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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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400 advanced prostate cancer patients (outpatients or hospitalized) treated with bicalutamide in combination with medical or surgical castration according to standard clinical practice
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| Name | Affiliation | Role |
|---|---|---|
| Ana Marija Gjurovic | AstraZeneca | Study Director |
| Andreja Hasenohrl | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Čakovec | Croatia | ||||
| Research Site |
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| 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 |
| Dubrovnik |
| Croatia |
| Research Site | Karlovac | Croatia |
| Research Site | Pula | Croatia |
| Research Site | Rijeka | Croatia |
| Research Site | Sisak | Croatia |
| Research Site | Slavonski Brod | Croatia |
| Research Site | Split | Croatia |
| Research Site | Šibenik | Croatia |
| Research Site | Vinkovci | Croatia |
| Research Site | Virovitica | Croatia |
| Research Site | Vukovar | Croatia |
| Research Site | Zabok | Croatia |
| Research Site | Zadar | Croatia |
| Research Site | Zagreb | Croatia |