Treatment Protocol to Monitor the Safety of a 200 mg Dose of Bicalutamide in Patients With Advanced Prostate Cancer

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Bicalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00846976

D6874C00014

Details and patient eligibility

About

This is an open label, single-centered treatment protocol designed to monitor the safety of patients treated with a 200 mg daily dose of CASODEX. Patient will receive CASODEX as long as physician feels that he is benefiting from this form of therapy.

Enrollment: 101 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed adenocarcinoma of the prostate gland
• Patients with advanced prostate cancer
• Adult male over the age of 18 years old
• Normal liver function (AST < 2 x Upper Limit Normal)

Exclusion criteria

• ECOG performance status of 4.
• Previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last 5 years.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

200 mg Casodex

Experimental group

Treatment:

Drug: Bicalutamide