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

NCT00871585 | Completed

• 1 other identifier: NIS-OHR-CAS-2008/1
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 15

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.

Conditions

Advanced Prostate Cancer

Keywords

bicalutamide; PSA; advanced prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• bicalutamide prescribing practice based on prostate cancer stage

  1 measure (at the time of bicalutamde th introduction)

• 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)

• to evaluate percentage of patients with disease progression

  2 measures at 1st and 2nd visit

• to evaluate withdrawals due to adverse events

  2 measures, at 1st and 2nd visit

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients with hypersensitivity to bicalutamide
• Patients on therapy with terfenadin, astemizol or cisapride
• Participation in a clinical study during the last 30 days

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (15)

Research Site

Čakovec, Croatia

Location

Research Site

Dubrovnik, Croatia

Location

Research Site

Karlovac, Croatia

Location

Research Site

Pula, Croatia

Location

Research Site

Rijeka, Croatia

Location

Research Site

Sisak, Croatia

Location

Research Site

Slavonski Brod, Croatia

Location

Research Site

Split, Croatia

Location

Research Site

Šibenik, Croatia

Location

Research Site

Vinkovci, Croatia

Location

Research Site

Virovitica, Croatia

Location

Research Site

Vukovar, Croatia

Location

Research Site

Zabok, Croatia

Location

Research Site

Zadar, Croatia

Location

Research Site

Zagreb, Croatia

Location

Study Officials

• Ana Marija Gjurovic

  AstraZeneca

  STUDY DIRECTOR

• Andreja Hasenohrl

  AstraZeneca

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 15, 2010

Record last verified: 2010-04

Locations

CR (15)