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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02128334

Enrollment

645

Registered

2014-05-01

Start date

2013-09-30

Completion date

2016-03-31

Last updated

2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Prostate Carcinoma

Keywords

Uro-Oncologists, PSA, Eligard, prostate carcinoma

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.

Interventions

DRUGEligard 45 mg Exposure

Subcutaneous injections

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percentage change in total serum PSA	Baseline and every 6 months until 24 months after treatment start
Percentage change in testosterone levels	Baseline and every 6 months until 24 months after treatment start

Secondary

Measure	Time frame
Number of adverse drug reactions	Baseline to 24 months after treatment start
Mean change in QoL based on EuroQOL five dimensions questionnaire (EQ-5D)	Baseline to 24 months after treatment start

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026