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Completed

NCT Number: NCT01793077

Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients

Tremodi is an observational, non-interventional, prospective, open-label, non-comparative study that will collect real life data of a treatment with Depo-Eligard® in 3 different administrations in male prostate cancer patients.

Once the examining physician has decided on the therapeutic approach and if the selection criteria are fulfilled, he will propose the patient to participate in the study. An informed consent form will be collected for all participants in the study.

There are 2 possible study visits that coincide with a routine consultation, namely visit 1 (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment benefit of the patient.

Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both visits, if available.

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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

Sex eligibility

Male

Study type

Observational

Primary location

Site: 14, Antwerp, Belgium

Loading trial locations.

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® 7.5 mg - 22.5 mg - 45 mg in accordance with the terms of the marketing authorization.

Treatment and study plan

Depo-Eligard®

Drug

Subcutaneous

Other names: Leuprolide Acetate

Primary outcomes

  1. Evaluation of tolerability of treatment on a 4 point scale

    Time frame: Last Visit (after at least 180 days of treatment)

Secondary outcomes

  1. Occurrence of Adverse Drug Reactions

    Time frame: Day 1 and Last Visit (after at least 180 days of treatment)

  2. Investigator satisfaction with treatment

    Time frame: Last Visit (after at least 180 days of treatment)

  3. Overall patient's assessment of treatment benefit

    Time frame: Last Visit (after at least 180 days of treatment)

  4. Changes in quality of life of subjects as measured by EORTC QLQ-C30

    Time frame: Day 1 and Last Visit (after at least 180 days of treatment)

    European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-C 30 (EORTC-QLQ-C30)

  5. Frequency of use of dosing schedules of Depo-Eligard® and the reasons for selecting a schedule

    Time frame: Day 1 and Last Visit (after at least 180 days of treatment)

  6. Efficacy of treatment

    Time frame: Day 1 and Last Visit (after at least 180 days of treatment)

    (1) Changes in PSA and testosterone levels if available, (2) Change in disease symptoms and (3) Objective disease response

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Collaborators

  • Veeda Clinical Research

Registry information

Official study title

Phase IV, Non-interventional, Prospective, Open Label, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients

Acronym: TREMODI

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2013
Registry last updated
Jan 13, 2014

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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