Evaluation of Prostate-Specific Antigen (PSA) Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide

Completed

• Conditions: Advanced Prostate Cancer

• Registration Number: NCT00871585
• Lead Sponsor: AstraZeneca

Brief Summary

Prospective, non-comparative, non-interventional, observational study to collect and analyse real life environment data on advanced prostate cancer patients receiving combination treatment of medical or surgical castration and bicalutamide according to routine medical practice in Croatia. The main aim is to evaluate change of PSA level and prescribing practices based on prostate cancer stage.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-27
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-14
• Last Update Posted: 2010-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 340

Inclusion Criteria

• Patients with diagnosis of advanced prostate cancer
• Patients who are already treated with bicalutamide for at least 4 weeks and maximum 12 weeks
• Patients capable of signing ICF

Exclusion Criteria

• Patients with hypersensitivity to bicalutamide
• Patients on therapy with terfenadin, astemizol or cisapride
• Participation in a clinical study during the last 30 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate change in PSA level following 4-9 months of bicalutamide therapy	PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide)

Secondary Outcome Measures

Name	Time	Method
bicalutamide prescribing practice based on prostate cancer stage	1 measure (at the time of bicalutamde th introduction)
to evaluate PSA level after 4-12 weeks of bicalutamide therapy	PSA - 1 measures (1-3 m following bicalutamide)
to asses time to disease progression based on PSA values	PSA - 3 measures (at the time of bicalutamdie introduction, 1-3 m and 4-9 m following bicalutamide)
to evaluate percentage of patients with disease progression	2 measures at 1st and 2nd visit
to evaluate withdrawals due to adverse events	2 measures, at 1st and 2nd visit
to evaluate withdrawals due to Croatian Institute for Health Insurance guidelines for bicalutamide prescription	2 measures, at 1st and 2nd visit

Trial Locations

Locations (1)

Research Site; 🇭🇷 Zagreb, Croatia