Clinical trial NCT00811876: Retrospective, Non-interventional Study of Depo-Eligard®.
Official title: Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-interventional Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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 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

Primary outcomes:
measure: Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard®
timeFrame: After at least 6 months treatment with Depo-Eligard
Secondary outcomes:
measure: Measurement of PSA and testosterone levels if available
timeFrame: After at least 6 months treatment with Depo-Eligard
measure: Overall evaluation of efficacy
timeFrame: After a least 6 months treatment with Depo-Eligard
measure: Overall patient assessment of treatment benefit
timeFrame: After at least 6 months treatment with Depo-Eligard
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Berlaar
country: Belgium
city: Bornem
country: Belgium
city: Brussels
country: Belgium
city: Brussels
country: Belgium
city: Brussels
country: Belgium
city: Charleroi
country: Belgium
city: Gent
country: Belgium
city: Jemeppe
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Lommel
country: Belgium
city: Merksem
country: Belgium
city: Mons
country: Belgium
city: Mortsel
country: Belgium
city: Ragnies
country: Belgium
city: Tienen
country: Belgium
city: Tongeren
country: Belgium
city: Turnhout
country: Belgium
city: Waregem
country: Belgium
city: Willebroek
country: Belgium
city: Yvoir
country: Belgium
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_DIRECTOR
References: