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NCT00003290 · CITED IN SOURCE DOCUMENTS

Radiation Therapy in Treating Patients With Prostate Cancer

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

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2013-12-04

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether standard radiation therapy is more effective than high-dose radiation therapy in treating patients with prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with that of high-dose radiation therapy in treating patients with stage II or stage III 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
DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * T1b-T3a, N0, M0 (stage II or III) * Prostate-specific antigen at least 50 ng/mL PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 4,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 11 g/dL Hepatic: * Not specified Renal: * Not specified Other: * No significant past medical history that would preclude radical radiotherapy * No condition that would preclude standard radiotherapy * No hip prosthesis PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No prior androgen deprivation therapy Radiotherapy: * No prior pelvic radiotherapy Surgery: * No prior radical prostatectomy
healthy Volunteers
false
sex
MALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    gonadotrophin releasing hormone
    type
    BIOLOGICAL
  2. name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
800
type
ESTIMATED
Registered outcome plans (not posted results)
Full study description
brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether standard radiation therapy is more effective than high-dose radiation therapy in treating patients with prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with that of high-dose radiation therapy in treating patients with stage II or stage III prostate cancer.
detailed Description
OBJECTIVES: * Compare local tumor control in patients with stage II or III prostate cancer treated with neoadjuvant androgen deprivation therapy with standard vs high-dose conformal radiotherapy. * Compare the incidence of biochemical failure (prostate-specific antigen (PSA) greater than 2 ng/mL at 6 or more months after initiation of radiotherapy and PSA rising from nadir level by at least 50%), development of metastases, and survival in patients treated with these regimens. * Compare the acute and late radiation-induced side effects of these regimens in this patient population. * Compare aspects of quality of life, health economics, models of normal tissue, and tumor control in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen, T stage, and Gleason score. Patients are randomized to one of two treatment arms. All patients receive neoadjuvant androgen deprivation with luteinizing hormone-releasing hormone agonists every 4 weeks beginning 3-6 months before initiation of radiotherapy and continuing until completion of radiotherapy. * Arm I: Patients undergo standard conformal radiotherapy for 6.5 weeks. * Arm II: Patients undergo high-dose conformal radiotherapy for 7.5 weeks. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually thereafter. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.
Source references
references
  1. citation
    South CP, Khoo VS, Naismith O, Norman A, Dearnaley DP. A comparison of treatment planning techniques used in two randomised UK external beam radiotherapy trials for localised prostate cancer. Clin Oncol (R Coll Radiol). 2008 Feb;20(1):15-21. doi: 10.1016/j.clon.2007.10.012. Epub 2007 Dec 3.
    pmid
    18054471
    type
    BACKGROUND
  2. citation
    van As N, South C, Naismith O, et al.: Radiotherapy planning in UK phase III trials of dose-escalated (MRC RT01) and high-dose hypofractionated radiotherapy (CHHIP) in prostate cancer. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-98, 2006.
    type
    BACKGROUND
  3. citation
    Mayles WP, Moore AR, Aird EG, Bidmead AM, Dearnaley DP, Griffiths SE, Warrington AP; RT01 collaborators. Questionnaire based quality assurance for the RT01 trial of dose escalation in conformal radiotherapy for prostate cancer (ISRCTN 47772397). Radiother Oncol. 2004 Nov;73(2):199-207. doi: 10.1016/j.radonc.2004.08.017.
    pmid
    15622611
    type
    BACKGROUND
  4. citation
    Sydes MR, Stephens RJ, Moore AR, Aird EG, Bidmead AM, Fallowfield LJ, Graham J, Griffiths S, Mayles WP, McGuire A, Stanley S, Warrington AP, Dearnaley DP; RT01 collaborators. 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 Aug;72(2):199-211. doi: 10.1016/j.radonc.2004.04.007.
    pmid
    15297138
    type
    BACKGROUND
  5. citation
    Gulliford SL, Partridge M, Sydes MR, Webb S, Evans PM, Dearnaley DP. Parameters for the Lyman Kutcher Burman (LKB) model of Normal Tissue Complication Probability (NTCP) for specific rectal complications observed in clinical practise. Radiother Oncol. 2012 Mar;102(3):347-51. doi: 10.1016/j.radonc.2011.10.022. Epub 2011 Nov 25.
    pmid
    22119373
    type
    RESULT
  6. citation
    Barnett GC, De Meerleer G, Gulliford SL, Sydes MR, Elliott RM, Dearnaley DP. The impact of clinical factors on the development of late radiation toxicity: results from the Medical Research Council RT01 trial (ISRCTN47772397). Clin Oncol (R Coll Radiol). 2011 Nov;23(9):613-24. doi: 10.1016/j.clon.2011.03.001. Epub 2011 Apr 5.
    pmid
    21470834
    type
    RESULT
  7. citation
    Gulliford SL, Foo K, Morgan RC, Aird EG, Bidmead AM, Critchley H, Evans PM, Gianolini S, Mayles WP, Moore AR, Sanchez-Nieto B, Partridge M, Sydes MR, Webb S, Dearnaley DP. Dose-volume constraints to reduce rectal side effects from prostate radiotherapy: evidence from MRC RT01 Trial ISRCTN 47772397. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):747-54. doi: 10.1016/j.ijrobp.2009.02.025. Epub 2009 Jun 18.
    pmid
    19540054
    type
    RESULT
  8. citation
    Syndikus I, Morgan RC, Sydes MR, Graham JD, Dearnaley DP; MRC RT01 collaborators. Late gastrointestinal toxicity after dose-escalated conformal radiotherapy for early prostate cancer: results from the UK Medical Research Council RT01 trial (ISRCTN47772397). Int J Radiat Oncol Biol Phys. 2010 Jul 1;77(3):773-83. doi: 10.1016/j.ijrobp.2009.05.052. Epub 2009 Oct 14.
    pmid
    19836155
    type
    RESULT
  9. citation
    Stanley S, Griffiths S, Sydes MR, Moore AR, Syndikus I, Dearnaley DP; RT01 Radiographer Trial Implementation Group. Accuracy and reproducibility of conformal radiotherapy using data from a randomised controlled trial of conformal radiotherapy in prostate cancer (MRC RT01, ISRCTN47772397). Clin Oncol (R Coll Radiol). 2008 Oct;20(8):582-90. doi: 10.1016/j.clon.2008.04.019. Epub 2008 Jun 18.
    pmid
    18565744
    type
    RESULT
  10. citation
    Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2.
    pmid
    17482880
    type
    RESULT
  11. citation
    Dearnaley DP, Sydes MR, Langley RE, Graham JD, Huddart RA, Syndikus I, Matthews JH, Scrase CD, Jose CC, Logue J, Stephens RJ; RT01 Collaborators. The early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: results from the MRC RT01 trial (ISRCTN47772397). Radiother Oncol. 2007 Apr;83(1):31-41. doi: 10.1016/j.radonc.2007.02.014. Epub 2007 Mar 27.
    pmid
    17391791
    type
    RESULT
  12. citation
    Mangar SA, Sydes MR, Tucker HL, Coffey J, Sohaib SA, Gianolini S, Webb S, Khoo VS; MRC RT01 Trial Management Group; Dearnaley DP. Evaluating the relationship between erectile dysfunction and dose received by the penile bulb: using data from a randomised controlled trial of conformal radiotherapy in prostate cancer (MRC RT01, ISRCTN47772397). Radiother Oncol. 2006 Sep;80(3):355-62. doi: 10.1016/j.radonc.2006.07.037. Epub 2006 Sep 1.
    pmid
    16949694
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        cause-specific survival benefit to higher doses. <div class="pdq-content-list"><ul id="_2206"><li>The <a href="/clinicaltrials/NCT00003290">MRC-RT01</a> study (NCT00003290) enrolled 843 men with stage T1b through T3a, N0, M0 prostate cancer. Patients were randomly assigned to receive 64 Gy in 32 fractions versus 74 Gy in 37 fract
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      source title
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      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