Evaluation of Prostate-Specific Antigen (PSA) Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00871585

Enrollment

340

Registered

2009-03-30

Start date

2009-03-31

Completion date

2010-01-31

Last updated

2010-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Prostate Cancer

Keywords

bicalutamide, PSA, advanced prostate cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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)

Secondary

Measure	Time frame
to evaluate PSA level after 4-12 weeks of bicalutamide therapy	PSA - 1 measures (1-3 m following bicalutamide)
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)
bicalutamide prescribing practice based on prostate cancer stage	1 measure (at the time of bicalutamde th introduction)
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
to evaluate percentage of patients with disease progression	2 measures at 1st and 2nd visit

Countries

Croatia

Outcome results