Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients
NCT ID: NCT01793077
Last Updated: 2014-01-13
Study Results
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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COMPLETED
259 participants
OBSERVATIONAL
2011-12-31
2013-12-31
Brief Summary
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Once the examining physician has decided on the therapeutic approach and if the selection criteria are fulfilled, he will propose the patient to participate in the study. An informed consent form will be collected for all participants in the study.
There are 2 possible study visits that coincide with a routine consultation, namely visit 1 (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment benefit of the patient.
Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both visits, if available.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Prostate Cancer patients
Depo-Eligard®
Subcutaneous
Interventions
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Depo-Eligard®
Subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
MALE
No
Sponsors
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Veeda Clinical Research
INDUSTRY
Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Site: 5
Antwerp, Antwerp, Belgium
Site: 8
Antwerp, Antwerp, Belgium
Site: 9
Antwerp, Antwerp, Belgium
Site: 14
Antwerp, Antwerp, Belgium
Site: 4
Antwerp, Antwerp, Belgium
Site: 33
Merksem, Antwerp, Belgium
Site: 1
Turnhout, Antwerp, Belgium
Site: 23
Brussels, Brussels Capital, Belgium
Site: 13
Brussels, Brussels Capital, Belgium
Site: 24
Uccle, Brussels Capital, Belgium
Site: 32
Aalst, East Flanders, Belgium
Site: 34
Dendermonde, East Flanders, Belgium
Site: 11
Ghent, East Flanders, Belgium
Site: 17
Oudenaarde, East Flanders, Belgium
Site: 18
Tienen, Flemish Brabant, Belgium
Site: 39
La Louvière, Hainaut, Belgium
Site: 37
Sint-Truiden, Limburg, Belgium
Site: 38
Liège, Liège, Belgium
Site: 26
Lasne-Chapelle-Saint-Lambert, Walloon Brabant, Belgium
Site: 21
Ieper, West Flanders, Belgium
Site: 20
Izegem, West Flanders, Belgium
Site: 25
Kortijk, West Flanders, Belgium
Site: 31
Ostend, West Flanders, Belgium
Countries
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Other Identifiers
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BE-11-EGD-04
Identifier Type: -
Identifier Source: org_study_id
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