Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CASODEX 0307
Study information
Scientific 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
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Prostate
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
Casodex
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1990
Overall trial end date
30/06/1993
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1990
Recruitment end date
30/06/1993
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
AstraZeneca Clinical Research Group (UK)
Sponsor details
10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
AstraZeneca Pharmaceuticals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1998 results in https://www.ncbi.nlm.nih.gov/pubmed/9510340 (added 21/01/2019)