At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 7 enrolled
Drug / intervention
Enzalutamide +2 moredrug
Likely dose
Enzalutamide 160mgfrom 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.
Phase 2 Study of Enzalutamide and GnRH Agonist Before, During and After Radiation Therapy in Treatment of Patients With High-risk Localized Prostate Cancer
University of Texas Southwestern Medical Center·interventional·Posted Feb 17, 2014·Updated Oct 12, 2020
In Brief
A Phase 2 clinical trial evaluating Enzalutamide, Leuprolide acetate, and 1 other intervention for Prostate Cancer. Completed, enrolled 7 participants across 1 site.
Detailed Summary
The study is being done to find out whether combining two FDA approved drugs along with radiation therapy for the treatment of high risk localized prostate cancer is safe and well tolerated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsAstellas Pharma US, Inc.
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMay 2014
Primary CompletionJun 2018
TodayJul 2026
First PostedFeb 17, 2014
Enrollment StartMay 1, 2014
Primary CompletionJun 9, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 12.4 years ago
Interventions
Enzalutamidedrug
160mg by mouth each day
Leuprolide acetatedrug
22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months
radiationradiation
External beam radiation will be delivered as per standard radiation therapy protocol