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
- Registration Number
- NCT02128334
- Lead Sponsor
- Astellas Pharma Europe B.V.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 645
- All male patients > 18 years of age with advanced PCa to whom oncourologist decided to prescribe Eligard 45 mg
- Patient participation in any clinical trials.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with advanced prostate carcinoma Eligard 45 mg Exposure -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (52)
Site RU23 Private Practice
🇷🇺Anapa, Russian Federation
Site RU26 Private Practice
🇷🇺Ekaterinburg, Russian Federation
Site RU43 Private Practice
🇷🇺Ekaterinburg, Russian Federation
Site RU58 Private Practice
🇷🇺Ekaterinburg, Russian Federation
Site RU9 Private Practice
🇷🇺Krasnodar, Russian Federation
Site RU35 Private Practice
🇷🇺Kursk, Russian Federation
Site RU4 Private Practice
🇷🇺Moscow, Russian Federation
Site RU14 Private Practice
🇷🇺Moscow, Russian Federation
Site RU1 Private Practice
🇷🇺Moscow, Russian Federation
Site RU15 Private Practice
🇷🇺Moscow, Russian Federation
Site RU20 Private Practice
🇷🇺Moscow, Russian Federation
Site RU3 Private Practice
🇷🇺Moscow, Russian Federation
Site RU44 Private Practice
🇷🇺Moscow, Russian Federation
Site RU55 Private Practice
🇷🇺Moscow, Russian Federation
Site RU56 Private Practice
🇷🇺Moscow, Russian Federation
Site RU6 Private Practice
🇷🇺Moscow, Russian Federation
Site RU61 Private Practice
🇷🇺Moscow, Russian Federation
Site RU72 Private Practice
🇷🇺Moscow, Russian Federation
Site RU71 Private Practice
🇷🇺Moscow, Russian Federation
Site RU21 Private Practice
🇷🇺Nizhniy Novgorod, Russian Federation
Site RU64 Private Practice
🇷🇺Nizhniy Novgorod, Russian Federation
Site RU30 Private Practice
🇷🇺Omsk, Russian Federation
Site RU68 Private Practice
🇷🇺Orel, Russian Federation
Site RU65 Private Practice
🇷🇺St. Petersburg, Russian Federation
Site RU76 Private Practice
🇷🇺St. Petersburg, Russian Federation
Site RU59 Private Practice
🇷🇺Stavropol, Russian Federation
Site RU25 Private Practice
🇷🇺Syktyvkar, Russian Federation
Site RU54 Private Practice
🇷🇺Tver, Russian Federation
Site RU10 Private Practice
🇷🇺Krasnodar, Russian Federation
Site RU18 Private Practice
🇷🇺Orenburg, Russian Federation
Site RU42 Private Practice
🇷🇺Moscow, Russian Federation
Site RU7 Private Practice
🇷🇺Moscow, Russian Federation
Site RU13 Private Practice
🇷🇺Krasnodar, Russian Federation
Site RU63 Private Practice
🇷🇺Nizhniy Novgorod, Russian Federation
Site RU33 Private Practice
🇷🇺Belgorod, Russian Federation
Site RU27 Private Practice
🇷🇺Irkutsk, Russian Federation
Site RU60 Private Practice
🇷🇺Kostroma, Russian Federation
Site RU19 Private Practice
🇷🇺St. Petersburg, Russian Federation
Site RU2 Private Practice
🇷🇺Moscow, Russian Federation
Site RU36 Private Practice
🇷🇺Izhevsk, Russian Federation
Site RU12 Private Practice
🇷🇺Krasnodar, Russian Federation
Site RU66 Private Practice
🇷🇺Orenburg, Russian Federation
Site RU73 Private Practice
🇷🇺Ryazan, Russian Federation
Site RU17 Private Practice
🇷🇺St. Petersburg, Russian Federation
Site RU32 Private Practice
🇷🇺Moscow, Russian Federation
Site RU8 Private Practice
🇷🇺Moscow, Russian Federation
Site RU34 Private Practice
🇷🇺Abakan, Russian Federation
Site RU29 Private Practice
🇷🇺Irkutsk, Russian Federation
Site RU53 Private Practice
🇷🇺Novosibirsk, Russian Federation
Site RU37 Private Practice
🇷🇺Petrozavodsk, Russian Federation
Site RU40 Private Practice
🇷🇺Ryazan, Russian Federation
Site RU11 Private Practice
🇷🇺Moscow, Russian Federation