Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PR06
Study information
Scientific title
A randomised trial of total prostatectomy versus radiotherapy versus no immediate treatment in early prostate cancer
Acronym
Study hypothesis
To determine whether total prostatectomy or radiotherapy confer benefit in terms of survival or development of metastases over no immediate treatment alone.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
1. Survival time to metastases
2. Morbidity
3. Local recurrence
4. Quality of life
5. Time to progression
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/1994
Overall trial end 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.
Eligibility
Participant 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)
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
1800 planned, 35 recruited at time of early closure in 1996.
Participant exclusion criteria
Opposite of inclusion criteria
Recruitment start date
01/06/1994
Recruitment end date
01/06/1996
Locations
Countries of recruitment
Belgium, Switzerland, United Kingdom
Trial participating centre
Department of Urology
London
SW3 6JJ
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Early closure in 1996 reported in 2004 in http://www.ncbi.nlm.nih.gov/pubmed/15610132
Publication citations
-
Results
Early closure of a randomized controlled trial of three treatment approaches to early localised prostate cancer: the MRC PR06 trial., BJU Int., 2004, 94, 9, 1400-1401, doi: 10.1111/j.1464-410X.2004.05224_3.x.