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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00871585
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : April 15, 2010
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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.

Condition or disease
Advanced Prostate Cancer

Study Type : Observational
Actual Enrollment : 340 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : March 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. bicalutamide prescribing practice based on prostate cancer stage [ Time Frame: 1 measure (at the time of bicalutamde th introduction) ]
  2. to evaluate PSA level after 4-12 weeks of bicalutamide therapy [ Time Frame: PSA - 1 measures (1-3 m following bicalutamide) ]
  3. 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) ]
  4. to evaluate percentage of patients with disease progression [ Time Frame: 2 measures at 1st and 2nd visit ]
  5. to evaluate withdrawals due to adverse events [ Time Frame: 2 measures, at 1st and 2nd visit ]
  6. to evaluate withdrawals due to Croatian Institute for Health Insurance guidelines for bicalutamide prescription [ Time Frame: 2 measures, at 1st and 2nd visit ]

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00871585

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, Croatia
Sponsors and Collaborators
Study Director: Ana Marija Gjurovic AstraZeneca
Study Chair: Andreja Hasenohrl AstraZeneca

Responsible Party: Ana Marija Gjurovic, Medical&Regulatory Manager, AstraZeneca Identifier: NCT00871585     History of Changes
Other Study ID Numbers: NIS-OHR-CAS-2008/1
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: April 15, 2010
Last Verified: April 2010

Keywords provided by AstraZeneca:
advanced prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents