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
Secondary identifying numbers ZEN7054IL/09
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
29/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleA 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 objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedProstate cancer
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Casodex
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1995
Completion date11/09/1996

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexMale
Target number of participantsNot provided at time of registration
Total final enrolment248
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/1995
Date of final enrolment11/09/1996

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

AstraZeneca Clinical Research Group (UK)
Industry

10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom

Website http://www.astrazeneca.co.uk
ROR logo "ROR" https://ror.org/04r9x1a08

Funders

Funder type

Industry

AstraZeneca Pharmaceuticals

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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