Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00919477
• Lead Sponsor: AstraZeneca

Brief Summary

To gather information on the safety of monotherapy of Casodex® tablets 80 mg, targeting prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-11
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-21
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 712

Inclusion Criteria

• Prostate cancer patients who have no history of receiving endocrine therapy (including surgical castration), and who plan to undergo Casodex® tablets monotherapy for not less than 12 months

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse event incidence	Time since starting Casodex monotherapy, monthly

Secondary Outcome Measures

Name	Time	Method
improvement of prostate cancer using Tumor marker PSA	Time since starting Casodex monotherapy, monthly
Maintenance of sexual function	At 3 months since starting Casodex monotherapy,

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamagata, Japan