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High dose therapy in localised cancer of the prostate using conformal radiotherapy techniques
ISRCTN ISRCTN47772397
DOI 10.1186/ISRCTN47772397
ClinicalTrials.gov identifier
EudraCT number
Public title High dose therapy in localised cancer of the prostate using conformal radiotherapy techniques
Scientific title
Acronym N/A
Serial number at source RT01
Study hypothesis To compare standard 64 Gy dose of conformal radiotherapy (CRT) with high dose 74 Gy CRT
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cancer
Participants - 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
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 05/01/1998
Anticipated end date 31/12/2001
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 843
Interventions 1. Standard 64 Gy dose of conformal radiotherapy (CRT)
2. The other group receives high dose 74 Gy CRT
Primary outcome measure(s) Local tumour control, incidence of biochemical failure, metastases, survival, side effects of radiation, quality of life and health economic resources
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Medical Research Council (MRC) (UK)
Trial website
Publications 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
Contact name Mr  Matthew  Sydes
  Address MRC Clinical Trials Unit
Cancer Division
222 Euston Road
  City/town London
  Zip/Postcode NW1 2DA
  Country United Kingdom
Sponsor Medical Research Council (MRC) (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Fax +44 (0)20 7436 6179
  Email clinical.trial@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 06/04/2000
Last edited 05/03/2014
Date ISRCTN assigned 06/04/2000
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