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 |
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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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Casodex |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/1995 |
Completion date | 11/09/1996 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Male |
Target number of participants | Not provided at time of registration |
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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
AstraZeneca Clinical Research Group (UK)
Industry
Industry
10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom
Website | http://www.astrazeneca.co.uk |
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https://ror.org/04r9x1a08 |
Funders
Funder type
Industry
AstraZeneca Pharmaceuticals
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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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.