NCT00738673

Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

An Open-Label, Multi-Centre, Uncontrolled, Exploratory Trial Investigating Degarelix One-Month Dosing Regimen as Second-Line Hormonal Treatment After PSA-Failure in GnRH Agonist Treated Patients With Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12 months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal treatment in Prostate Cancer patients who experienced PSA-Failure following gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in Testosterone levels at inclusion.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	degarelix	Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-08-20
• Last updated: 2013-01-18
• Results posted: 2013-01-18

Locations

15 sites across 1 country: Germany