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NCT02044172 · CITED IN SOURCE DOCUMENTS

Prostate Testing for Cancer and Treatment

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
NA
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2022-11-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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.
healthy Volunteers
true
maximum Age
69 Years
minimum Age
50 Years
sex
MALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Radical prostatectomy
    intervention Names
    1. Procedure: Radical prostatectomy
    label
    Radical prostatectomy
    type
    ACTIVE_COMPARATOR
  2. description
    Conformal radiation therapy External beam radiation therapy
    intervention Names
    1. Radiation: Conformal radiation therapy
    label
    Conformal radiation therapy
    type
    ACTIVE_COMPARATOR
  3. description
    Active monitoring of prostate specific antigen levels and disease surveillance
    intervention Names
    1. Other: Active monitoring
    label
    Active monitoring
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Radical prostatectomy
    description
    radical prostatectomy
    name
    Radical prostatectomy
    type
    PROCEDURE
  2. arm Group Labels
    1. Conformal radiation therapy
    description
    Conformal radiation therapy, external beam
    name
    Conformal radiation therapy
    type
    RADIATION
  3. arm Group Labels
    1. Active monitoring
    description
    Active monitoring of Prostate specific antigen levels and disease surveillance
    name
    Active monitoring
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
82849
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Disease specific mortality
    time Frame
    Median 15 years follow up
secondary Outcomes
  1. measure
    Overall survival
    time Frame
    Median 15 years
  2. description
    Metastases
    measure
    Disease progression
    time Frame
    Median 15 years
  3. measure
    Treatment complications
    time Frame
    Median 15 years
  4. measure
    General health status
    time Frame
    Median 15 years
  5. measure
    Psychological state
    time Frame
    Median 15 years
  6. measure
    Symptoms
    time Frame
    Median 15 years
  7. measure
    Sexual function
    time Frame
    Median 15years
Full study description
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.
Source references
references
  1. citation
    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
    21047592
    type
    BACKGROUND
  2. citation
    Sushentsev N, Warren AY, Colling R, Verrill C, Pazukhina E, Blyuss O, Zaikin A, Seibert TM, Barrett T, Oxley J, Mills IG, Bryant RJ, Lane JA, Donovan JL, Neal DE, Hamdy FC. Long-term outcomes of cribriform-positive and cribriform-negative prostate cancer treated with radical prostatectomy in the ProtecT trial. BJU Int. 2026 Jun;137(6):984-991. doi: 10.1111/bju.70261. Epub 2026 Mar 27.
    pmid
    41896701
    type
    DERIVED
  3. citation
    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
    41100113
    type
    DERIVED
  4. citation
    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
    38320051
    type
    DERIVED
  5. citation
    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
    36912538
    type
    DERIVED
  6. citation
    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
    33028256
    type
    DERIVED
  7. citation
    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
    32669672
    type
    DERIVED
  8. citation
    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
    31170515
    type
    DERIVED
  9. citation
    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
    29288137
    type
    DERIVED
  10. citation
    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
    29084797
    type
    DERIVED
  11. citation
    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
    27626365
    type
    DERIVED
  12. citation
    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
    27626136
    type
    DERIVED
see Also Links
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        therapy reserved for signs of tumor progression. This has been shown most clearly in the large Prostate Testing for Cancer Treatment (<a href="/clinicaltrials/NCT02044172">ProtecT</a> [NCT02044172 and ISRCTN20141297]) randomized trial that compared active monitoring, radical prostatectomy, and radiation therapy.[<a href="#cit/se
        end
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        NCT02044172
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      2. context exact
        s of tumor progression. This has been shown most clearly in the large Prostate Testing for Cancer Treatment (<a href="/clinicaltrials/NCT02044172">ProtecT</a> [NCT02044172 and ISRCTN20141297]) randomized trial that compared active monitoring, radical prostatectomy, and radiation therapy.[<a href="#cit/section_3.19">19</a>] For mo
        end
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      3. context exact
        ere worse with surgery than with observation through 2 years, but then were similar in both study arms.</li></ul></div></li><li>In the <a href="/clinicaltrials/NCT02044172">ProtecT</a> trial (NCT02044172 and ISRCTN20141297), 82,429 men were screened with PSA testing, and 2,664 were diagnosed with clinically localized prostate can
        end
        153997
        exact text
        NCT02044172
        start
        153986
      4. context exact
        observation through 2 years, but then were similar in both study arms.</li></ul></div></li><li>In the <a href="/clinicaltrials/NCT02044172">ProtecT</a> trial (NCT02044172 and ISRCTN20141297), 82,429 men were screened with PSA testing, and 2,664 were diagnosed with clinically localized prostate cancer. Among those diagnosed, 1,64
        end
        154029
        exact text
        NCT02044172
        start
        154018
      5. context exact
        ere worse with surgery than with observation through 2 years, but then were similar in both study arms.</li></ul></div></li><li>In the <a href="/clinicaltrials/NCT02044172">ProtecT</a> trial (NCT02044172 and ISRCTN20141297), 82,429 men were screened with PSA testing, and 2,664 were diagnosed with clinically localized prostate can
        end
        330815
        exact text
        NCT02044172
        start
        330804
      6. context exact
        observation through 2 years, but then were similar in both study arms.</li></ul></div></li><li>In the <a href="/clinicaltrials/NCT02044172">ProtecT</a> trial (NCT02044172 and ISRCTN20141297), 82,429 men were screened with PSA testing, and 2,664 were diagnosed with clinically localized prostate cancer. Among those diagnosed, 1,6
        end
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      source title
      Prostate Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice