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ISRCTN
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ISRCTN92984394
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ClinicalTrials.gov identifier
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Public title
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A Pilot Study to Assess Flutamide Monotherapy Compared With Maximal Androgen Blockade in Metastatic 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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SCTO46
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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 cancer
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Participants - inclusion criteria
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1. Histologically confirmed prostate carcinoma 2. Skeletal metastases on bone scan, with radiological conformation if appropriate, or typical sclerotic metastases on X-ray
3. Life expectancy >6 months
4. Suitable for treatment by any of the study therapies
5. No previous hormonal therapy
6. Not currently receiving corticosteroids, spironolactone or aminoglutethamide
7. Adequate renal and hepatic function
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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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01/01/1994
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Anticipated end date
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30/09/1996
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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. Group A: Oral flutamide 250 mg three times daily
2. Group B: Oral flutamide 250 mg three times daily plus either orchidectomy or the lutenizing hormone releasing hormone (LHRH) analogue Zoladex (goserelin acetate). Zoladex is given by monthly injection at the dosage recommended by the manufacturer
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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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Schering-Plough Ltd (UK)
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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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Schering-Plough Ltd (UK)
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Address
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Schering-Plough House
Shire Park
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City/town
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Welwyn Garden City
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Zip/Postcode
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AL7 1TW
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Country
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United Kingdom
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Date applied
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19/08/2002
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Last edited
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29/05/2008
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Date ISRCTN assigned
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19/08/2002
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