NCT00801242

Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.

Detailed description

The participants received one or more treatment cycles of seven monthly degarelix doses during the induction period(s). The off-treatment period(s) started when prostate-specific antigen (PSA) ≤4 ng/mL and lasted up to 24 months based on PSA levels. A visit was scheduled on a monthly basis during the induction treatment periods, and every two months during the off-treatment periods. During the off-treatment periods, degarelix treatment was re-initiated when PSA \>4 ng/mL. The maximum of degarelix IAD treatment cycles that a participant could receive was limited to three.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Degarelix 240 mg / 80 mg	For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-06-01
• Completion: 2013-07-01
• First posted: 2008-12-03
• Last updated: 2014-09-03
• Results posted: 2014-09-03

Locations

52 sites across 6 countries: Belgium, France, Germany, Italy, Netherlands, Spain