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

NCT ID: NCT00871585

Last Updated: 2010-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Ana Marija Gjurovic

Role: STUDY_DIRECTOR

AstraZeneca

Andreja Hasenohrl

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

Čakovec, , Croatia

Site Status

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Dubrovnik, , Croatia

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Karlovac, , Croatia

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Pula, , Croatia

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Rijeka, , Croatia

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Sisak, , Croatia

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Slavonski Brod, , Croatia

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Split, , Croatia

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Šibenik, , Croatia

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Vinkovci, , Croatia

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Virovitica, , Croatia

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Vukovar, , Croatia

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Zabok, , Croatia

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Zadar, , Croatia

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Zagreb, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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NIS-OHR-CAS-2008/1

Identifier Type: -

Identifier Source: org_study_id

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