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

ISRCTN	ISRCTN16559899
DOI	https://doi.org/10.1186/ISRCTN16559899
Protocol serial number	ZEN7054IL/09
Sponsor	AstraZeneca Clinical Research Group (UK)
Funder	AstraZeneca Pharmaceuticals

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Casodex
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	11/09/1996

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Total final enrolment	248
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1995
Date of final enrolment	11/09/1996

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2006	29/10/2019	Yes	No

29/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.