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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02128334
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

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
Advanced Prostate Carcinoma Drug: Eligard 45 mg Exposure

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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 : September 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Patients with advanced prostate carcinoma Drug: Eligard 45 mg Exposure
Subcutaneous injections
Other Name: leuprorelin acetate




Primary Outcome Measures :
  1. Percentage change in total serum PSA [ Time Frame: Baseline and every 6 months until 24 months after treatment start ]
  2. Percentage change in testosterone levels [ Time Frame: Baseline and every 6 months until 24 months after treatment start ]

Secondary Outcome Measures :
  1. Number of adverse drug reactions [ Time Frame: Baseline to 24 months after treatment start ]
  2. Mean change in QoL based on EuroQOL five dimensions questionnaire (EQ-5D) [ Time Frame: Baseline to 24 months after treatment start ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male patients >18 years of age with advanced prostate cancer (PCa) to whom Eligard 45 mg was prescribed
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128334


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Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
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Principal Investigator: Central Contact Astellas Pharma Europe B.V.

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Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT02128334     History of Changes
Other Study ID Numbers: RU-EGD-NI-001
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Uro-Oncologists
PSA
Eligard
prostate carcinoma

Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents