A randomised trial of total prostatectomy versus radiotherapy versus no immediate treatment in early prostate cancer

ISRCTN	ISRCTN81687381
DOI	https://doi.org/10.1186/ISRCTN81687381
Protocol serial number	PR06
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Robert Shearer
Scientific

Department of Urology
The Royal Marsden
Fullham Road
London
SW3 6JJ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised trial of total prostatectomy versus radiotherapy versus no immediate treatment in early prostate cancer
Study objectives	To determine whether total prostatectomy or radiotherapy confer benefit in terms of survival or development of metastases over no immediate treatment alone.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	1. The first group receives total prostatectomy 2. The second receive radiotherapy 3. The third receive no immediate treatment
Intervention type	Other
Primary outcome measure(s)	1. Survival time to metastases 2. Morbidity 3. Local recurrence 4. Quality of life 5. Time to progression
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/06/1996
Reason abandoned (if study stopped)	The overall target for recruitment was 1800 patients, but the trial accrued only 35 (mean age 69 years, median PSA level at entry 12 ng/mL). Recruitment was formally halted following the recommendation of the independent Data Monitoring Committee in October 1996.

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target sample size at registration	1800
Key inclusion criteria	1. Newly diagnosed, biopsy-proven adenocarcinoma of the prostate 2. Stage T1b/T1c/T2, N0, M0 3. Negative bone scan 4. No previous malignancy (except skin)
Key exclusion criteria	Opposite of inclusion criteria
Date of first enrolment	01/06/1994
Date of final enrolment	01/06/1996

Department of Urology

London
SW3 6JJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	Early closure in reported in 2004	01/12/2004		Yes	No

19/09/2017: internal review.