CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 409 enrolled
Drug / intervention
Degarelix +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00928434
NCT00928434Phase 3Completed

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

Ferring Pharmaceuticals·interventional·Posted Jun 26, 2009·Updated Dec 13, 2016

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 26, 2009
Enrollment StartMay 1, 2009
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.0 years ago

Interventions

Degarelixdrug

Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

Degarelixdrug

Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Leuprolidedrug

Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)