|
ISRCTN
|
ISRCTN44967321
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A Study to Compare the Effect of Two Blinded Doses of Casodex (ICI 176,334 100 mg and 150 mg daily) and Castration in the Treatment of Advanced Carcinoma of the Prostate
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
CASODEX 0307
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Prostate
|
|
Participants - inclusion criteria
|
1. Locally advanced stage T3 or T4 carcinoma of the prostate with prostate-specific antigen times five the upper limit of normal or metastatic disease
2. Gleason grade 2-10
3. Evaluable disease
4. Fit to receive treatment
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/01/1990
|
|
Anticipated end date
|
30/06/1993
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
STAGE I PATIENTS: Patients are randomised to either:
1. Casodex 100 mg
2. Casodex 150 mg
3. Castration
STAGE II PATIENTS: Patients are randomised to either:
1. Casodex 150 mg
2. Castration
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
AstraZeneca Pharmaceuticals (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
AstraZeneca Clinical Research Group (UK)
|
|
Address
|
10 Logie Mill
Beaverbank Office Park
Lovie Green Road
|
|
City/town
|
Edinburgh
|
|
Zip/Postcode
|
EH7 4HG
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.astrazeneca.co.uk
|
|
Date applied
|
19/08/2002
|
|
Last edited
|
22/05/2008
|
|
Date ISRCTN assigned
|
19/08/2002
|