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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


N/A
40 Years
N/A
Not Enrolling
Male
Advanced Prostate Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To evaluate change in PSA level following 4-9 months of bicalutamide therapy

Outcome Time Frame:

PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide)

Safety Issue:

No

Principal Investigator

Ana Marija Gjurovic

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Croatia: Agency for Medicinal Product and Medical Devices

Study ID:

NIS-OHR-CAS-2008/1

NCT ID:

NCT00871585

Start Date:

March 2009

Completion Date:

January 2010

Related Keywords:

  • Advanced Prostate Cancer
  • bicalutamide
  • PSA
  • advanced prostate cancer
  • Prostatic Neoplasms

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