Clinical trial NCT00871585: Evaluation of Prostate-Specific Antigen (PSA) Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Prostate Cancer
Keywords: bicalutamide
PSA
advanced prostate cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 340
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 400 advanced prostate cancer patients (outpatients or hospitalized) treated with bicalutamide in combination with medical or surgical castration according to standard clinical practice

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.


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

Primary outcomes:
measure: To evaluate change in PSA level following 4-9 months of bicalutamide therapy
timeFrame: PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide)
Secondary outcomes:
measure: bicalutamide prescribing practice based on prostate cancer stage
timeFrame: 1 measure (at the time of bicalutamde th introduction)
measure: to evaluate PSA level after 4-12 weeks of bicalutamide therapy
timeFrame: PSA - 1 measures (1-3 m following bicalutamide)
measure: to asses time to disease progression based on PSA values
timeFrame: PSA - 3 measures (at the time of bicalutamdie introduction, 1-3 m and 4-9 m following bicalutamide)
measure: to evaluate percentage of patients with disease progression
timeFrame: 2 measures at 1st and 2nd visit
measure: to evaluate withdrawals due to adverse events
timeFrame: 2 measures, at 1st and 2nd visit
measure: to evaluate withdrawals due to Croatian Institute for Health Insurance guidelines for bicalutamide prescription
timeFrame: 2 measures, at 1st and 2nd visit
Other outcomes:
Locations:
city: Cakovec
country: Croatia
facility: Research Site
city: Dubrovnik
country: Croatia
facility: Research Site
city: Karlovac
country: Croatia
facility: Research Site
city: Pula
country: Croatia
facility: Research Site
city: Rijeka
country: Croatia
facility: Research Site
city: Sibenik
country: Croatia
facility: Research Site
city: Sisak
country: Croatia
facility: Research Site
city: Slavonski brod
country: Croatia
facility: Research Site
city: Split
country: Croatia
facility: Research Site
city: Vinkovci
country: Croatia
facility: Research Site
city: Virovitica
country: Croatia
facility: Research Site
city: Vukovar
country: Croatia
facility: Research Site
city: Zabok
country: Croatia
facility: Research Site
city: Zadar
country: Croatia
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Ana Marija Gjurovic
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Andreja Hasenohrl
role: STUDY_CHAIR
References: