Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eligard 45 mg Exposure | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with advanced prostate carcinoma
- interventionNames
- Drug: Eligard 45 mg Exposure
Primary outcomes (2)
- measure
- Percentage change in total serum PSA
- timeFrame
- Baseline and every 6 months until 24 months after treatment start
- measure
- Percentage change in testosterone levels
- timeFrame
- Baseline and every 6 months until 24 months after treatment start
Secondary outcomes (2)
- measure
- Number of adverse drug reactions
- timeFrame
- Baseline to 24 months after treatment start
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available