An observational study in Advanced Prostate Cancer, sponsored by AstraZeneca. Completed at 15 sites in Croatia. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2010-04-15.
Sponsored by AstraZeneca · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 340 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
400 advanced prostate cancer patients (outpatients or hospitalized) treated with bicalutamide in combination with medical or surgical castration according to standard clinical practice
Exclusion Criteria:
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)
bicalutamide prescribing practice based on prostate cancer stage
Time frame: 1 measure (at the time of bicalutamde th introduction)
to evaluate PSA level after 4-12 weeks of bicalutamide therapy
Time frame: PSA - 1 measures (1-3 m following bicalutamide)
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)
to evaluate percentage of patients with disease progression
Time frame: 2 measures at 1st and 2nd visit
to evaluate withdrawals due to adverse events
Time frame: 2 measures, at 1st and 2nd visit
to evaluate withdrawals due to Croatian Institute for Health Insurance guidelines for bicalutamide prescription
Time frame: 2 measures, at 1st and 2nd visit
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AstraZeneca