Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZEN7054IL/09
Study information
Scientific title
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
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 cancer
Intervention
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.
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
01/01/1995
Overall trial end date
11/09/1996
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
Not provided at time of registration
Total final enrolment
248
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1995
Recruitment end date
11/09/1996
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
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
2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/16771791 (added 29/10/2019)