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 |
| Protocol serial number | CASODEX 0307 |
| Sponsor | AstraZeneca Clinical Research Group (UK) |
| Funder | AstraZeneca Pharmaceuticals (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| 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 | 30/06/1993 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| 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
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
