Retrospective, Non-interventional Study of Depo-Eligard®. - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00811876

Purpose

Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of treatment

Condition	Intervention
Prostate Cancer	Other: Data Collection on Depo-Eligard exposure

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-interventional Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Leuprolide Leuprolide acetate

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard® [ Time Frame: After at least 6 months treatment with Depo-Eligard ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measurement of PSA and testosterone levels if available [ Time Frame: After at least 6 months treatment with Depo-Eligard ] [ Designated as safety issue: No ]
Overall evaluation of efficacy [ Time Frame: After a least 6 months treatment with Depo-Eligard ] [ Designated as safety issue: No ]
Overall patient assessment of treatment benefit [ Time Frame: After at least 6 months treatment with Depo-Eligard ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	140
Study Start Date:	September 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Retrospective, Non-interventional

Detailed Description:

The study will provide data on the tolerance, safety and acceptance of Depo-Eligard® (leuproreline acetate) when used in routine clinical practice. Data on efficacy parameters such as testosterone, PSA levels, symptoms and treatment failure, if available will be collected.It will reflect the way Depo-Eligard® is used in routine clinical practice and how PSA, testosterone levels, symptoms and treatment failure, are used as parameters in the treatment for Prostate Cancer.

Patient data will be collected after a treatment period of six months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients from Belgian participating investigator sites having been prescribed Depo-Eligard® in accordance with the terms of the marketing authorization, on treatment with Depo-Eligard® for at least six months.

Criteria

Inclusion Criteria:

Patients having been prescribed Depo-Eligard® in accordance with the terms of the marketing authorization
Patients on treatment with Depo-Eligard® for at least six months
Written consent has been obtained

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811876

Locations

Belgium

Antwerpen, Belgium, 2060

Berlaar, Belgium, 2590

Bornem, Belgium, 2880

Brussels, Belgium, 1090

Brussels, Belgium, 1020

Brussels, Belgium, 1070

Charleroi, Belgium, 6000

Gent, Belgium, 9000

Jemeppe, Belgium, 4101

Kortrijk, Belgium, 8500

Leuven, Belgium, 3000

Yvoir, Belgium, 5530

Lommel, Belgium, 3290

Merksem, Belgium, 2170

Mons, Belgium, 7000

Mortsel, Belgium, 2640

Ragnies, Belgium, 6532

Tienen, Belgium, 3300

Tongeren, Belgium, 3700

Turnhout, Belgium, 2300

Waregem, Belgium, 8790

Willebroek, Belgium, 2830

Liege, Belgium, 4000

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma Europe BV

More Information

No publications provided

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	BE-08-EGD-02
Study First Received:	December 17, 2008
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00811876 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Astellas Pharma Inc:

Prostate cancer

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Reproductive Control Agents
Genital Diseases, Male

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Leuprolide
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010