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

April 14, 2010 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Advanced Prostate Cancer

Study Type

Observational

Enrollment (Actual)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Croatia
- - 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, Croatia
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate change in PSA level following 4-9 months of bicalutamide therapy Time Frame: PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide)	PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide)

Secondary Outcome Measures

Outcome Measure	Time Frame
bicalutamide prescribing practice based on prostate cancer stage Time Frame: 1 measure (at the time of bicalutamde th introduction)	1 measure (at the time of bicalutamde th introduction)
to evaluate PSA level after 4-12 weeks of bicalutamide therapy Time Frame: PSA - 1 measures (1-3 m following bicalutamide)	PSA - 1 measures (1-3 m following bicalutamide)
to asses time to disease progression based on PSA values Time Frame: PSA - 3 measures (at the time of bicalutamdie introduction, 1-3 m and 4-9 m following bicalutamide)	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 Time Frame: 2 measures at 1st and 2nd visit	2 measures at 1st and 2nd visit
to evaluate withdrawals due to adverse events Time Frame: 2 measures, at 1st and 2nd visit	2 measures, at 1st and 2nd visit
to evaluate withdrawals due to Croatian Institute for Health Insurance guidelines for bicalutamide prescription Time Frame: 2 measures, at 1st and 2nd visit	2 measures, at 1st and 2nd visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: Ana Marija Gjurovic, AstraZeneca
Study Chair: Andreja Hasenohrl, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria