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

August 15, 2016 updated by: Astellas Pharma Europe B.V.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

645

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Abakan, Russian Federation
        • Site RU34 Private Practice
      • Anapa, Russian Federation
        • Site RU23 Private Practice
      • Belgorod, Russian Federation
        • Site RU33 Private Practice
      • Ekaterinburg, Russian Federation
        • Site RU26 Private Practice
      • Ekaterinburg, Russian Federation
        • Site RU43 Private Practice
      • Ekaterinburg, Russian Federation
        • Site RU58 Private Practice
      • Irkutsk, Russian Federation
        • Site RU27 Private Practice
      • Irkutsk, Russian Federation
        • Site RU29 Private Practice
      • Izhevsk, Russian Federation
        • Site RU36 Private Practice
      • Kostroma, Russian Federation
        • Site RU60 Private Practice
      • Krasnodar, 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
      • Kursk, Russian Federation
        • Site RU35 Private Practice
      • Moscow, 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
      • Nizhniy Novgorod, Russian Federation
        • Site RU21 Private Practice
      • Nizhniy Novgorod, Russian Federation
        • Site RU63 Private Practice
      • Nizhniy Novgorod, Russian Federation
        • Site RU64 Private Practice
      • Novosibirsk, Russian Federation
        • Site RU53 Private Practice
      • Omsk, Russian Federation
        • Site RU30 Private Practice
      • Orel, Russian Federation
        • Site RU68 Private Practice
      • Orenburg, Russian Federation
        • Site RU18 Private Practice
      • Orenburg, Russian Federation
        • Site RU66 Private Practice
      • Petrozavodsk, Russian Federation
        • Site RU37 Private Practice
      • Ryazan, Russian Federation
        • Site RU40 Private Practice
      • Ryazan, Russian Federation
        • Site RU73 Private Practice
      • St. Petersburg, 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
      • Stavropol, Russian Federation
        • Site RU59 Private Practice
      • Syktyvkar, Russian Federation
        • Site RU25 Private Practice
      • Tver, Russian Federation
        • Site RU54 Private Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Male patients >18 years of age with advanced prostate cancer (PCa) to whom Eligard 45 mg was prescribed

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with advanced prostate carcinoma
Drug: Eligard 45 mg Exposure
Subcutaneous injections
Other Names:
  • leuprorelin acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change in total serum PSA
Time Frame: Baseline and every 6 months until 24 months after treatment start
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
Baseline and every 6 months until 24 months after treatment start

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of adverse drug reactions
Time Frame: Baseline to 24 months after treatment start
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
Baseline to 24 months after treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Europe B.V.

Investigators

  • Principal Investigator: Central Contact, Astellas Pharma Europe B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RU-EGD-NI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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