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

NCT ID: NCT01793077

Last Updated: 2014-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

259 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Prostate Cancer patients

Depo-Eligard®

Intervention Type DRUG

Subcutaneous

Interventions

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Depo-Eligard®

Subcutaneous

Intervention Type DRUG

Other Intervention Names

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Leuprolide Acetate

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Veeda Clinical Research

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

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Site: 5

Antwerp, Antwerp, Belgium

Site Status

Site: 8

Antwerp, Antwerp, Belgium

Site Status

Site: 9

Antwerp, Antwerp, Belgium

Site Status

Site: 14

Antwerp, Antwerp, Belgium

Site Status

Site: 4

Antwerp, Antwerp, Belgium

Site Status

Site: 33

Merksem, Antwerp, Belgium

Site Status

Site: 1

Turnhout, Antwerp, Belgium

Site Status

Site: 23

Brussels, Brussels Capital, Belgium

Site Status

Site: 13

Brussels, Brussels Capital, Belgium

Site Status

Site: 24

Uccle, Brussels Capital, Belgium

Site Status

Site: 32

Aalst, East Flanders, Belgium

Site Status

Site: 34

Dendermonde, East Flanders, Belgium

Site Status

Site: 11

Ghent, East Flanders, Belgium

Site Status

Site: 17

Oudenaarde, East Flanders, Belgium

Site Status

Site: 18

Tienen, Flemish Brabant, Belgium

Site Status

Site: 39

La Louvière, Hainaut, Belgium

Site Status

Site: 37

Sint-Truiden, Limburg, Belgium

Site Status

Site: 38

Liège, Liège, Belgium

Site Status

Site: 26

Lasne-Chapelle-Saint-Lambert, Walloon Brabant, Belgium

Site Status

Site: 21

Ieper, West Flanders, Belgium

Site Status

Site: 20

Izegem, West Flanders, Belgium

Site Status

Site: 25

Kortijk, West Flanders, Belgium

Site Status

Site: 31

Ostend, West Flanders, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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BE-11-EGD-04

Identifier Type: -

Identifier Source: org_study_id

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