NCT02044172

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82,849

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
10mo left

Started Jun 2001

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jun 2001Mar 2027

Study Start

First participant enrolled

June 1, 2001

Completed
12.6 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2020

Completed
6.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

19.5 years

First QC Date

January 21, 2014

Last Update Submit

November 8, 2022

Conditions

Prostate Cancer

Keywords

Prostate cancerTreatmentScreeningSurgeryRadiotherapyActive monitoring

Outcome Measures

Primary Outcomes (1)

  • Disease specific mortality

    Median 15 years follow up

Secondary Outcomes (7)

  • Overall survival

    Median 15 years

  • Disease progression

    Median 15 years

  • Treatment complications

    Median 15 years

  • General health status

    Median 15 years

  • Psychological state

    Median 15 years

  • +2 more secondary outcomes

Study Arms (3)

Radical prostatectomy

ACTIVE COMPARATOR

Radical prostatectomy

Procedure: Radical prostatectomy

Conformal radiation therapy

ACTIVE COMPARATOR

Conformal radiation therapy External beam radiation therapy

Radiation: Conformal radiation therapy

Active monitoring

ACTIVE COMPARATOR

Active monitoring of prostate specific antigen levels and disease surveillance

Other: Active monitoring

Interventions

Radical prostatectomyPROCEDURE

radical prostatectomy

Radical prostatectomy
Conformal radiation therapyRADIATION

Conformal radiation therapy, external beam

Conformal radiation therapy
Active monitoringOTHER

Active monitoring of Prostate specific antigen levels and disease surveillance

Active monitoring

Eligibility Criteria

Age50 Years - 69 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Southmead Hospital

Bristol, United Kingdom

Location

Addenbrokes' Hospital

Cambridge, United Kingdom

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

Western General Hospital

Edinburgh, United Kingdom

Location

Leicester General Hospital

Leicester, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

Related Publications (16)

  • 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.

    PMID: 21047592BACKGROUND

  • Sushentsev N, Warren AY, Colling R, Verrill C, Pazukhina E, Blyuss O, Seibert TM, Barrett T, Mills IG, Bryant RJ, Donovan JL, Neal DE, Hamdy FC. Active Monitoring, Surgery, and Radiotherapy for Cribriform-Positive and Cribriform-Negative Prostate Cancer: A Secondary Analysis of the PROTECT Randomized Clinical Trial. JAMA Oncol. 2025 Dec 1;11(12):1512-1517. doi: 10.1001/jamaoncol.2025.4125.

    PMID: 41100113DERIVED

  • Donovan JL, Hamdy FC, Lane JA, Young GJ, Metcalfe C, Walsh EI, Davis M, Steuart-Feilding T, Blazeby JM, Avery KNL, Martin RM, Bollina P, Doble A, Doherty A, Gillatt D, Gnanapragasam V, Hughes O, Kockelbergh R, Kynaston H, Paul A, Paez E, Powell P, Rosario DJ, Rowe E, Mason M, Catto JWF, Peters TJ, Wade J, Turner EL, Williams NJ, Oxley J, Staffurth J, Bryant RJ, Neal DE. Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment. NEJM Evid. 2023 Apr;2(4):EVIDoa2300018. doi: 10.1056/EVIDoa2300018. Epub 2023 Mar 11.

    PMID: 38320051DERIVED

  • Hamdy FC, Donovan JL, Lane JA, Metcalfe C, Davis M, Turner EL, Martin RM, Young GJ, Walsh EI, Bryant RJ, Bollina P, Doble A, Doherty A, Gillatt D, Gnanapragasam V, Hughes O, Kockelbergh R, Kynaston H, Paul A, Paez E, Powell P, Rosario DJ, Rowe E, Mason M, Catto JWF, Peters TJ, Oxley J, Williams NJ, Staffurth J, Neal DE; ProtecT Study Group. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2023 Apr 27;388(17):1547-1558. doi: 10.1056/NEJMoa2214122. Epub 2023 Mar 11.

    PMID: 36912538DERIVED

  • 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.

    PMID: 33028256DERIVED

  • 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.

    PMID: 32669672DERIVED

  • 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.

    PMID: 31170515DERIVED

  • 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.

    PMID: 29288137DERIVED

  • 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.

    PMID: 29084797DERIVED

  • 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.

    PMID: 27626365DERIVED

  • 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.

    PMID: 27626136DERIVED

  • 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.

    PMID: 26384727DERIVED

  • 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.

    PMID: 25595936DERIVED

  • 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.

    PMID: 25231130DERIVED

  • 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.

    PMID: 25163905DERIVED

  • 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.

    PMID: 23411385DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Freddie C Hamdy

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 23, 2014

Study Start

June 1, 2001

Primary Completion

November 14, 2020

Study Completion (Estimated)

March 31, 2027

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

GB(8)