Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
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 study start date
05/01/1998
Overall study 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(s)
Patient
Age group
Other
Sex
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
England, United Kingdom
Study 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)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Protocol article | protocol | 01/08/2004 | Yes | No | |
| Other publications | questionnaire | 01/11/2004 | Yes | No | |
| Protocol article | protocol | 01/07/2006 | Yes | No | |
| Results article | results on erectile dysfunction and radiotherapy | 01/09/2006 | Yes | No | |
| Results article | results on quality of life | 01/02/2007 | Yes | No | |
| Results article | results on early toxicity of escalated Vs standard dose conformal radiotherapy | 01/04/2007 | Yes | No | |
| Results article | results on escalated Vs standard dose conformal radiotherapy | 01/06/2007 | Yes | No | |
| Results article | results on correlations between spatial distribution of the dose to the rectal wall and late rectal toxicity | 07/11/2009 | Yes | No | |
| Results article | results on dose-volume constraints to reduce rectal side effects | 01/03/2010 | Yes | No | |
| Results article | results | 01/04/2010 | Yes | No | |
| Results article | modellin late rectal toxicities results | 07/04/2011 | Yes | No | |
| Results article | results | 01/11/2011 | Yes | No | |
| Other publications | prospective analysis study | 01/01/2012 | Yes | No | |
| Results article | additional rectal toxicity endpoint results | 01/03/2012 | Yes | No | |
| Results article | results | 01/06/2012 | Yes | No | |
| Results article | long-term results | 01/04/2014 | Yes | No | |
| Other publications | secondary data analysis | 01/08/2017 | Yes | No | |
| Results article | two-years postradiotherapy biopsies results | 01/06/2018 | 15/03/2019 | Yes | No |