Retrospective, Non-interventional Study of Depo-Eligard®.
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT00811876
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 140
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard® After at least 6 months treatment with Depo-Eligard
- Secondary Outcome Measures
Name Time Method Measurement of PSA and testosterone levels if available After at least 6 months treatment with Depo-Eligard Overall evaluation of efficacy After a least 6 months treatment with Depo-Eligard Overall patient assessment of treatment benefit After at least 6 months treatment with Depo-Eligard