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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16559899
Enrollment
Unknown
Registered
2002-08-19
Start date
1995-01-01
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer Prostate

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

Sponsors

AstraZeneca Clinical Research Group (UK)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026