Advanced Prostate Cancer Clinical Trial
Official title:
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
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 |
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.
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 |
Observational Model: Case-Only, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Croatia,
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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