Treatment of Prostate Cancer With Firmagon®

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT01710098
• Lead Sponsor: United Clinic Management GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-18
• Primary Completion: 2014-06
• Study Completion: 2015-09-24
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Degarelix	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

Primary Outcome Measures

Name	Time	Method
PSA-/Testosterone Level	12 months

Secondary Outcome Measures

Name	Time	Method
Anxiety	12 Months	Anxiety score
S3 Guideline	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

Trial Locations

Locations (1)

UCM GmbH; 🇩🇪 Planegg, Bavaria, Germany