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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Bicalutamide

• Registration Number: NCT00846976
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1994-12
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
200 mg Casodex	Bicalutamide	-

Primary Outcome Measures

Name	Time	Method
Safety profile of patients treated with a 200 mg daily dose of CASODEX	every three months

Trial Locations

Locations (1)

Research Site; 🇺🇸 New York, New York, United States