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)

January 10, 2014 updated by: Astellas Pharma Europe B.V.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

259

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Site: 38
    • Antwerp
      • Antwerpen, Antwerp, Belgium, 2018
        • Site: 5
      • Antwerpen, Antwerp, Belgium, 2018
        • Site: 8
      • Antwerpen, Antwerp, Belgium, 2018
        • Site: 9
      • Antwerpen, Antwerp, Belgium, 2020
        • Site: 14
      • Antwerpen, Antwerp, Belgium, 2200
        • Site: 4
      • Merksem, Antwerp, Belgium, 2170
        • Site: 33
      • Turnhout, Antwerp, Belgium, 2300
        • Site: 1
    • Brussels Capital Region
      • Brussel, Brussels Capital Region, Belgium, 1090
        • Site: 13
      • Bruxelles, Brussels Capital Region, Belgium, 1030
        • Site: 23
      • Uccle, Brussels Capital Region, Belgium, 1180
        • Site: 24
    • East Flanders
      • Aalst, East Flanders, Belgium, 9300
        • Site: 32
      • Dendermonde, East Flanders, Belgium, 9200
        • Site: 34
      • Gent, East Flanders, Belgium, 9000
        • Site: 11
      • Oudenaarde, East Flanders, Belgium, 9700
        • Site: 17
    • Flemish Brabant
      • Tienen, Flemish Brabant, Belgium, 3300
        • Site: 18
    • Hainaut
      • La Louvière, Hainaut, Belgium, 7100
        • Site: 39
    • Limburg
      • Sint Truiden, Limburg, Belgium, 3800
        • Site: 37
    • Walloon Brabant
      • Lasne Chapelle Saint Lambert, Walloon Brabant, Belgium, 1380
        • Site: 26
    • West Flanders
      • Ieper, West Flanders, Belgium, 8900
        • Site: 21
      • Izegem, West Flanders, Belgium, 8870
        • Site: 20
      • Kortijk, West Flanders, Belgium, 8500
        • Site: 25
      • Oostende, West Flanders, Belgium, 8400
        • Site: 31

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Consultation at urology department

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostate Cancer patients
Drug: Depo-Eligard®
Subcutaneous
Other Names:
  • Leuprolide Acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of tolerability of treatment on a 4 point scale
Time Frame: Last Visit (after at least 180 days of treatment)
Last Visit (after at least 180 days of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Adverse Drug Reactions
Time Frame: Day 1 and Last Visit (after at least 180 days of treatment)
Day 1 and Last Visit (after at least 180 days of treatment)
Investigator satisfaction with treatment
Time Frame: Last Visit (after at least 180 days of treatment)
Last Visit (after at least 180 days of treatment)
Overall patient's assessment of treatment benefit
Time Frame: Last Visit (after at least 180 days of treatment)
Last Visit (after at least 180 days of treatment)
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)
Day 1 and Last Visit (after at least 180 days of treatment)
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)
Day 1 and Last Visit (after at least 180 days of treatment)
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
Day 1 and Last Visit (after at least 180 days of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Europe B.V.

Collaborators

Veeda Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (ESTIMATE)

February 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE-11-EGD-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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