At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Degarelix and Leuprolide for Prostate Cancer. Completed, enrolled 409 participants across 59 sites.
Detailed 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.
Study Details
Timeline
Interventions
Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.
Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).
Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)