Prostate Cancer
Conditions
Keywords
Prostate Cancer, Phase 4, Data collection, Observational, Depo-Eligard, Prospective, Non-interventional, Treatment
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.
Interventions
DRUGDepo-Eligard®
Subcutaneous
Sponsors
Veeda Clinical Research
Astellas Pharma Europe B.V.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Patients having been prescribed Depo-Eligard® 7.5 mg - 22.5 mg - 45 mg in accordance with the terms of the marketing authorization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of tolerability of treatment on a 4 point scale | Last Visit (after at least 180 days of treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Drug Reactions | Day 1 and Last Visit (after at least 180 days of treatment) | — |
| 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) | — |
| 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) |
| 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 |
Countries
Belgium
Outcome results
None listed