High dose therapy in localised cancer of the prostate using conformal radiotherapy techniques
| ISRCTN | ISRCTN47772397 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47772397 |
| Secondary identifying numbers | RT01 |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 25/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Mr Matthew Sydes
Scientific
Scientific
MRC Clinical Trials Unit
Cancer Division
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | High dose therapy in localised cancer of the prostate using conformal radiotherapy techniques |
| 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Male |
| Target number of participants | 843 |
| 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 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
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | 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 |
Editorial Notes
25/10/2022: Internal review.
15/03/2019: Publication reference added.
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
30/03/2017: Publication reference added.
