Radiation Therapy in Treating Patients With Prostate Cancer
NCT ID: NCT00003290
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
800 participants
INTERVENTIONAL
1998-01-31
2004-08-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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gonadotrophin releasing hormone
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
MALE
No
Sponsors
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Medical Research Council
OTHER_GOV
Principal Investigators
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David P. Dearnaley, MD, FRCP, FRCR
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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Groote Schuur Hospital, Cape Town
Cape Town, , South Africa
University of Birmingham
Birmingham, England, United Kingdom
Bristol Royal Hospital for Children
Bristol, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Cookridge Hospital
Leeds, England, United Kingdom
University Hospitals of Leicester
Leicester, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Mount Vernon Hospital
Northwood, England, United Kingdom
Norfolk & Norwich Hospital
Norwich, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom
Southend NHS Trust Hospital
Westcliff-on-Sea, England, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Dearnaley DP, Hall E, Lawrence D, Huddart RA, Eeles R, Nutting CM, Gadd J, Warrington A, Bidmead M, Horwich A. Phase III pilot study of dose escalation using conformal radiotherapy in prostate cancer: PSA control and side effects. Br J Cancer. 2005 Feb 14;92(3):488-98. doi: 10.1038/sj.bjc.6602301.
Stephen M, Helen T, Matthew S, et al.: Evaluating the relationship between erectile dysfunction and dose received by the penile bulb in patients undergoing conformal radiotherapy for prostate cancer: analysis of data from the MRC RT01 dose escalation trial (ISRCTN47772397). [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-209, S126, 2005.
Stephens RJ, Cowan R, Dearnaley DP, et al.: The effect of hormone therapy on the quality of life of men with locally advanced prostate cancer (based on data from the MRC RT01 randomised trial (ISRCTN 47772397)). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1665, 414, 2003.
Seddon B, Bidmead M, Wilson J, Khoo V, Dearnaley D. Target volume definition in conformal radiotherapy for prostate cancer: quality assurance in the MRC RT-01 trial. Radiother Oncol. 2000 Jul;56(1):73-83. doi: 10.1016/s0167-8140(00)00191-2.
Other Identifiers
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MRC-RT01
Identifier Type: -
Identifier Source: secondary_id
EU-98005
Identifier Type: -
Identifier Source: secondary_id
CDR0000066222
Identifier Type: -
Identifier Source: org_study_id