NCT00928434

A Study of Degarelix in Patients With Prostate Cancer

A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 409 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.

Detailed description

This was an open-label, randomized, parallel-arm, multicenter study to determine if degarelix intermittent therapy was non-inferior to continuous androgen deprivation therapy (combination of treatment groups receiving continuous degarelix and leuprolide therapy, respectively) in maintaining PSA levels at ≤ 4.0 ng/mL at 14 months. The study consisted of two phases, Phase A and B. During Phase A, patients in the degarelix intermittent and degarelix continuous arms received 7 months of therapy with degarelix one-month depot formulation and patients in the leuprolide continuous arm received leuprolide one-month depot injection (7.5 mg) followed by two 3-month depot (22.5 mg) injections. After 7 months of treatment, patients with a PSA ≤2 ng/mL continued into Phase B. During Phase B, patients in the degarelix intermittent arm had a 7-month off-treatment period. Patients randomized to the degarelix continuous arm and the leuprolide continuous arm continued to receive degarelix or leuprolide depot as in Phase A for the remainder of the 14 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Degarelix	Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.
DRUG	Degarelix	Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).
DRUG	Leuprolide	Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2009-06-26
• Last updated: 2016-12-13
• Results posted: 2016-12-13

Locations

59 sites across 1 country: United States