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
- Conditions
- Prostate Cancer
- Interventions
- Drug: Depo-Eligard®
- Registration Number
- NCT01793077
- Lead Sponsor
- Astellas Pharma Europe B.V.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 259
- Patients having been prescribed Depo-Eligard® 7.5 mg - 22.5 mg - 45 mg in accordance with the terms of the marketing authorization.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prostate Cancer patients Depo-Eligard® -
- Primary Outcome Measures
Name Time Method Evaluation of tolerability of treatment on a 4 point scale Last Visit (after at least 180 days of treatment)
- Secondary Outcome Measures
Name Time Method Investigator satisfaction with treatment Last Visit (after at least 180 days of treatment) Overall patient's assessment of treatment benefit Last Visit (after at least 180 days of treatment) Frequency of use of dosing schedules of Depo-Eligard® and the reasons for selecting a schedule Day 1 and Last Visit (after at least 180 days of treatment) Efficacy of treatment Day 1 and Last Visit (after at least 180 days of treatment) (1) Changes in PSA and testosterone levels if available, (2) Change in disease symptoms and (3) Objective disease response
Occurrence of Adverse Drug Reactions Day 1 and Last Visit (after at least 180 days of treatment) Changes in quality of life of subjects as measured by EORTC QLQ-C30 Day 1 and Last Visit (after at least 180 days of treatment) European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-C 30 (EORTC-QLQ-C30)
Trial Locations
- Locations (23)
Site: 5
🇧🇪Antwerpen, Antwerp, Belgium
Site: 8
🇧🇪Antwerpen, Antwerp, Belgium
Site: 9
🇧🇪Antwerpen, Antwerp, Belgium
Site: 33
🇧🇪Merksem, Antwerp, Belgium
Site: 1
🇧🇪Turnhout, Antwerp, Belgium
Site: 39
🇧🇪La Louvière, Hainaut, Belgium
Site: 13
🇧🇪Brussel, Brussels Capital Region, Belgium
Site: 24
🇧🇪Uccle, Brussels Capital Region, Belgium
Site: 23
🇧🇪Bruxelles, Brussels Capital Region, Belgium
Site: 37
🇧🇪Sint Truiden, Limburg, Belgium
Site: 11
🇧🇪Gent, East Flanders, Belgium
Site: 17
🇧🇪Oudenaarde, East Flanders, Belgium
Site: 26
🇧🇪Lasne Chapelle Saint Lambert, Walloon Brabant, Belgium
Site: 20
🇧🇪Izegem, West Flanders, Belgium
Site: 4
🇧🇪Antwerpen, Antwerp, Belgium
Site: 14
🇧🇪Antwerpen, Antwerp, Belgium
Site: 18
🇧🇪Tienen, Flemish Brabant, Belgium
Site: 32
🇧🇪Aalst, East Flanders, Belgium
Site: 34
🇧🇪Dendermonde, East Flanders, Belgium
Site: 25
🇧🇪Kortijk, West Flanders, Belgium
Site: 31
🇧🇪Oostende, West Flanders, Belgium
Site: 21
🇧🇪Ieper, West Flanders, Belgium
Site: 38
🇧🇪Liège, Belgium