Trial Information
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
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
To evaluate change in PSA level following 4-9 months of bicalutamide therapy
Outcome Time Frame:
PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide)
Safety Issue:
No
Principal Investigator
Ana Marija Gjurovic
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Croatia: Agency for Medicinal Product and Medical Devices
Study ID:
NIS-OHR-CAS-2008/1
NCT ID:
NCT00871585
Start Date:
March 2009
Completion Date:
January 2010
Related Keywords:
- Advanced Prostate Cancer
- bicalutamide
- PSA
- advanced prostate cancer
- Prostatic Neoplasms