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
Sponsor
Astellas Pharma Europe B.V. (Industry)
Overall Status
Completed
CT.gov ID
NCT02128334
Collaborator
(none)
645
52
30
12.4
0.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
645 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Study Start Date
:
Sep 1, 2013
Actual Primary Completion Date
:
Mar 1, 2016
Actual Study Completion Date
:
Mar 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with advanced prostate carcinoma
|
Drug: Eligard 45 mg Exposure
Subcutaneous injections
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site RU34 Private Practice | Abakan | Russian Federation | ||
| 2 | Site RU23 Private Practice | Anapa | Russian Federation | ||
| 3 | Site RU33 Private Practice | Belgorod | Russian Federation | ||
| 4 | Site RU26 Private Practice | Ekaterinburg | Russian Federation | ||
| 5 | Site RU43 Private Practice | Ekaterinburg | Russian Federation | ||
| 6 | Site RU58 Private Practice | Ekaterinburg | Russian Federation | ||
| 7 | Site RU27 Private Practice | Irkutsk | Russian Federation | ||
| 8 | Site RU29 Private Practice | Irkutsk | Russian Federation | ||
| 9 | Site RU36 Private Practice | Izhevsk | Russian Federation | ||
| 10 | Site RU60 Private Practice | Kostroma | Russian Federation | ||
| 11 | Site RU10 Private Practice | Krasnodar | Russian Federation | ||
| 12 | Site RU12 Private Practice | Krasnodar | Russian Federation | ||
| 13 | Site RU13 Private Practice | Krasnodar | Russian Federation | ||
| 14 | Site RU9 Private Practice | Krasnodar | Russian Federation | ||
| 15 | Site RU35 Private Practice | Kursk | Russian Federation | ||
| 16 | Site RU1 Private Practice | Moscow | Russian Federation | ||
| 17 | Site RU11 Private Practice | Moscow | Russian Federation | ||
| 18 | Site RU14 Private Practice | Moscow | Russian Federation | ||
| 19 | Site RU15 Private Practice | Moscow | Russian Federation | ||
| 20 | Site RU2 Private Practice | Moscow | Russian Federation | ||
| 21 | Site RU20 Private Practice | Moscow | Russian Federation | ||
| 22 | Site RU3 Private Practice | Moscow | Russian Federation | ||
| 23 | Site RU32 Private Practice | Moscow | Russian Federation | ||
| 24 | Site RU4 Private Practice | Moscow | Russian Federation | ||
| 25 | Site RU42 Private Practice | Moscow | Russian Federation | ||
| 26 | Site RU44 Private Practice | Moscow | Russian Federation | ||
| 27 | Site RU55 Private Practice | Moscow | Russian Federation | ||
| 28 | Site RU56 Private Practice | Moscow | Russian Federation | ||
| 29 | Site RU6 Private Practice | Moscow | Russian Federation | ||
| 30 | Site RU61 Private Practice | Moscow | Russian Federation | ||
| 31 | Site RU7 Private Practice | Moscow | Russian Federation | ||
| 32 | Site RU71 Private Practice | Moscow | Russian Federation | ||
| 33 | Site RU72 Private Practice | Moscow | Russian Federation | ||
| 34 | Site RU8 Private Practice | Moscow | Russian Federation | ||
| 35 | Site RU21 Private Practice | Nizhniy Novgorod | Russian Federation | ||
| 36 | Site RU63 Private Practice | Nizhniy Novgorod | Russian Federation | ||
| 37 | Site RU64 Private Practice | Nizhniy Novgorod | Russian Federation | ||
| 38 | Site RU53 Private Practice | Novosibirsk | Russian Federation | ||
| 39 | Site RU30 Private Practice | Omsk | Russian Federation | ||
| 40 | Site RU68 Private Practice | Orel | Russian Federation | ||
| 41 | Site RU18 Private Practice | Orenburg | Russian Federation | ||
| 42 | Site RU66 Private Practice | Orenburg | Russian Federation | ||
| 43 | Site RU37 Private Practice | Petrozavodsk | Russian Federation | ||
| 44 | Site RU40 Private Practice | Ryazan | Russian Federation | ||
| 45 | Site RU73 Private Practice | Ryazan | Russian Federation | ||
| 46 | Site RU17 Private Practice | St. Petersburg | Russian Federation | ||
| 47 | Site RU19 Private Practice | St. Petersburg | Russian Federation | ||
| 48 | Site RU65 Private Practice | St. Petersburg | Russian Federation | ||
| 49 | Site RU76 Private Practice | St. Petersburg | Russian Federation | ||
| 50 | Site RU59 Private Practice | Stavropol | Russian Federation | ||
| 51 | Site RU25 Private Practice | Syktyvkar | Russian Federation | ||
| 52 | Site RU54 Private Practice | Tver | Russian Federation |
Sponsors and Collaborators
- Astellas Pharma Europe B.V.
Investigators
- Principal Investigator: Central Contact, Astellas Pharma Europe B.V.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier:
NCT02128334
Other Study ID Numbers:
- RU-EGD-NI-001
First Posted:
May 1, 2014
Last Update Posted:
Aug 16, 2016
Last Verified:
Aug 1, 2016
Keywords provided by Astellas Pharma Europe B.V.
Additional relevant MeSH terms: