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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00871585
First received: March 27, 2009
Last updated: April 14, 2010
Last verified: April 2010
History of Changes
  Purpose

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
Advanced Prostate Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bicalutamide prescribing practice based on prostate cancer stage [ Time Frame: 1 measure (at the time of bicalutamde th introduction) ] [ Designated as safety issue: No ]
  • to evaluate PSA level after 4-12 weeks of bicalutamide therapy [ Time Frame: PSA - 1 measures (1-3 m following bicalutamide) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • to evaluate percentage of patients with disease progression [ Time Frame: 2 measures at 1st and 2nd visit ] [ Designated as safety issue: No ]
  • to evaluate withdrawals due to adverse events [ Time Frame: 2 measures, at 1st and 2nd visit ] [ Designated as safety issue: No ]
  • to evaluate withdrawals due to Croatian Institute for Health Insurance guidelines for bicalutamide prescription [ Time Frame: 2 measures, at 1st and 2nd visit ] [ Designated as safety issue: No ]

Enrollment: 340
Study Start Date: March 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871585

Locations
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, Croatia
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Ana Marija Gjurovic AstraZeneca
Study Chair: Andreja Hasenohrl AstraZeneca
  More Information

No publications provided

Responsible Party: Ana Marija Gjurovic, Medical&Regulatory Manager, AstraZeneca
ClinicalTrials.gov Identifier: NCT00871585     History of Changes
Other Study ID Numbers: NIS-OHR-CAS-2008/1
Study First Received: March 27, 2009
Last Updated: April 14, 2010
Health Authority: Croatia: Agency for Medicinal Product and Medical Devices

Keywords provided by AstraZeneca:
bicalutamide
PSA
advanced prostate cancer

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

ClinicalTrials.gov processed this record on June 13, 2013