Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: Study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial

The Lancet Oncology

Volumn 15, Issue 10, 2014, Pages 1109-1118

  Lane, J Athene ^a   Donovan, Jenny L ^a   Davis, Michael ^a   Walsh, Eleanor ^a   Dedman, Daniel ^a   Down, Liz ^a   Turner, Emma L ^a   Mason, Malcolm D ^b   Metcalfe, Chris ^a   Peters, Tim J ^a   Martin, Richard M ^a   Neal, David E ^c   Hamdy, Freddie C ^d  

^a UNIVERSITY OF BRISTOL   (United Kingdom)

^b CARDIFF UNIVERSITY   (United Kingdom)

^c CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^d UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

PROSTATE SPECIFIC ANTIGEN;

ADULT; AGED; ANDROGEN DEPRIVATION THERAPY; ARTICLE; BRACHYTHERAPY; CANCER ADJUVANT THERAPY; CANCER DIAGNOSIS; CANCER MORTALITY; CANCER SURVIVAL; COMPARATIVE EFFECTIVENESS; COMPUTER ASSISTED RADIOTHERAPY; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; EXTERNAL BEAM RADIOTHERAPY; GLEASON SCORE; HUMAN; HUMAN TISSUE; MALE; MIDDLE AGED; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT MONITORING; PHASE 3 CLINICAL TRIAL; PILOT STUDY; PROSTATE BIOPSY; PROSTATE CANCER; PROSTATECTOMY; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; BLOOD; CANCER GRADING; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; FOLLOW UP; IMMUNOHISTOCHEMISTRY; MORTALITY; NEEDLE BIOPSY; PATHOLOGY; PATIENT SELECTION; PROCEDURES; PROSTATIC NEOPLASMS; RISK ASSESSMENT; SURVIVAL; TREATMENT OUTCOME; TUMOR RECURRENCE; UNITED KINGDOM; WATCHFUL WAITING;

AGED; BIOPSY, NEEDLE; DISEASE-FREE SURVIVAL; FOLLOW-UP STUDIES; GREAT BRITAIN; HUMANS; IMMUNOHISTOCHEMISTRY; MALE; MIDDLE AGED; NEOPLASM GRADING; NEOPLASM RECURRENCE, LOCAL; PATIENT SELECTION; PROSTATE-SPECIFIC ANTIGEN; PROSTATECTOMY; PROSTATIC NEOPLASMS; RADIOTHERAPY, CONFORMAL; RISK ASSESSMENT; SURVIVAL ANALYSIS; TREATMENT OUTCOME; WATCHFUL WAITING;

EID: 84908569444     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)70361-4     Document Type: Article

References (36)

1. Siegel R, Naishadham D, Jemal A Cancer statistics, 2013. CA Cancer J Clin 2013, 63:11-30.
2. Cancer Stats: Cancer Statistics for the UK Cancer Research UK, (accessed July 21, 2014). http://www.cancerresearchuk.org/cancer-info/cancerstats/.
3. Schröder FH, Hugosson J, Roobol MJ, et al. Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. Lancet Oncol 2014, published online Aug 7. 10.1016/S0140-6736(14)60525-0.
4. Hugosson J, Carlsson S, Aus G, et al. Mortality results from the Göteborg randomised population-based prostate-cancer screening trial. Lancet Oncol 2010, 11:725-732.
5. Andriole GL, Crawford ED, Grubb RL, et al. Prostate cancer screening in the randomized Prostate, Lung, Colorectal, and Ovarian cancer screening trial: mortality results after 13 years of follow-up. J Natl Cancer Inst 2012, 104:125-132.
6. Wilt TJ, Brawer MK, Jones KM, et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012, 367:203-213.
7. Bill-Axelson A, Holmberg L, Ruutu M, et al. Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med 2011, 364:1708-1717.
8. Donovan J, Hamdy F, Neal D, Peters T, Oliver S Prostate testing for cancer and treatment (ProtecT) feasibility study. Health Technol Assess 2003, 7:42.
9. Lane JA, Hamdy FC, Martin RM, Turner EL, Neal DE, Donovan JL Latest results from the UK trials evaluating prostate cancer screening and treatment: the CAP and ProtecT studies. Eur J Cancer 2010, 46:3095-3101.
10. Turner EL, Metcalfe C, Donovan JL, et al. Design and preliminary recruitment results of the cluster randomised trial of PSA testing for prostate cancer (CAP). Br J Cancer 2014, 110:2829-2836.
11. Donovan JL, Lane JA, Peters TJ, et al. Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. J Clin Epidemiol 2009, 62:29-36.
12. Lane JA, Wade J, Down L, et al. A Peer Review Intervention for Monitoring and Evaluating sites (PRIME) that improved randomized controlled trial conduct and performance. J Clin Epidemiol 2011, 64:628-636.
13. Dearnaley DP, Sydes MR, Graham JD, et al. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol 2007, 8:475-487. for the RT01 collaborators.
14. Sydes MR, Stephens RJ, Moore AR, et al. Implementing the UK Medical Research Council (MRC) RT01 trial (ISRCTN 47772397): methods and practicalities of a randomised controlled trial of conformal radiotherapy in men with localised prostate cancer. Radiother Oncol 2004, 72:199-211.
15. Mayles WPM, Moore AR, Aird EGA, et al. Questionnaire based quality assurance for the RT01 trial of dose escalation in conformal radiotherapy for prostate cancer (ISRCTN 47772397). Radiother Oncol 2004, 73:199-207.
16. Vora SA, Wong WW, Schild SE, Ezzell GA, Halyard MY Analysis of biochemical control and prognostic factors in patients treated with either low-dose three-dimensional conformal radiation therapy or high-dose intensity-modulated radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys 2007, 68:1053-1058.
17. Van Poppel H, Collette L, Kirkali Z, et al. Quality control of radical prostatectomy: a feasibility study. Eur J Cancer 2001, 37:884-891.
18. Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology 2000, 56:899-905.
19. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993, 85:365-376.
20. Zigmond A, Snaith R The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67:361-370.
21. Gandek B, Ware JE, Aaronson NK, et al. Cross-validation of item selection and scoring for the SF-12 health survey in nine countries: results from the IQOLA project. J Clin Epidemiol 1998, 51:1171-1178.
22. Group E EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990, 16:199-208.
23. Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn 2004, 23:322-330.
24. Donovan J, Peters T, Abrams P, Brookes S, de la Rosette J, Schafer W Scoring the short form ICSmaleSF questionnaire (International Continence Society). J Urol 2000, 164:1948-1955.
25. Frankel SJ, Donovan JL, Peters TI, et al. Sexual dysfunction in men with lower urinary tract symptoms. J Clin Epidemiol 1998, 51:677-685.
26. Bauer P Multiple testing in clinical trials. Stat Med 1991, 10:871-890.
27. Hampson LV, Metcalfe C Incorporating prognostic factors into causal estimators: a comparison of methods for randomised controlled trials with a time-to-event outcome. Stat Med 2012, 31:3073-3088.
28. Loeys T, Goetghebeur E A causal proportional hazards estimator for the effect of treatment actually received in a randomized trial with all-or-nothing compliance. Biometrics 2003, 59:100-105.
29. Bul M, Zhu X, Rannikko A, et al. Radical prostatectomy for low-risk prostate cancer following initial active surveillance: results from a prospective observational study. Eur Urol 2012, 62:195-200.
30. Joniau S, Spahn M, Briganti A, et al. Pretreatment tables predicting pathologic stage of locally advanced prostate cancer. Eur Urol 2014, published online March 21. 10.1016/j.eururo.2014.03.013.
31. Warde P, Mason M, Ding K, et al. Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial. Lancet 2011, 378:2104-2111. for the NCIC CTG PR.3/MRC UK PR07 investigators.
32. Williams N, Hughes LJ, Turner EL, et al. Prostate-specific antigen testing rates remain low in UK general practice: a cross-sectional study in six English cities. BJU Int 2011, 108:1402-1408.
33. Moore AL, Dimitropoulou P, Lane A, et al. Population-based prostate-specific antigen testing in the UK leads to a stage migration of prostate cancer. BJU Int 2009, 104:1592-1598.
34. Greenberg DC, Wright KA, Lophathanon A, Muir KR, Gnanapragasam VJ Changing presentation of prostate cancer in a UK population-10 year trends in prostate cancer risk profiles in the East of England. Br J Cancer 2013, 109:2115-2120.
35. Donovan J, Mills N, Smith M, et al. Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult. BMJ 2002, 325:766-770.
36. Selley S, Donovan J, Faulkner A, Coast J, Gillatt D Diagnosis, management and screening of early localised prostate cancer: a review. Health Technol Assess 1997, 1:96.