High dose therapy in localised cancer of the prostate using conformal radiotherapy techniques

ISRCTN	ISRCTN47772397
DOI	https://doi.org/10.1186/ISRCTN47772397
Protocol serial number	RT01
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

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 of protocol

Not provided at time of registration

Contact information

Mr Matthew Sydes
Scientific

MRC Clinical Trials Unit
Cancer Division
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	High dose therapy in localised cancer of the prostate using conformal radiotherapy techniques
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	Local tumour control, incidence of biochemical failure, metastases, survival, side effects of radiation, quality of life and health economic resources
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2001

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Male
Target sample size at registration	843
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	05/01/1998
Date of final enrolment	31/12/2001

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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?
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
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
Results article	two-years postradiotherapy biopsies results	01/06/2018	15/03/2019	Yes	No
Protocol article	protocol	01/08/2004		Yes	No
Protocol article	protocol	01/07/2006		Yes	No
Other publications	questionnaire	01/11/2004		Yes	No
Other publications	prospective analysis study	01/01/2012		Yes	No
Other publications	secondary data analysis	01/08/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

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.