliver, SE; Donovan, JL; Peters, TJ; Gillatt, D; Persad, R; Hamdy, FC; Neal, DE; Holly, JMP. Do height-related variations in insulin-like growth factors underlie the associations of stature with adult chronic disease. The Journal of Clinical Endocrinology & Metabolism 89(1):213-218 doi: 10.1210/jc.2003-030507.
  • Donovan, JL; Martin, MM; Neal, DE; Hamdy, FC. Prostate Cancer: screening approaches. British Journal of Hospital Medicine, November 2005, vol 66, no 11.
  • Martin, R; Smith, GD; Donovan, J. Does current evidence justify prostate cancer screening in Europe?. Nature Clinical Practice.
  • Bosch, JLRH; Tilling, K; Bohnen, AM; Donovan, JL. Establishing Normal Reference Ranges for PSA Change With Age in a Population-Based Study: The Krimpen Study. The Prostate 66:335-343 (2006).
  • Oxley, JJ. Reviewing negative prostatic core biopsies for the multidisciplinary team meeting. Histopathology 2005 Dec;47(6);643-4.
  • Bosch, JLHR; Tilling, K; Bohnen, AM; Donovan, JL. Eastablishing Normal Reference Ranges for pSA Change with Age in a Population-Based Study: The Krimpen Study. The Prostate 66:355-343(2006).
  • Martin, R; Donovan, J; Verne, J. Screening for prostate cancer. no journal given Volume No. 11 Issue No: 1 January/February 2006.
  • Mills, N; Metcalfe, C; Ronsman, C; Davis, M; Lane, A; Sterne, JAC; Peters, TJ; Hamdy, FC; Neal, DE; Donovan, JL. A comparison of socio-demographic and psychological factors between patients consenting to randomisation and those selecting treatment (the ProtecT study). Contemporary Clinical Trials 27 (2006) 413-419.
  • Martin, RM; Gunnell, D; Hamdy, F; Neal, D; Lane, A; Donovan, J. Continuing controversy over monitoring men with localized prostate cancer: a systematic review of programs in the prostate specific antigen era. The Journal of Urology Volume 176, Issue 2, August 2006, Pages 439-449.
  • Mills, N; Metcalfe, C; Ronsmans, C; Davis, M; Lane, A; Sterne, JAC; Peters, TJ; Hamdy, FC; Neal, DE; Donovan, JL. A comparison of socio-demographic and psychological factors between patients consenting to randomisation and those selecting treatment (the ProtecT study). Contemporary Clinical Trials Volume 27, Issue 5, October 2006, Pages 413-419.
  • Brindle, L; Oliver, SE; Dedman, D; Donovan, JL; Neal, DE; Hamdy, FC; Lane, JA; Peters, TJ. Measuring the psycho-social impact of testing for prostate cancer in men having prostatic biopsy: findings of a community-based study in the UK. BJU Int. 2006 Oct;98(4):777-82..
  • Lane, JA; Howson, J; Donovan, JL; Goepel, J; Dedman, DJ; Down, L; Turner, EL; Neal, DE; Hamdy, FC. Prostate cancer detection in an unselected young population: experience of the ProtecT study. BMJ 2007: 335:1139.
  • Rosario, D; Lane, JA; Metcalfe, C; Catto, JW; Dedman, D; Donovan, JL; Neal, DE; Hamdy, FC. Contribution of repeat PSA test to prostate cancer risk assessment - experience from the ProtecT study. Eur Urol (published online).
  • Salter, L. The ProtecT study. Oncology Times. 2007: 29 (23).
  • Lane, JA; Howson, J; Donovan, J; Goepel, J; Dedman, D; Down, L; Turner, E; Neal,, D; Hamdy, FC. Detection of prosate cancer in unselected young men: prospective cohort nested within a randomised controlled trial. BMJ.
  • Steginga, SK; Turner, EL; Donovan, JL. The Decision-Related Psychosocial Concerns of Men with Localised Prostate Cancer: Targets for Intervention and Research. World Journal of Urology, 2008 (in press).
  • Avery, KN; Metcalfe, C; Blazeby, J; Lane, JA; Neal, DE; Hamdy, FC; Donovan, JL. PSA testing and biopsy: Are self-reported lower urinary tract symptoms and health related quality of life associated with the decisions to undergo those processes. BJUI.
  • Collin, S; Metcalfe, C; Martin, R; Donovan, J; Lane, JA; Davis, M; Neal, DE; Hamdy, FC; Martin, RM. Associations of lower urinary tract symptoms with prostate-specific antigen levels and screen-detected localized and advanced prostate cancer: a case-control study nested within the UK population-based ProtecT study. BJUI.
  • Collins, S; Martin, R; Metcalfe, C; Gunnell, D; Albertsen, P; Neal, D; Hamdy, FC; Stephens, P; lane, JA; Moore, R; Donovan, J. Diverging trends in prostate cancer mortality in the USA and UK: consequence of treatment, screening or artefact?. Lancet Oncology 2008:9,445-452.
  • Down, L; Metcalfe, C; Avery, K; Noble, S; Lane, JA; Neal, DE; Hamdy, FC; Donovan, JL. Practice level factors distinguishing general practitioners who more readily participated in a large randomised trial. Journal of Clinical Epidemiology.
  • Donovan, JL; Lane, JA; Peters, TJ; Brindle, L; Salter, E; Gillatt, D; Powell, P; Bollina, P; Neal, DE; Hamdy, FC. Improving randomisation and informed consent in multi-centre trials: the development and evaluation of a complex intervention. Journal of Clinical Epidemiology.
  • Metcalfe, C; Martin, RM; Noble, S; Lane, JA; Hamdy, FC; Neal, DE; Donovan, JL. Low risk research using routinely collected identifiable health information without informed consent: Encounter with the Patient Information Advisory Group. Journal of Medical Ethics, 34(1): 37-40.
  • Eeles, RA; Kote-Jarai, Z; Giles, GG; Al Olama, AA; Guy, M; Jugurnauth, SK; Mulholland, S; Daniel, A; Leongamornlert, DA; Edwards, SM; Morrison, J; Field, HI; Southey, MC; Severi, G; Donovan, JL; Hamdy, FC; Dearnaley, DP; Muir, KM; Smith, C; Bagnato, M; Ardern-Jones, AT; Hall, AM; O'Brien, LT; Gehr-Swain, BN; Wilkinson, RA; Cox, A; Lewis, S; Brown, PM; Jhavar, SG; Tymrakiewicz, M; Lophatananon, A; Bryant, SL; The UK Genetic Prostate Cancer Study Collaborators/British Association of Urological Surgeons section of Oncology; The UK ProtecT Study Collaborators; Horwich, A; Huddart, RA; Khoo, V; Parker, CC; Woodhouse, CJ; Thompson, A; Christimas, T; Ogden, C; Fisher, C; Jamieson, C; Cooper, CS; English, DR; Hopper, JL; Neal, DE; Easton, DF. Multiple newly identified loci associated with prostate cancer susceptibility. Nature Genetics 2008.
  • Zuccolo, L; Harris, R; Gunnell, D; Oliver, S; Lane, JA; Davis, M; Donovan, JL; Neal, DE; Hamdy, FC; Beynon, R; Savovic, J; Martin, R. Height and prostate cancer risk: a large nested case-control study (ProtecT) and metaanaiysis. Cancer Epidemiology Biomarkers and Prevention 2008; (in press).
  • Ghoussaini, M; Song, H; Koessler, T; Olama, A; Zsofia, K-J; Driver, K; Pooley, KA; Ramus, S; Kjaaer, K; Hodgall, E; DiCioccio, RA; Whittemore, A; Gayther, SA; Giles, GG; Guy M, Edwards, SM; Morrison, J; Donovan, JL; Hamdy, FC; Dearnaley, DP; Arden-Jones, AT; Hall, AL; O'Brien, LT; Gehr-Swain, BN; Wilkinson, RA; Brown, PM; The UK Genetic Prostate Cancer Study Collaborators/British Association of Urological Surgeons' Section of Oncology; The UK ProtecT Study Collaborators; Hopper, JL; Neal, DE; Pharaoh, PDP; Ponder, BAJ; Eeles, RA; Easton, DF; Dunning, AM. Multiple Loci with different Cancer Specificities Within the 8q24 Gene desert. JNCI 2008 Jun 24.
  • Macefield, R; Lane, JA; Metcalfe, C; Down, L; Hamdy, FC; Neal, DE; Donovan, JL.. Do the risk factors of age, family history of prostate cancer or a higher prostate specific antigen level raise anxiety at prostate biopsy?. European Journal of Cancer 45: 2569-2573.
  • Wade, J; Lane, JA; Donovan, JL; Neal, DE; Hamdy, FC. It's not only what you say, it's also how you say it: opening the 'black box' of recruitment to randomised controlled trials. Social Science & Medicine, 2009:68(11)2018-2028.
  • Moore, AL; Lane, JA; Dimitropoulou, P; Donovan, JL; Hamdy, FC; Greenberg, DC; Brown, C; Martin, R; Neal, DE. The ProtecT trial: Population based PSA testing in the UK leads to stage migration. BJU International, 2009:104(11)1592-1598.
  • Collin, S; Martin, R; Lewis, S.. Association of Folate-Pathway Gene Polymorphisms with the Risk of Prostate Cancer: a Population-Based Nested Case-Control Study, Systematic Review, and Meta-analysis. Cancer Epidemiology, Biomarkers and Prevention 18: 2528-2539.
  • Chen L; Davey Smith G; Evans DM; Cox A; Lawlor DA; Donovan J; Yuan W; Day INM; Martin RM; Lane A; Rodriguez S; Davis M; Zuccolo L; Collin S; Hamdy F; Neal D.. Genetic Variants in the Vitamin D Receptor Are Associated with Advanced Prostate Cancer at Diagnosis: Findings from the Prostate Testing for Cancer and Treatment Study and a Systematic Review. Cancer Epidemiology Biomarkers and Prevention 18: 2874-2881.
  • Turner, EL; Lane, JA; Metcalfe, C; Down, L; Hamdy, FC; Neal, DE; Donovan, JL; Vedhara, K. Psychological distress and prostate specific antigen levels in men with and without prostate cancer. Brain Behaviour Immunity 2009 Nov;23(8):1073-8.
  • Collin, S; Metcalfe, C; Donovan, J; Lane, A; Neal, D; Hamdy, F; Davis, M; Martin, R. Associations of sexual dysfunction symptoms with PSA-detected localized and advanced prostate cancer: a case-control study nested within the UK population-based ProtecT (Prostate testing for cancer and Treatment) study.. European Journal of Cancer.
  • Kote-Jarai, Z; Leogamornlert, DA; Tymrakiewicz, M; Field, H; Guy, M; Al Olama, AA; Morrison, J; O'Brien, L; Wilkinson, R; Hall, A; Sawyer, E; Muir, K; Hamdy, F; Donovan, J; Neal, D; Easton, D. Mutation analysis of the MSMB gene in familial prostate cancer. British Journal of Cancer 102: 414-418..
  • Whitaker HC; Warren, AY; Eeles, R; Kote-Jarai, Z; Neal, DE.. The Potential Value of Microseminoprotein-beta as a Prostate Cancer Biomarker and Therapeutic Target. Prostate 70: 333-340.
  • Tilling, K; Garmo, H; Metcalfe, C. Development of a New Method for Monitoring Prostate-Specific Antigen Changes in Men with Localised Prostate Cancer: A Comparison of Observational Cohorts.. European Urology 57: 446-452.
  • Turner, EL; Lane, JA; Donovan, JL; Davis, MJ; Metcalfe, C; Neal, DE; Hamdy, FC; Martin RM. Association of diabetes mellitus with prostate cancer: nested case-control study (ProtecT: Prostate testing for cancer and Treatment).. International Journal of Cancer.
  • Turner, E L; Lane, J A; Donovan, J L; Davis, M J; Metcalfe, C; Neal, D E; Hamdy, F C; Martin, R M. Association of diabetes mellitus with prostate cancer: nested case control study (Prostate testing for cancer and Treatment study). International Journal of Cancer.
  • Macefield, RC; Metcalfe, C; Lane, JA; Donovan, JL; Avery, KNL; Blazeby, JM; Down, L; Neal, DE; Hamdy, FC; Vedhara, K. Impact of prostate cancer testing: an evaluation of the emotional consequences of a negative biopsy result. British Journal of Cancer, 2010:1-6.
  • Vedhara, K; Avery, K; Metcalfe, C; Lane, A; Down, L; Donovan, J; Neal, D; Hamdy, F.. Impact of prostate cancer testing: an evaluation of the emotional consequences of a negative biopsy result.. British Journal of Cancer 2010 102: 1335-1340.
  • Collin, S M; Metcalfe, C; Refsum, H; Lewis, S J; Zuccolo, L; Smith, G D; Chen, L; Harris, R; Davis, M; Marsden, G; Johnston, C; Lane, J A; Ebbing, M; Bønaa, K H; Nygård, O; Ueland, P M; Grau, M V; Baron, J A; Donovan, J L; Neal, D E; Hamdy, f C; Smith, A D; Martin, R M. Circulating Folate, Vitamin B12, Homocysteine, Vitamin B12 Transport Proteins, and Risk of Prostate Cancer: a Case Control Study, Systematic Review, and Meta-analysis. Cancer Epidemiology, Biomarkers & Prevention.
  • Murad, AS; Davey; Smith, G; Lewis, S; Cox, A; Hamdy, FC; Neal, DE; Donovan J; Martin, RM.. A polymorphism in the glucokinase gene that raises plasma fasting glucose, rs1799884, is associated with diabetes mellitus and prostate cancer. International Journal of Molecular Epidemiology and Genetics 1: 175-183..
  • Rowlands, M; Holly, J M P; Gunnell, D; Gilbert, R; Donovan, J; Lane, A; Marsden, G; Collin, S M; Hamdy, F; Neal, D E; Martin, R M. The relation between adiposity throughout the life course and variation in IGFs and IGFBPs: evidence from the ProtecT (Prostate testing for cancer and Treatment). Cancer Causes Control.
Tue, 31 Aug 2010 15:42:14 +0100

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