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ISRCTN
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ISRCTN14557194
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ClinicalTrials.gov identifier
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Public title
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A Prospective Study to Compare Immediate with Deferred Treatment in Advanced, Localised and Asymptomatic Metastatic Newly Diagnosed Prostatic Carcinoma
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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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PR03
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Study hypothesis
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Not provided at time of registration.
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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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United Kingdom
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Disease/condition/study domain
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Prostate
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Participants - inclusion criteria
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1. Histologically proven adenocarcinoma of the prostate
2. Stage T2-T4 M0 or T1-T4 M1 (provided metastases are asymptomatic)
3. World Health Organisation (WHO) performance status 0-2
4. Life expectancy of >1 year
5. No previous or coexisting non prostatic malignancy except basal cell carcinoma
6. No previous treatment for prostatic carcinoma other than transurethral resection (TUR)
7. Patients in whom a deferred policy is inappropriate should not be entered into this study
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/08/2000
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Anticipated end date
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01/08/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration.
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Interventions
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1. Immediate Group: Total or subcapsular orchidectomy or administration of a Lutenizing Hormone Releasing Hormone (LHRH) analogue. Suggested LHRH analogues are goserelin acetate (Zoladex) 3.6 mg monthly or leuprorelin (Prostap SR) 3.75 mg monthly. LHRH treatment to start within 6 weeks of randomisation.
2. Deferred Group: No hormone treatment until disease progression. The original protocol specified orchidectomy only as the method of androgen deprivation. The protocol was later modified to allow the use of LHRH analogues.
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Primary outcome measure(s)
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Not provided at time of registration.
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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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UK Medical Research Council
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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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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19/08/2002
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Last edited
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10/09/2007
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Date ISRCTN assigned
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19/08/2002
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