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Brief Title: 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
Official Title: Phase IV, Non-interventional, Prospective, Open Label, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients
Study ID: NCT01793077
Brief Summary: Tremodi is an observational, non-interventional, prospective, open-label, non-comparative study that will collect real life data of a treatment with Depo-Eligard® in 3 different administrations in male prostate cancer patients. 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.
Detailed Description:
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Site: 5, Antwerpen, Antwerp, Belgium
Site: 8, Antwerpen, Antwerp, Belgium
Site: 9, Antwerpen, Antwerp, Belgium
Site: 14, Antwerpen, Antwerp, Belgium
Site: 4, Antwerpen, Antwerp, Belgium
Site: 33, Merksem, Antwerp, Belgium
Site: 1, Turnhout, Antwerp, Belgium
Site: 13, Brussel, Brussels Capital Region, Belgium
Site: 23, Bruxelles, Brussels Capital Region, Belgium
Site: 24, Uccle, Brussels Capital Region, Belgium
Site: 32, Aalst, East Flanders, Belgium
Site: 34, Dendermonde, East Flanders, Belgium
Site: 11, Gent, 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: 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, Oostende, West Flanders, Belgium
Site: 38, Liège, , Belgium
Name: Medical Director
Affiliation: Astellas Pharma Europe B.V.
Role: STUDY_DIRECTOR