CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 127 enrolled
Drug / intervention
Degarelixdrug
Likely dose
Degarelix maintenance dose given in twelve 28-day cycles (specific dose not stated)AI-extracted
Key inclusion· 5
  • ✓Histologically confirmed adenocarcinoma of the prostate (all stages) requiring endocrine treatment, including rising PSA after radical prostatectomy or radiotherapy with curative intent.
  • ✓Baseline testosterone above the lower limit of normal range.
  • ✓ECOG performance status 0-2.
  • ✓PSA value ≥2 ng/mL.
Key exclusion· 8
  • ✕Prior or ongoing hormonal therapy for prostate cancer (surgical castration, GnRH agonists, GnRH antagonists, antiandrogens, estrogens). Exception: neoadjuvant hormonal therapy ≤6 months duration completed ≥6 months before screening is allowed.
  • ✕Treatment with any drug modifying testosterone level or function within 12 weeks before screening.
  • ✕Candidate for curative therapy (radical prostatectomy or radiotherapy) within 6 months from screening.
  • ✕History of severe asthma (requiring daily oral or inhalation steroids), anaphylactic reactions, angioedema, or angioneurotic edema.

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

Search/NCT00116779
NCT00116779Phase 2Completed
CompareCT.gov

An Open-label, Randomized, Multi-center, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer Dosed for Thirteen 28-day Cycles

Ferring Pharmaceuticals·interventional·Posted Jul 1, 2005·Updated Dec 19, 2011

In Brief

A Phase 2 clinical trial evaluating Degarelix for Prostate Cancer. Completed, enrolled 127 participants across 35 sites in 2 countries.

Detailed Summary

The purpose of the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment of prostate cancer by a rapid and sustained suppression of testosterone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 1, 2005
Enrollment StartFeb 1, 2004
Primary CompletionAug 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 21.0 years ago

Interventions

Degarelixdrug

Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.