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
1 other identifier
observational
645
1 country
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2013
Typical duration for all trials
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 29, 2014
CompletedFirst Posted
Study publicly available on registry
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedAugust 16, 2016
August 1, 2016
2.5 years
April 29, 2014
August 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Study Arms (1)
Patients with advanced prostate carcinoma
Interventions
Subcutaneous injections
Eligibility Criteria
Male patients \>18 years of age with advanced prostate cancer (PCa) to whom Eligard 45 mg was prescribed
You may qualify if:
- All male patients \> 18 years of age with advanced PCa to whom oncourologist decided to prescribe Eligard 45 mg
You may not qualify if:
- Patient participation in any clinical trials.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Site RU34 Private Practice
Abakan, Russia
Site RU23 Private Practice
Anapa, Russia
Site RU33 Private Practice
Belgorod, Russia
Site RU27 Private Practice
Irkutsk, Russia
Site RU29 Private Practice
Irkutsk, Russia
Site RU36 Private Practice
Izhevsk, Russia
Site RU60 Private Practice
Kostroma, Russia
Site RU10 Private Practice
Krasnodar, Russia
Site RU12 Private Practice
Krasnodar, Russia
Site RU13 Private Practice
Krasnodar, Russia
Site RU9 Private Practice
Krasnodar, Russia
Site RU35 Private Practice
Kursk, Russia
Site RU1 Private Practice
Moscow, Russia
Site RU11 Private Practice
Moscow, Russia
Site RU14 Private Practice
Moscow, Russia
Site RU15 Private Practice
Moscow, Russia
Site RU2 Private Practice
Moscow, Russia
Site RU20 Private Practice
Moscow, Russia
Site RU3 Private Practice
Moscow, Russia
Site RU32 Private Practice
Moscow, Russia
Site RU4 Private Practice
Moscow, Russia
Site RU42 Private Practice
Moscow, Russia
Site RU44 Private Practice
Moscow, Russia
Site RU55 Private Practice
Moscow, Russia
Site RU56 Private Practice
Moscow, Russia
Site RU6 Private Practice
Moscow, Russia
Site RU61 Private Practice
Moscow, Russia
Site RU7 Private Practice
Moscow, Russia
Site RU71 Private Practice
Moscow, Russia
Site RU72 Private Practice
Moscow, Russia
Site RU8 Private Practice
Moscow, Russia
Site RU21 Private Practice
Nizhny Novgorod, Russia
Site RU63 Private Practice
Nizhny Novgorod, Russia
Site RU64 Private Practice
Nizhny Novgorod, Russia
Site RU53 Private Practice
Novosibirsk, Russia
Site RU30 Private Practice
Omsk, Russia
Site RU18 Private Practice
Orenburg, Russia
Site RU66 Private Practice
Orenburg, Russia
Site RU68 Private Practice
Oryol, Russia
Site RU37 Private Practice
Petrozavodsk, Russia
Site RU40 Private Practice
Ryazan, Russia
Site RU73 Private Practice
Ryazan, Russia
Site RU17 Private Practice
Saint Petersburg, Russia
Site RU19 Private Practice
Saint Petersburg, Russia
Site RU65 Private Practice
Saint Petersburg, Russia
Site RU76 Private Practice
Saint Petersburg, Russia
Site RU59 Private Practice
Stavropol, Russia
Site RU25 Private Practice
Syktyvkar, Russia
Site RU54 Private Practice
Tver', Russia
Site RU26 Private Practice
Yekaterinburg, Russia
Site RU43 Private Practice
Yekaterinburg, Russia
Site RU58 Private Practice
Yekaterinburg, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Central Contact
Astellas Pharma Europe B.V.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2014
First Posted
May 1, 2014
Study Start
September 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
August 16, 2016
Record last verified: 2016-08