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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Conditions

Prostate Cancer

Interventions

Depo-Eligard®

Study Description

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:

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Medical Director

Affiliation: Astellas Pharma Europe B.V.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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