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Retrospective, Non-interventional Study of Depo-Eligard®.

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Data Collection on Depo-Eligard exposure (Other)

Phase: N/A

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma Europe B.V.

Summary

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

Clinical Details

Official title: Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-interventional Clinical Trial

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard®

Secondary outcome:

Measurement of PSA and testosterone levels if available

Overall evaluation of efficacy

Overall patient assessment of treatment benefit

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Antwerpen 2060, Belgium

Berlaar 2590, Belgium

Bornem 2880, Belgium

Brussels 1020, Belgium

Brussels 1070, Belgium

Brussels 1090, Belgium

Charleroi 6000, Belgium

Gent 9000, Belgium

Jemeppe 4101, Belgium

Kortrijk 8500, Belgium

Leuven 3000, Belgium

Liege 4000, Belgium

Lommel 3290, Belgium

Merksem 2170, Belgium

Mons 7000, Belgium

Mortsel 2640, Belgium

Ragnies 6532, Belgium

Tienen 3300, Belgium

Tongeren 3700, Belgium

Turnhout 2300, Belgium

Waregem 8790, Belgium

Willebroek 2830, Belgium

Yvoir 5530, Belgium

Additional Information

Starting date: September 2008
Last updated: January 21, 2010

Page last updated: August 23, 2015

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