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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00871585
Other study ID # NIS-OHR-CAS-2008/1
Secondary ID
Status Completed
Phase N/A
First received March 27, 2009
Last updated April 14, 2010
Start date March 2009
Est. completion date January 2010

Study information

Verified date April 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Croatia: Agency for Medicinal Product and Medical Devices
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 340
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Male
Age group 40 Years and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Croatia Research Site Cakovec
Croatia Research Site Dubrovnik
Croatia Research Site Karlovac
Croatia Research Site Pula
Croatia Research Site Rijeka
Croatia Research Site Sibenik
Croatia Research Site Sisak
Croatia Research Site Slavonski brod
Croatia Research Site Split
Croatia Research Site Vinkovci
Croatia Research Site Virovitica
Croatia Research Site Vukovar
Croatia Research Site Zabok
Croatia Research Site Zadar
Croatia Research Site Zagreb

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary bicalutamide prescribing practice based on prostate cancer stage 1 measure (at the time of bicalutamde th introduction) No
Secondary to evaluate PSA level after 4-12 weeks of bicalutamide therapy PSA - 1 measures (1-3 m following bicalutamide) No
Secondary 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) No
Secondary to evaluate percentage of patients with disease progression 2 measures at 1st and 2nd visit No
Secondary to evaluate withdrawals due to adverse events 2 measures, at 1st and 2nd visit No
Secondary to evaluate withdrawals due to Croatian Institute for Health Insurance guidelines for bicalutamide prescription 2 measures, at 1st and 2nd visit No
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