| Source of record | UK Trials |
| ISRCTN | ISRCTN47772397 |
| Date ISRCTN assigned | 06/04/2000 |
| Local reference number(s) | RT01 |
| Public title | High dose therapy in localised cancer of the prostate using conformal radiotherapy techniques |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer |
| Study hypothesis | To compare standard 64 Gy dose of conformal radiotherapy (CRT) with high dose 74 Gy CRT |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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 | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 05/01/1998 |
| Anticipated end date | 31/12/2001 |
| Status of trial | Completed |
| 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 |
| Publications | Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/15297138
2. http://www.ncbi.nlm.nih.gov/pubmed/15622611
3. http://www.ncbi.nlm.nih.gov/pubmed/16828908
4. http://www.ncbi.nlm.nih.gov/pubmed/16949694
5. http://www.ncbi.nlm.nih.gov/pubmed/17155990
6. http://www.ncbi.nlm.nih.gov/pubmed/17391791
7. http://www.ncbi.nlm.nih.gov/pubmed/17482880 |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Mr Matthew Sydes |
| Contact details | MRC Clinical Trials Unit
Cancer Division
222 Euston Road
London
United Kingdom
NW1 2DA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN47772397 |
| Date last extracted from ISRCTN register | 17/04/2008 |
