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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871585
• Other study ID #: NIS-OHR-CAS-2008/1
• Status: Completed
• Phase: N/A
• First received: March 27, 2009
• Last updated: April 14, 2010
• Start date: March 2009
• Est. completion date: January 2010

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Prostatic Neoplasms

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Croatia, 

Outcome

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