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.
Study Type
OBSERVATIONAL
Enrollment
645
Subcutaneous injections
Site RU34 Private Practice
Abakan, Russia
Site RU23 Private Practice
Anapa, Russia
Site RU33 Private Practice
Belgorod, Russia
Site RU27 Private Practice
Irkutsk, Russia
Site RU29 Private Practice
Irkutsk, Russia
Site RU36 Private Practice
Percentage change in total serum PSA
Time frame: Baseline and every 6 months until 24 months after treatment start
Percentage change in testosterone levels
Time frame: Baseline and every 6 months until 24 months after treatment start
Number of adverse drug reactions
Time frame: Baseline to 24 months after treatment start
Mean change in QoL based on EuroQOL five dimensions questionnaire (EQ-5D)
Time frame: Baseline to 24 months after treatment start
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Izhevsk, Russia
Site RU60 Private Practice
Kostroma, Russia
Site RU10 Private Practice
Krasnodar, Russia
Site RU12 Private Practice
Krasnodar, Russia
Site RU13 Private Practice
Krasnodar, Russia
...and 42 more locations