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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

NCT02128334 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 645

Last updated 2016-08-16

No results posted yet for this study

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.

Conditions

  • Advanced Prostate Carcinoma

Interventions

DRUG

Eligard 45 mg Exposure

Subcutaneous injections

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Central Contact · Astellas Pharma Europe B.V.

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02128334 on ClinicalTrials.gov