A randomised clinical trial of hormones plus radiotherapy vs hormone therapy alone in non-metastatic prostate cancer

ISRCTN	ISRCTN24991896
DOI	https://doi.org/10.1186/ISRCTN24991896
ClinicalTrials.gov (NCT)	NCT00002633
Protocol serial number	G9805643 (PR07)
Sponsor	Medical Research Council (MRC) Clinical Trials Unit - Cancer Division (UK)
Funder	Medical Research Council (UK)

Submission date: 06/04/2000
Registration date: 06/04/2000
Last edited: 18/10/2018

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

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-hormone-therapy-with-or-without-radiotherapy-in-advanced-prostate-cancer

Contact information

Prof MK Parmar
Scientific

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

Email	abc@email.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised clinical trial of hormones plus radiotherapy vs hormone therapy alone in non-metastatic prostate cancer
Study objectives	To evaluate any possible benefit from the addition of external beam radiation therapy to the treatment of patients with non-metastatic prostate cancer who have not had a radical prostatectomy and are receiving hormonal therapy. More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=58
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	All patients will receive hormonal manipulation. Patients are randomised to receive: 1. Additional radiotherapy (65-69Gy/35-37f) 2. No additional radiotherapy
Intervention type	Mixed
Primary outcome measure(s)	Overall survival
Key secondary outcome measure(s)	1. Time to disease progression 2. Symptomatic local control measured by the rates of surgical interventions necessary for symptomatic local disease (I.e. the combined incidences of TURPs, stent insertions, nephrostomies and colostomies) 3. Quality of Life measured by the FACT-P questionnaire
Completion date	31/08/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	1200
Key inclusion criteria	1. Histological diagnosis of adenocarcinoma of the prostate within 6 months of randomisation 2. Either (a) clinical stage T3 or T4, NO or NX, MO or (b) clinical stage T2, NO or NX, MO with Prostate-Specific Antigen (PSA) greater than 40 or (c) clinical stage T2, NO or NX, MO with PSA greater than 20 and Gleason sum score greater than or equal to 8 3. The patient must have a bone scan (with X-rays of any areas of abnormal uptake) reported as being free of evidence of bony metastases within 16 weeks prior to randomisation (if not already on hormones) or 16 weeks prior to the start of hormones (if on hormones already) 4. No previous treatment for prostate cancer apart from transurethral resection. However, the patient may have received prior hormone therapy during the 12 weeks prior to randomisation, provided that (a) a negative bone scan was demonstrated, preferably within the 16 weeks prior to starting hormone therapy but certainly within 2 weeks after starting hormone therapy and (b) baseline PSA within 4 weeks prior to hormone therapy is available 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 6. Patients must be less than 80 years old 7. Written informed consent
Key exclusion criteria	1. A history of previous or concurrent malignancy other than non-melanomatous skin cancer within 5 years of diagnosis of the prostatic cancer. 2. The presence of small-cell or transitional-cell carcinoma in the biopsy specimen. 3. Any contraindication to pelvic radiotherapy (e.g. inflammatory bowel disease). 4. Any serious non-malignant disease resulting in a life expectancy of less than 5 years.
Date of first enrolment	01/06/1999
Date of final enrolment	31/08/2005

Locations

Countries of recruitment

United Kingdom
England
United States of America

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/12/2011		Yes	No
Results article	results	01/07/2015		Yes	No
Protocol article	protocol	01/11/2000		Yes	No
Other publications	appraisal	01/06/2005		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

Editorial Notes

18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)