Non-interventional Observational Study to Evaluate Change of PSA Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide in Combination With Medical or Surgical Castration

AstraZeneca1 site in 1 country340 target enrollmentMarch 2009

ConditionsAdvanced Prostate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Advanced Prostate Cancer
Sponsor: AstraZeneca
Enrollment: 340
Locations: 1
Primary Endpoint: To evaluate change in PSA level following 4-9 months of bicalutamide therapy
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

January 2010

Last Updated

16 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

Outcomes

Primary Outcomes

To evaluate change in PSA level following 4-9 months of bicalutamide therapy

Time Frame: PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide)

Secondary Outcomes

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)