Open Label Phase Two Study of Enzalutamide With Concurrent Administration of Radium Ra 223 Dichloride in Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Symptomatic Bone Metastasis
NCT02507570 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2019-03-19
Summary
This is an open label study designed to examine the effects of Enzalutamide with concurrent administration of Radium Ra 223 dichloride in Castrate-Resistant (Hormone-Refractory) Prostate Cancer subjects with symptomatic bone metastases in both the pre- and post-chemotherapy setting.
Conditions
- Prostate Carcinoma Metastatic to the Bone
Interventions
- DRUG
-
used concomitantly
- RADIATION
-
Radium ra 223 dichloride
Sponsors & Collaborators
-
Astellas Pharma Inc
collaborator INDUSTRY -
Carolina Research Professionals, LLC
lead OTHER
Principal Investigators
-
Neal D Shore, MD · Carolina Research Professionals, LLC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-23
- Primary Completion
- 2019-01-18
- Completion
- 2019-01-18
Countries
- United States
Study Locations
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