Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RT01
Study information
Scientific title
High dose therapy in localised cancer of the prostate using conformal radiotherapy techniques
Acronym
Study hypothesis
To compare standard 64 Gy dose of conformal radiotherapy (CRT) with high dose 74 Gy CRT
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cancer
Intervention
1. Standard 64 Gy dose of conformal radiotherapy (CRT)
2. The other group receives high dose 74 Gy CRT
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Local tumour control, incidence of biochemical failure, metastases, survival, side effects of radiation, quality of life and health economic resources
Secondary outcome measures
Not provided at time of registration
Overall trial start date
05/01/1998
Overall trial end date
31/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Cancer of the prostate T1b-T3a, N0, M0
2. Prostate-Specific Antigen (PSA) less than 50 ng/ml
3. World Health Organisation (WHO) 0 or 1
4. No prior radiotherapy or prostatectomy
5. No previous androgen deprivation
6. No hip prosthesis or other condition precluding radiotherapy
7. Written informed consent
Participant type
Patient
Age group
Other
Gender
Male
Target number of participants
843
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
05/01/1998
Recruitment end date
31/12/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15297138
2. 2004 questionnaire in http://www.ncbi.nlm.nih.gov/pubmed/15622611
3. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16828908
4. 2006 results on erectile dysfunction and radiotherapy in http://www.ncbi.nlm.nih.gov/pubmed/16949694
5. 2007 results on quality of life in http://www.ncbi.nlm.nih.gov/pubmed/17155990
6. 2007 results on early toxicity of escalated Vs standard dose conformal radiotherapy in http://www.ncbi.nlm.nih.gov/pubmed/17391791
7. 2007 results on escalated Vs standard dose conformal radiotherapy in http://www.ncbi.nlm.nih.gov/pubmed/17482880
8. 2009 results on dose-volume constraints to reduce rectal side effects in http://www.ncbi.nlm.nih.gov/pubmed/19540054
9. 2009 results on correlations between spatial distribution of the dose to the rectal wall and late rectal toxicity in http://www.ncbi.nlm.nih.gov/pubmed/19826203
10. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20443499
11. 2011 modellin late rectal toxicities results in http://www.ncbi.nlm.nih.gov/pubmed/21386140
12. 2011 additional rectal toxicity endpoint results in http://www.ncbi.nlm.nih.gov/pubmed/22119373
13. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21470834
14. 2012 prospective analysis study in http://www.ncbi.nlm.nih.gov/pubmed/22169268
15. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22520267
16. 2014 long-term results in http://www.ncbi.nlm.nih.gov/pubmed/24581940
17. 2017 secondary data analysis in: https://www.ncbi.nlm.nih.gov/pubmed/28352980
18. 2018 two-years postradiotherapy biopsies results in: https://www.ncbi.nlm.nih.gov/pubmed/29307509 [added 15/03/2019]
Publication citations
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Results on escalated Vs standard dose conformal radiotherapy
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, , Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial., Lancet Oncol., 2007, 8, 6, 475-487, doi: 10.1016/S1470-2045(07)70143-2.
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Results on correlations between spatial distribution of the dose to the rectal wall and late rectal toxicity
Buettner F, Gulliford SL, Webb S, Sydes MR, Dearnaley DP, Partridge M, Assessing correlations between the spatial distribution of the dose to the rectal wall and late rectal toxicity after prostate radiotherapy: an analysis of data from the MRC RT01 trial (ISRCTN 47772397)., Phys Med Biol, 2009, 54, 21, 6535-6548, doi: 10.1088/0031-9155/54/21/006.
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Results
Buettner F, Gulliford SL, Webb S, Partridge M, Using Bayesian logistic regression to evaluate a new type of dosimetric constraint for prostate radiotherapy treatment planning., Med Phys, 2010, 37, 4, 1768-1777.
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Modellin late rectal toxicities results
Buettner F, Gulliford SL, Webb S, Partridge M, Modeling late rectal toxicities based on a parameterized representation of the 3D dose distribution., Phys Med Biol, 2011, 56, 7, 2103-2118, doi: 10.1088/0031-9155/56/7/013.
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Additional rectal toxicity endpoint results
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, 102, 3, 347-351, doi: 10.1016/j.radonc.2011.10.022.
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Prospective analysis study
Barnett GC, Coles CE, Elliott RM, Baynes C, Luccarini C, Conroy D, Wilkinson JS, Tyrer J, Misra V, Platte R, Gulliford SL, Sydes MR, Hall E, Bentzen SM, Dearnaley DP, Burnet NG, Pharoah PD, Dunning AM, West CM, Independent validation of genes and polymorphisms reported to be associated with radiation toxicity: a prospective analysis study., Lancet Oncol., 2012, 13, 1, 65-77, doi: 10.1016/S1470-2045(11)70302-3.
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Results
Buettner F, Gulliford SL, Webb S, Sydes MR, Dearnaley DP, Partridge M, The dose-response of the anal sphincter region--an analysis of data from the MRC RT01 trial., Radiother Oncol, 2012, 103, 3, 347-352, doi: 10.1016/j.radonc.2012.03.002.
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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, , 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, 72, 2, 199-211, doi: 10.1016/j.radonc.2004.04.007.
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Mayles WP, Moore AR, Aird EG, Bidmead AM, Dearnaley DP, Griffiths SE, Warrington AP, , Questionnaire based quality assurance for the RT01 trial of dose escalation in conformal radiotherapy for prostate cancer (ISRCTN 47772397)., Radiother Oncol, 2004, 73, 2, 199-207.
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Moore AR, Warrington AP, Aird EG, Bidmead AM, Dearnaley DP, A versatile phantom for quality assurance in the UK Medical Research Council (MRC) RT01 trial (ISRCTN47772397) in conformal radiotherapy for prostate cancer., Radiother Oncol, 2006, 80, 1, 82-85, doi: 10.1016/j.radonc.2006.06.003.
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Mangar SA, Sydes MR, Tucker HL, Coffey J, Sohaib SA, Gianolini S, Webb S, Khoo VS, , 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, 80, 3, 355-362, doi: 10.1016/j.radonc.2006.07.037.
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Stephens RJ, Dearnaley DP, Cowan R, Sydes M, Naylor S, Fallowfield L, , The quality of life of men with locally advanced prostate cancer during neoadjuvant hormone therapy: data from the Medical Research Council RT01 trial (ISRCTN 47772397)., BJU Int., 2007, 99, 2, 301-310, doi: 10.1111/j.1464-410X.2006.06560.x.
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Dearnaley DP, Sydes MR, Langley RE, Graham JD, Huddart RA, Syndikus I, Matthews JH, Scrase CD, Jose CC, Logue J, Stephens RJ, , 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, 83, 1, 31-41, doi: 10.1016/j.radonc.2007.02.014.
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Gulliford SL, Foo K, Morgan RC, Aird EG, Bidmead AM, Critchley H, Evans PM, Gianolini S, Mayles WP, Moore AR, Sánchez-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, 76, 3, 747-754, doi: 10.1016/j.ijrobp.2009.02.025.
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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, 23, 9, 613-624, doi: 10.1016/j.clon.2011.03.001.
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Dearnaley DP, Jovic G, Syndikus I, Khoo V, Cowan RA, Graham JD, Aird EG, Bottomley D, Huddart RA, Jose CC, Matthews JH, Millar JL, Murphy C, Russell JM, Scrase CD, Parmar MK, Sydes MR, Escalated-dose versus control-dose conformal radiotherapy for prostate cancer: long-term results from the MRC RT01 randomised controlled trial., Lancet Oncol., 2014, 15, 4, 464-473, doi: 10.1016/S1470-2045(14)70040-3.