Prostate Testing for Cancer and Treatment (ProtecT)

• ClinicalTrials.gov Identifier: NCT02044172
• Recruitment Status: Active, not recruiting
• First Posted: January 23, 2014
• Last Update Posted: November 14, 2022
• Sponsor: University of Oxford
• Collaborator: University of Bristol
• Information provided by (Responsible Party): University of Oxford

Tracking Information

• First Submitted Date: January 21, 2014
• First Posted Date: January 23, 2014
• Last Update Posted Date: November 14, 2022
• Actual Study Start Date: June 1, 2001
• Actual Primary Completion Date: November 14, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 19, 2020): Disease specific mortality [ Time Frame: Median 15 years follow up ]
• Original Primary Outcome Measures (submitted: January 21, 2014): Disease specific mortality [ Time Frame: Median 10 years follow up ]

Current Secondary Outcome Measures (submitted: June 19, 2020)

• Overall survival [ Time Frame: Median 15 years ]
• Disease progression [ Time Frame: Median 15 years ]
  Metastases
• Treatment complications [ Time Frame: Median 15 years ]
• General health status [ Time Frame: Median 15 years ]
• Psychological state [ Time Frame: Median 15 years ]
• Symptoms [ Time Frame: Median 15 years ]
• Sexual function [ Time Frame: Median 15years ]

Original Secondary Outcome Measures (submitted: January 21, 2014)

• Overall survival [ Time Frame: Median 10 years ]
• Disease progression [ Time Frame: Median 10 years ]
  Metastases
• Treatment complications [ Time Frame: Median 10 years ]
• General health status [ Time Frame: Median 10 years ]
• Psychological state [ Time Frame: Median 10 years ]
• Symptoms [ Time Frame: Median 10 years ]
• Sexual function [ Time Frame: Median 10 years ]
• Resource use [ Time Frame: Median 10 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prostate Testing for Cancer and Treatment
• Official Title: The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer

Brief Summary

RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor may not need treatment until it progresses. In this case, active surveillance may be sufficient. It is not yet known which treatment regimen is more effective for localized prostate cancer.

PURPOSE: This randomized phase III trial is studying active monitoring to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.

Detailed Description

OBJECTIVES:

• To assess survival of patients with localized prostate cancer at 10 years and 15 years after treatment.
• To investigate disease progression (i.e., biochemical and clinical), treatment complications, and lower urinary tract symptoms in these patients.
• To investigate the psychosocial impact of cancer detection and treatment on these patients, including generic health status, quality of life, and sexual function.
• To estimate the resource use and costs of detection, treatment, and follow-up.
• To compare costs and outcomes of treatment in terms of survival and health-related quality of life.
• To collect samples suitable for basic science research (ProMPT study).

OUTLINE: This is a multicenter study. Patients are stratified by age (50-55 vs 56-59 vs 60-65 vs 66-69 years), Gleason score (6, 7, 8-10), and average result of recruitment and first biopsy prostate-specific antigen (PSA) tests (< 6 vs 6-9.9 vs ≥ 10 ng/mL). Patients are randomized or select a treatment to be followed up in a cohort study.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

• Procedure: Radical prostatectomy
  radical prostatectomy
• Radiation: Conformal radiation therapy
  Conformal radiation therapy, external beam
• Other: Active monitoring
  Active monitoring of Prostate specific antigen levels and disease surveillance

Study Arms

• Active Comparator: Radical prostatectomy
  Radical prostatectomy
  Intervention: Procedure: Radical prostatectomy
• Active Comparator: Conformal radiation therapy
  Conformal radiation therapy External beam radiation therapy
  Intervention: Radiation: Conformal radiation therapy
• Active Comparator: Active monitoring
  Active monitoring of prostate specific antigen levels and disease surveillance
  Intervention: Other: Active monitoring

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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 8, 2022): 82849
• Original Actual Enrollment (submitted: January 21, 2014): 100000
• Estimated Study Completion Date: March 31, 2027
• Actual Primary Completion Date: November 14, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Fit for the treatments and estimates life expectancy of 10 years Registration with eligible primary care practice

Exclusion Criteria:

Unable to give written informed consent. Concomitant or past malignancy.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 50 Years to 69 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02044172
• Other Study ID Numbers: HTA96/20/99; 20141297 ( Registry Identifier: ISRCTN )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Oxford
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Oxford
• Original Study Sponsor: Same as current
• Collaborators: University of Bristol

Investigators

• Principal Investigator: Freddie C Hamdy; University of Oxford

• PRS Account: University of Oxford
• Verification Date: November 2022