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

Not Applicable

Completed

• Conditions: Prostate cancer; Cancer; Prostate

• Registration Number: ISRCTN16559899
• Lead Sponsor: AstraZeneca Clinical Research Group (UK)

Brief Summary

2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/16771791 (added 29/10/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 1996-09-11
• Study Start: 2002-08-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 248

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

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ot provided at time of registration

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration