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Completed

NCT Number: NCT00871585

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

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.

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Key information

Conditions

Advanced Prostate Cancer

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Research Site, Dubrovnik, Croatia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2009
Registry last updated
Apr 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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