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

Advanced Prostate Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128334
• Other study ID #: RU-EGD-NI-001
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: August 15, 2016
• Start date: September 2013
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 645
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Prostate Carcinoma
• Carcinoma
• Prostatic Neoplasms

Intervention

Drug:
• Eligard 45 mg Exposure
Subcutaneous injections

Locations

Country	Name	City	State
Russian Federation	Site RU34 Private Practice	Abakan
Russian Federation	Site RU23 Private Practice	Anapa
Russian Federation	Site RU33 Private Practice	Belgorod
Russian Federation	Site RU26 Private Practice	Ekaterinburg
Russian Federation	Site RU43 Private Practice	Ekaterinburg
Russian Federation	Site RU58 Private Practice	Ekaterinburg
Russian Federation	Site RU27 Private Practice	Irkutsk
Russian Federation	Site RU29 Private Practice	Irkutsk
Russian Federation	Site RU36 Private Practice	Izhevsk
Russian Federation	Site RU60 Private Practice	Kostroma
Russian Federation	Site RU10 Private Practice	Krasnodar
Russian Federation	Site RU12 Private Practice	Krasnodar
Russian Federation	Site RU13 Private Practice	Krasnodar
Russian Federation	Site RU9 Private Practice	Krasnodar
Russian Federation	Site RU35 Private Practice	Kursk
Russian Federation	Site RU1 Private Practice	Moscow
Russian Federation	Site RU11 Private Practice	Moscow
Russian Federation	Site RU14 Private Practice	Moscow
Russian Federation	Site RU15 Private Practice	Moscow
Russian Federation	Site RU2 Private Practice	Moscow
Russian Federation	Site RU20 Private Practice	Moscow
Russian Federation	Site RU3 Private Practice	Moscow
Russian Federation	Site RU32 Private Practice	Moscow
Russian Federation	Site RU4 Private Practice	Moscow
Russian Federation	Site RU42 Private Practice	Moscow
Russian Federation	Site RU44 Private Practice	Moscow
Russian Federation	Site RU55 Private Practice	Moscow
Russian Federation	Site RU56 Private Practice	Moscow
Russian Federation	Site RU6 Private Practice	Moscow
Russian Federation	Site RU61 Private Practice	Moscow
Russian Federation	Site RU7 Private Practice	Moscow
Russian Federation	Site RU71 Private Practice	Moscow
Russian Federation	Site RU72 Private Practice	Moscow
Russian Federation	Site RU8 Private Practice	Moscow
Russian Federation	Site RU21 Private Practice	Nizhniy Novgorod
Russian Federation	Site RU63 Private Practice	Nizhniy Novgorod
Russian Federation	Site RU64 Private Practice	Nizhniy Novgorod
Russian Federation	Site RU53 Private Practice	Novosibirsk
Russian Federation	Site RU30 Private Practice	Omsk
Russian Federation	Site RU68 Private Practice	Orel
Russian Federation	Site RU18 Private Practice	Orenburg
Russian Federation	Site RU66 Private Practice	Orenburg
Russian Federation	Site RU37 Private Practice	Petrozavodsk
Russian Federation	Site RU40 Private Practice	Ryazan
Russian Federation	Site RU73 Private Practice	Ryazan
Russian Federation	Site RU17 Private Practice	St. Petersburg
Russian Federation	Site RU19 Private Practice	St. Petersburg
Russian Federation	Site RU65 Private Practice	St. Petersburg
Russian Federation	Site RU76 Private Practice	St. Petersburg
Russian Federation	Site RU59 Private Practice	Stavropol
Russian Federation	Site RU25 Private Practice	Syktyvkar
Russian Federation	Site RU54 Private Practice	Tver

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in total serum PSA		Baseline and every 6 months until 24 months after treatment start	No
Primary	Percentage change in testosterone levels		Baseline and every 6 months until 24 months after treatment start	No
Secondary	Number of adverse drug reactions		Baseline to 24 months after treatment start	No
Secondary	Mean change in QoL based on EuroQOL five dimensions questionnaire (EQ-5D)		Baseline to 24 months after treatment start	No