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ISRCTN
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ISRCTN81687381
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DOI
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10.1186/ISRCTN81687381
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised trial of total prostatectomy versus radiotherapy versus no immediate treatment in early prostate cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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PR06
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Study hypothesis
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To determine whether total prostatectomy or radiotherapy confer benefit in terms of survival or development of metastases over no immediate treatment alone.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Belgium, Switzerland, United Kingdom
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Disease/condition/study domain
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Prostate cancer
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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Opposite of inclusion criteria
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Anticipated start date
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01/06/1994
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Anticipated end date
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01/06/1996
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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1800 planned, 35 recruited at time of early closure in 1996.
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Interventions
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1. The first group receives total prostatectomy
2. The second receive radiotherapy
3. The third receive no immediate treatment
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Primary outcome measure(s)
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1. Survival time to metastases
2. Morbidity
3. Local recurrence
4. Quality of life
5. Time to progression
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Early closure in 1996 reported in 2004 in http://www.ncbi.nlm.nih.gov/pubmed/15610132
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Contact name
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Mr
Robert
Shearer
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Address
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Department of Urology
The Royal Marsden
Fullham Road
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City/town
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London
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Zip/Postcode
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SW3 6JJ
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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06/04/2000
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Last edited
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29/07/2009
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Date ISRCTN assigned
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06/04/2000
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