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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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advanced Prostate Carcinoma

Intervention: Eligard 45 mg Exposure (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Astellas Pharma Europe B.V.

Official(s) and/or principal investigator(s):
Central Contact, Principal Investigator, Affiliation: Astellas Pharma Europe B.V.

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.

Clinical Details

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 design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Percentage change in total serum PSA

Percentage change in testosterone levels

Secondary outcome:

Number of adverse drug reactions

Mean change in QoL based on EuroQOL five dimensions questionnaire (EQ-5D)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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.

Locations and Contacts

Site: 34, Abakan, Russian Federation

Site: 23, Anapa, Russian Federation

Site: 33, Belgorod, Russian Federation

Site: 26, Ekaterinburg, Russian Federation

Site: 43, Ekaterinburg, Russian Federation

Site: 58, Ekaterinburg, Russian Federation

Site: 27, Irkutsk, Russian Federation

Site: 29, Irkutsk, Russian Federation

Site: 36, Izhevsk, Russian Federation

Site: 60, Kostroma, Russian Federation

Site: 10, Krasnodar, Russian Federation

Site: 12, Krasnodar, Russian Federation

Site: 13, Krasnodar, Russian Federation

Site: 9, Krasnodar, Russian Federation

Site: 35, Kursk, Russian Federation

Site: 1, Moscow, Russian Federation

Site: 11, Moscow, Russian Federation

Site: 14, Moscow, Russian Federation

Site: 15, Moscow, Russian Federation

Site: 2, Moscow, Russian Federation

Site: 20, Moscow, Russian Federation

Site: 3, Moscow, Russian Federation

Site: 32, Moscow, Russian Federation

Site: 4, Moscow, Russian Federation

Site: 42, Moscow, Russian Federation

Site: 44, Moscow, Russian Federation

Site: 55, Moscow, Russian Federation

Site: 56, Moscow, Russian Federation

Site: 6, Moscow, Russian Federation

Site: 61, Moscow, Russian Federation

Site: 7, Moscow, Russian Federation

Site: 71, Moscow, Russian Federation

Site: 72, Moscow, Russian Federation

Site: 8, Moscow, Russian Federation

Site: 21, Nizhniy Novgorod, Russian Federation

Site: 63, Nizhniy Novgorod, Russian Federation

Site: 64, Nizhniy Novgorod, Russian Federation

Site: 53, Novosibirsk, Russian Federation

Site: 30, Omsk, Russian Federation

Site: 68, Orel, Russian Federation

Site: 18, Orenburg, Russian Federation

Site: 66, Orenburg, Russian Federation

Site: 37, Petrozavodsk, Russian Federation

Site: 40, Ryazan, Russian Federation

Site: 73, Ryazan, Russian Federation

Site: 17, St. Petersburg, Russian Federation

Site: 19, St. Petersburg, Russian Federation

Site: 65, St. Petersburg, Russian Federation

Site: 76, St. Petersburg, Russian Federation

Site: 59, Stavropol, Russian Federation

Site: 25, Syktyvkar, Russian Federation

Site: 54, Tver, Russian Federation

Additional Information

Starting date: September 2013
Last updated: July 21, 2015

Page last updated: August 23, 2015

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