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

Prostate Cancer Clinical Trial

— OCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811876
• Other study ID #: BE-08-EGD-02
• Status: Completed
• Phase: N/A
• First received: December 17, 2008
• Last updated: January 21, 2010
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Data Collection on Depo-Eligard exposure
Retrospective, Non-interventional

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Measurement of PSA and testosterone levels if available		After at least 6 months treatment with Depo-Eligard	No
Secondary	Overall evaluation of efficacy		After a least 6 months treatment with Depo-Eligard	No
Secondary	Overall patient assessment of treatment benefit		After at least 6 months treatment with Depo-Eligard	No