Treatment of Prostate Cancer With Firmagon®

April 9, 2020 updated by: Karin Buchsteiner, United Clinic Management GmbH

Effectiveness and Safety as Well as Adherence of the "S3 Guidelines for the Treatment of Prostate Cancer" in the Treatment of Patients of Patients With Firmagon®

How are testosterone levels of patients with prostate cancer under treatment with Firmagon® changing.

Former studies showed a quick fall of testosterone levels after start of therapy with Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this in a normal outpatient urologist setting. Furthermore data is collected to prove the adherence to the German S3-Guideline for the treatment of prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

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

  • Germany
    • Bavaria
      • Planegg, Bavaria, Germany, 82152
        • UCM GmbH

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

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

adult male patients of outpatient urological medical practice

Description

Inclusion Criteria:

  • advanced hormone-dependent prostate cancer with no other previous hormone therapy for whom - irrespectively of this NIS -the use of Firmagon® is intended

Exclusion Criteria:

  • contraindication for Degarelix

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Degarelix
adult male patients with advanced hormone dependent prostate cancer who receive 240 mg as a start dose and then monthly 80mg Firmagon® for one year
Drug: Degarelix
subcutaneous injection
Other Names:
  • Firmagon®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PSA-/Testosterone Level
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
S3 Guideline
Time Frame: 12 months
Percentage of patients who have been treated in accordance with the grade A recommendations of the S3 guideline for treatment of prostate cancer
12 months
Anxiety
Time Frame: 12 Months
Anxiety score
12 Months

Collaborators and Investigators

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

Sponsor

United Clinic Management GmbH

Investigators

  • Principal Investigator: Leopold Durner, MD, UCM GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 24, 2015

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (Estimate)

October 18, 2012

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCM12-01

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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