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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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 ID: NCT02128334

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Site RU34 Private Practice, Abakan, , Russian Federation

Site RU23 Private Practice, Anapa, , Russian Federation

Site RU33 Private Practice, Belgorod, , Russian Federation

Site RU26 Private Practice, Ekaterinburg, , Russian Federation

Site RU43 Private Practice, Ekaterinburg, , Russian Federation

Site RU58 Private Practice, Ekaterinburg, , Russian Federation

Site RU27 Private Practice, Irkutsk, , Russian Federation

Site RU29 Private Practice, Irkutsk, , Russian Federation

Site RU36 Private Practice, Izhevsk, , Russian Federation

Site RU60 Private Practice, Kostroma, , Russian Federation

Site RU10 Private Practice, Krasnodar, , Russian Federation

Site RU12 Private Practice, Krasnodar, , Russian Federation

Site RU13 Private Practice, Krasnodar, , Russian Federation

Site RU9 Private Practice, Krasnodar, , Russian Federation

Site RU35 Private Practice, Kursk, , Russian Federation

Site RU1 Private Practice, Moscow, , Russian Federation

Site RU11 Private Practice, Moscow, , Russian Federation

Site RU14 Private Practice, Moscow, , Russian Federation

Site RU15 Private Practice, Moscow, , Russian Federation

Site RU2 Private Practice, Moscow, , Russian Federation

Site RU20 Private Practice, Moscow, , Russian Federation

Site RU3 Private Practice, Moscow, , Russian Federation

Site RU32 Private Practice, Moscow, , Russian Federation

Site RU4 Private Practice, Moscow, , Russian Federation

Site RU42 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 RU7 Private Practice, Moscow, , Russian Federation

Site RU71 Private Practice, Moscow, , Russian Federation

Site RU72 Private Practice, Moscow, , Russian Federation

Site RU8 Private Practice, Moscow, , Russian Federation

Site RU21 Private Practice, Nizhniy Novgorod, , Russian Federation

Site RU63 Private Practice, Nizhniy Novgorod, , Russian Federation

Site RU64 Private Practice, Nizhniy Novgorod, , Russian Federation

Site RU53 Private Practice, Novosibirsk, , Russian Federation

Site RU30 Private Practice, Omsk, , Russian Federation

Site RU68 Private Practice, Orel, , Russian Federation

Site RU18 Private Practice, Orenburg, , Russian Federation

Site RU66 Private Practice, Orenburg, , Russian Federation

Site RU37 Private Practice, Petrozavodsk, , Russian Federation

Site RU40 Private Practice, Ryazan, , Russian Federation

Site RU73 Private Practice, Ryazan, , Russian Federation

Site RU17 Private Practice, St. Petersburg, , Russian Federation

Site RU19 Private Practice, St. Petersburg, , 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

Contact Details

Name: Central Contact

Affiliation: Astellas Pharma Europe B.V.

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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