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ISRCTN
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ISRCTN16559899
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ClinicalTrials.gov identifier
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Public title
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A Multicentre Randomised and Comparative Trial to Assess the Tolerance, Efficacy and Pharmacokinetics of Escalating Doses of Casodex Versus Castration in the Treatment of Advanced Carcinoma of the Prostate
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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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ZEN7054IL/09
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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/cytologically confirmed metastatic or locally advanced (T3 or T4) prostate carcinoma. Confirmed within the last month
2. Life expectancy of more than 3 months
3. Prostate specific antigen (PSA) of at least five-times upper limit of normal reference range
4. Evaluable disease and fit to receive any of the treatment options
5. No previous or concurrent systemic therapy for prostate cancer
6. No radiotherapy to the prostate within the 3 months prior to entry into the trial
7. No previous medical history of another malignancy within the past 5 years
8. Adequate cardiac, renal and hepatic function
9. Eastern Cooperative Oncology Group (ECOG) performance 3 or 4
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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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01/01/1995
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Anticipated end date
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11/09/1996
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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: Castration, medical or surgical
2. Group B: Casodex (bicalutamide) taken orally. Cohorts of patients were recruited sequentially, into each arm of the randomised stages, to determine the maximum well tolerated dose. The first cohort of patients received 300 mg Casodex, then patients were randomised to 300 mg Casodex versus castration, then 450 mg Casodex versus castration, then 600 mg Casodex versus 450 mg Casodex versus castration. The trial was stopped at 600 mg Casodex.
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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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AstraZeneca Pharmaceuticals
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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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Sponsor
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AstraZeneca Clinical Research Group (UK)
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Address
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10 Logie Mill
Beaverbank Office Park
Lovie Green Road
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City/town
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Edinburgh
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Zip/Postcode
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EH7 4HG
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Country
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United Kingdom
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Sponsor website:
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http://www.astrazeneca.co.uk
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Date applied
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19/08/2002
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Last edited
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17/12/2007
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Date ISRCTN assigned
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19/08/2002
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