An Observational Study Looking at How Well the Drug Eligard Works and How Well it is Tolerated by the Body of Patients With Advanced Prostate Carcinoma in the Russian Federation

Study Overview
=================
Brief Summary
-----------------
Eligard is a 6-month depot injection formulation that combines the active ingredient leuprorelin acetate (LA) with a biodegradable polymer matrix (Atrigel® delivery system). The 6-month (45 mg) formulation was approved for the Russian market in 2009. It has been shown to reduce testosterone and prostate-specific antigen (PSA) levels and to be well tolerated in several clinical trials. However, clinical trials are limited by strict patient inclusion and exclusion criteria. Therefore, the current non-interventional study aimed at investigating whether the efficacy and tolerability of the 6-month LA depot formulation could also be confirmed in a broad and heterogeneous patient population encountered in daily clinical practice in the Russian Federation. This study will evaluate total serum PSA and testosterone levels, Quality of Life (QoL) of patients, demographic patient data, diagnosis and diagnostic findings in patients. It will provide analysis in different subgroups of patients depending on previous hormonal treatment and anamnesis of disease.

Official Title
-----------------
Prospective Multicenter Observational Program for Evaluation of Efficacy and Tolerability of the 6-month Depot Eligard 45 mg in Patients With Advanced Prostate Carcinoma in Routine Clinical Practice of Uro-Oncologists in the Russian Federation

Conditions
-----------------
Advanced Prostate Carcinoma

Intervention / Treatment
-----------------
* Drug: Eligard 45 mg Exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All male patients > 18 years of age with advanced PCa to whom oncourologist decided to prescribe Eligard 45 mg Exclusion Criteria: Patient participation in any clinical trials.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with advanced prostate carcinoma<br> | Drug: Eligard 45 mg Exposure<br>* Subcutaneous injections<br>* Other names: leuprorelin acetate;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in total serum PSA |  | Baseline and every 6 months until 24 months after treatment start | 
| Percentage change in testosterone levels |  | Baseline and every 6 months until 24 months after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse drug reactions |  | Baseline to 24 months after treatment start | 
| Mean change in QoL based on EuroQOL five dimensions questionnaire (EQ-5D) |  | Baseline to 24 months after treatment start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PSA, Uro-Oncologists, Eligard, prostate carcinoma