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
| ISRCTN | ISRCTN44967321 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44967321 |
| Secondary identifying numbers | CASODEX 0307 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 21/01/2019
- 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 |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 |
| 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 |
| 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 |
| 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 | 01/01/1990 |
| Completion date | 30/06/1993 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1990 |
| Date of final enrolment | 30/06/1993 |
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 |
|---|---|
"ROR" |
https://ror.org/04r9x1a08 |
Funders
Funder type
Industry
AstraZeneca Pharmaceuticals (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | results | 01/03/1998 | 21/01/2019 | Yes | No |
Editorial Notes
21/01/2019: Publication reference added.
