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

NCT ID: NCT02128334

Last Updated: 2016-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

645 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-03-31

Brief Summary

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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

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Conditions

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Advanced Prostate Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with advanced prostate carcinoma

Eligard 45 mg Exposure

Intervention Type DRUG

Subcutaneous injections

Interventions

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Eligard 45 mg Exposure

Subcutaneous injections

Intervention Type DRUG

Other Intervention Names

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leuprorelin acetate

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: PRINCIPAL_INVESTIGATOR

Astellas Pharma Europe B.V.

Locations

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Site RU34 Private Practice

Abakan, , Russia

Site Status

Site RU23 Private Practice

Anapa, , Russia

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Site RU33 Private Practice

Belgorod, , Russia

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Site RU27 Private Practice

Irkutsk, , Russia

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Site RU29 Private Practice

Irkutsk, , Russia

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Site RU36 Private Practice

Izhevsk, , Russia

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Site RU60 Private Practice

Kostroma, , Russia

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Site RU10 Private Practice

Krasnodar, , Russia

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Site RU12 Private Practice

Krasnodar, , Russia

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Site RU13 Private Practice

Krasnodar, , Russia

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Site RU9 Private Practice

Krasnodar, , Russia

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Site RU35 Private Practice

Kursk, , Russia

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Site RU1 Private Practice

Moscow, , Russia

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Site RU11 Private Practice

Moscow, , Russia

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Site RU14 Private Practice

Moscow, , Russia

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Site RU15 Private Practice

Moscow, , Russia

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Site RU2 Private Practice

Moscow, , Russia

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Site RU20 Private Practice

Moscow, , Russia

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Site RU3 Private Practice

Moscow, , Russia

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Site RU32 Private Practice

Moscow, , Russia

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Site RU4 Private Practice

Moscow, , Russia

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Site RU42 Private Practice

Moscow, , Russia

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Site RU44 Private Practice

Moscow, , Russia

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Site RU55 Private Practice

Moscow, , Russia

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Site RU56 Private Practice

Moscow, , Russia

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Site RU6 Private Practice

Moscow, , Russia

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Site RU61 Private Practice

Moscow, , Russia

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Site RU7 Private Practice

Moscow, , Russia

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Site RU71 Private Practice

Moscow, , Russia

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Site RU72 Private Practice

Moscow, , Russia

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Site RU8 Private Practice

Moscow, , Russia

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Site RU21 Private Practice

Nizhny Novgorod, , Russia

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Site RU63 Private Practice

Nizhny Novgorod, , Russia

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Site RU64 Private Practice

Nizhny Novgorod, , Russia

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Site RU53 Private Practice

Novosibirsk, , Russia

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Site RU30 Private Practice

Omsk, , Russia

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Site RU18 Private Practice

Orenburg, , Russia

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Site RU66 Private Practice

Orenburg, , Russia

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Site RU68 Private Practice

Oryol, , Russia

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Site RU37 Private Practice

Petrozavodsk, , Russia

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Site RU40 Private Practice

Ryazan, , Russia

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Site RU73 Private Practice

Ryazan, , Russia

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Site RU17 Private Practice

Saint Petersburg, , Russia

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Site RU19 Private Practice

Saint Petersburg, , Russia

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Site RU65 Private Practice

Saint Petersburg, , Russia

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Site RU76 Private Practice

Saint Petersburg, , Russia

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Site RU59 Private Practice

Stavropol, , Russia

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Site RU25 Private Practice

Syktyvkar, , Russia

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Site RU54 Private Practice

Tver', , Russia

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Site RU26 Private Practice

Yekaterinburg, , Russia

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Site RU43 Private Practice

Yekaterinburg, , Russia

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Site RU58 Private Practice

Yekaterinburg, , Russia

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Countries

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Russia

Other Identifiers

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RU-EGD-NI-001

Identifier Type: -

Identifier Source: org_study_id

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