Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
15/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZEN7054IL/09

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Casodex

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1995

Overall trial end date

11/09/1996

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1995

Recruitment end date

11/09/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

AstraZeneca Clinical Research Group (UK)

Sponsor details

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

Sponsor type

Industry

Website

http://www.astrazeneca.co.uk

Funders

Funder type

Industry

Funder name

AstraZeneca Pharmaceuticals

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes