| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN16559899 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ZEN7054IL/09 |
| Public 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Prostate cancer |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1995 |
| Anticipated end date | 11/09/1996 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | AstraZeneca Pharmaceuticals |
| Sponsor name | AstraZeneca Clinical Research Group (UK) |
| Sponsor details | 10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
United Kingdom
EH7 4HG |
| Sponsor website | http://www.astrazeneca.co.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN16559899 |
| Date last extracted from ISRCTN register | 17/04/2008 |
