Prostate Testing for Cancer and Treatment (ProtecT)

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ClinicalTrials.gov Identifier: NCT02044172

Recruitment Status : Active, not recruiting

First Posted : January 23, 2014

Last Update Posted : November 14, 2022

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

University of Bristol

Information provided by (Responsible Party):

University of Oxford

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Active, not recruiting
Actual Primary Completion Date :	November 14, 2020
Estimated Study Completion Date :	March 31, 2027

Publications:

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 Nov;46(17):3095-101. doi: 10.1016/j.ejca.2010.09.016.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sanghera S, Mohiuddin S, Coast J, Garfield K, Noble S, Metcalfe C, Lane JA, Turner EL, Neal D, Hamdy FC, Martin RM, Donovan JL; ProtecT study group. Modelling the lifetime cost-effectiveness of radical prostatectomy, radiotherapy and active monitoring for men with clinically localised prostate cancer from median 10-year outcomes in the ProtecT randomised trial. BMC Cancer. 2020 Oct 7;20(1):971. doi: 10.1186/s12885-020-07276-4.

Noble SM, Garfield K, Lane JA, Metcalfe C, Davis M, Walsh EI, Martin RM, Turner EL, Peters TJ, Thorn JC, Mason M, Bollina P, Catto JWF, Doherty A, Gnanapragasam V, Hughes O, Kockelbergh R, Kynaston H, Paul A, Paez E, Rosario DJ, Rowe E, Oxley J, Staffurth J, Neal DE, Hamdy FC, Donovan JL. The ProtecT randomised trial cost-effectiveness analysis comparing active monitoring, surgery, or radiotherapy for prostate cancer. Br J Cancer. 2020 Sep;123(7):1063-1070. doi: 10.1038/s41416-020-0978-4. Epub 2020 Jul 16.

Donovan JL, Opmeer B, Young GJ, Mills N, Martin RM, Lane JA, Metcalfe C, Peters TJ, Davis M, Turner EL, Walsh E, Neal DE, Hamdy FC; ProtecT Study Group. Factors associated with trial recruitment, preferences, and treatments received were elucidated in a comprehensive cohort study. J Clin Epidemiol. 2019 Sep;113:200-213. doi: 10.1016/j.jclinepi.2019.05.036. Epub 2019 Jun 3.

Donovan JL, Young GJ, Walsh EI, Metcalfe C, Lane JA, Martin RM, Tazewell MK, Davis M, Peters TJ, Turner EL, Mills N, Khazragui H, Khera TK, Neal DE, Hamdy FC; ProtecT Study Group. A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial: the ProtecT prostate cancer trial. J Clin Epidemiol. 2018 Apr;96:35-46. doi: 10.1016/j.jclinepi.2017.12.019. Epub 2017 Dec 27.

Young GJ, Harrison S, Turner EL, Walsh EI, Oliver SE, Ben-Shlomo Y, Evans S, Lane JA, Neal DE, Hamdy FC, Donovan JL, Martin RM, Metcalfe C. Prostate-specific antigen (PSA) testing of men in UK general practice: a 10-year longitudinal cohort study. BMJ Open. 2017 Oct 30;7(10):e017729. doi: 10.1136/bmjopen-2017-017729.

Donovan JL, Hamdy FC, Lane JA, Mason M, Metcalfe C, Walsh E, Blazeby JM, Peters TJ, Holding P, Bonnington S, Lennon T, Bradshaw L, Cooper D, Herbert P, Howson J, Jones A, Lyons N, Salter E, Thompson P, Tidball S, Blaikie J, Gray C, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Davis M, Turner EL, Martin RM, Neal DE; ProtecT Study Group*. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1425-1437. doi: 10.1056/NEJMoa1606221. Epub 2016 Sep 14. Erratum In: N Engl J Med. 2023 Jun 8;388(23):2208.

Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.

Wade J, Holding PN, Bonnington S, Rooshenas L, Lane JA, Salter CE, Tilling K, Speakman MJ, Brewster SF, Evans S, Neal DE, Hamdy FC, Donovan JL; ProtecT Study Group. Establishing nurse-led active surveillance for men with localised prostate cancer: development and formative evaluation of a model of care in the ProtecT trial. BMJ Open. 2015 Sep 18;5(9):e008953. doi: 10.1136/bmjopen-2015-008953.

Kote-Jarai Z, Mikropoulos C, Leongamornlert DA, Dadaev T, Tymrakiewicz M, Saunders EJ, Jones M, Jugurnauth-Little S, Govindasami K, Guy M, Hamdy FC, Donovan JL, Neal DE, Lane JA, Dearnaley D, Wilkinson RA, Sawyer EJ, Morgan A, Antoniou AC, Eeles RA; UK Genetic Prostate Cancer Study Collaborators, and the ProtecT Study Group. Prevalence of the HOXB13 G84E germline mutation in British men and correlation with prostate cancer risk, tumour characteristics and clinical outcomes. Ann Oncol. 2015 Apr;26(4):756-761. doi: 10.1093/annonc/mdv004. Epub 2015 Jan 16.

Lane JA, Donovan JL, Davis M, Walsh E, Dedman D, Down L, Turner EL, Mason MD, Metcalfe C, Peters TJ, Martin RM, Neal DE, Hamdy FC; ProtecT study group. Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial. Lancet Oncol. 2014 Sep;15(10):1109-18. doi: 10.1016/S1470-2045(14)70361-4. Epub 2014 Aug 19. Erratum In: Lancet Oncol. 2014 Oct;15(11):e475.

Oxley J, Simpkin A, Goepel J, Varma M, Griffiths D, Grigor K, Mayer N, Warren A, Deshmukh N, Bhattarai S, Dormer J, Hounsome L, Adamczyk LA, Metcalfe C, Lane JA, Davis M, Donovan JL, Neal DE, Hamdy FC, Robinson MC; ProtecT Study Group. Gleason drift in the NIHR ProtecT study. Histopathology. 2015 Feb;66(3):438-46. doi: 10.1111/his.12549. Epub 2015 Jan 7.

Fung-Kee-Fung SD, Porten SP, Meng MV, Kuettel M. The role of active surveillance in the management of prostate cancer. J Natl Compr Canc Netw. 2013 Feb 1;11(2):183-7. doi: 10.6004/jnccn.2013.0026.

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