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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

NCT01793077 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 259

Last updated 2014-01-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Depo-Eligard®

Subcutaneous

Sponsors & Collaborators

  • Veeda Clinical Research

    collaborator INDUSTRY

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Europe B.V.

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01793077 on ClinicalTrials.gov