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OpenTrials
Completed

NCT Number: NCT00811876

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection on Depo-Eligard exposure

Other

Retrospective, Non-interventional

Other names: leuproreline acetate exposure

Primary outcomes

  1. 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

Secondary outcomes

  1. Measurement of PSA and testosterone levels if available

    Time frame: After at least 6 months treatment with Depo-Eligard

  2. Overall evaluation of efficacy

    Time frame: After a least 6 months treatment with Depo-Eligard

  3. Overall patient assessment of treatment benefit

    Time frame: After at least 6 months treatment with Depo-Eligard

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Acronym: OCT

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 19, 2008
Registry last updated
Jan 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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