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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Depo-Eligard®


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate Cancer patients<br> | Drug: Depo-Eligard®<br>* Subcutaneous<br>* Other names: Leuprolide Acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of tolerability of treatment on a 4 point scale |  | Last Visit (after at least 180 days of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-C 30 (EORTC-QLQ-C30) | Day 1 and 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 | (1) Changes in PSA and testosterone levels if available, (2) Change in disease symptoms and (3) Objective disease response | Day 1 and Last Visit (after at least 180 days of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Phase 4, Data collection, Observational, Depo-Eligard, Prospective, Non-interventional, Treatment