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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Bicalutamide

Criteria

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.