Clinical trial NCT02128334: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Prostate Carcinoma
Keywords: Uro-Oncologists
PSA
Eligard
prostate carcinoma
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-05-01
Enrollment: 645
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male patients \>18 years of age with advanced prostate cancer (PCa) to whom Eligard 45 mg was prescribed

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.


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.

Primary outcomes:
measure: Percentage change in total serum PSA
timeFrame: Baseline and every 6 months until 24 months after treatment start
measure: Percentage change in testosterone levels
timeFrame: Baseline and every 6 months until 24 months after treatment start
Secondary outcomes:
measure: Number of adverse drug reactions
timeFrame: Baseline to 24 months after treatment start
measure: Mean change in QoL based on EuroQOL five dimensions questionnaire (EQ-5D)
timeFrame: Baseline to 24 months after treatment start
Other outcomes:
Locations:
city: Abakan
country: Russian Federation
facility: Site RU34 Private Practice
city: Anapa
country: Russian Federation
facility: Site RU23 Private Practice
city: Belgorod
country: Russian Federation
facility: Site RU33 Private Practice
city: Ekaterinburg
country: Russian Federation
facility: Site RU26 Private Practice
city: Ekaterinburg
country: Russian Federation
facility: Site RU43 Private Practice
city: Ekaterinburg
country: Russian Federation
facility: Site RU58 Private Practice
city: Irkutsk
country: Russian Federation
facility: Site RU27 Private Practice
city: Irkutsk
country: Russian Federation
facility: Site RU29 Private Practice
city: Izhevsk
country: Russian Federation
facility: Site RU36 Private Practice
city: Kostroma
country: Russian Federation
facility: Site RU60 Private Practice
city: Krasnodar
country: Russian Federation
facility: Site RU10 Private Practice
city: Krasnodar
country: Russian Federation
facility: Site RU12 Private Practice
city: Krasnodar
country: Russian Federation
facility: Site RU13 Private Practice
city: Krasnodar
country: Russian Federation
facility: Site RU9 Private Practice
city: Kursk
country: Russian Federation
facility: Site RU35 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU1 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU11 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU14 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU15 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU2 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU20 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU3 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU32 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU4 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU42 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU44 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU55 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU56 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU6 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU61 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU7 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU71 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU72 Private Practice
city: Moscow
country: Russian Federation
facility: Site RU8 Private Practice
city: Nizhniy Novgorod
country: Russian Federation
facility: Site RU21 Private Practice
city: Nizhniy Novgorod
country: Russian Federation
facility: Site RU63 Private Practice
city: Nizhniy Novgorod
country: Russian Federation
facility: Site RU64 Private Practice
city: Novosibirsk
country: Russian Federation
facility: Site RU53 Private Practice
city: Omsk
country: Russian Federation
facility: Site RU30 Private Practice
city: Orel
country: Russian Federation
facility: Site RU68 Private Practice
city: Orenburg
country: Russian Federation
facility: Site RU18 Private Practice
city: Orenburg
country: Russian Federation
facility: Site RU66 Private Practice
city: Petrozavodsk
country: Russian Federation
facility: Site RU37 Private Practice
city: Ryazan
country: Russian Federation
facility: Site RU40 Private Practice
city: Ryazan
country: Russian Federation
facility: Site RU73 Private Practice
city: St. Petersburg
country: Russian Federation
facility: Site RU17 Private Practice
city: St. Petersburg
country: Russian Federation
facility: Site RU19 Private Practice
city: St. Petersburg
country: Russian Federation
facility: Site RU65 Private Practice
city: St. Petersburg
country: Russian Federation
facility: Site RU76 Private Practice
city: Stavropol
country: Russian Federation
facility: Site RU59 Private Practice
city: Syktyvkar
country: Russian Federation
facility: Site RU25 Private Practice
city: Tver
country: Russian Federation
facility: Site RU54 Private Practice
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: PRINCIPAL_INVESTIGATOR
References: