Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer
NCT03344211 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-02-27
Summary
This randomized phase II trial studies how well enzalutamide with or without radium Ra 223 dichloride in treating patients with castration-resistant prostate cancer that has spread to other places in the body. Enzalutamide is an androgen receptor inhibitor that may slow down the growth of prostate cancer by blocking the action of the male hormone testosterone and other male hormones called androgens. Radiation therapy uses high energy alpha particles to kill tumor cells and shrink tumors. Enzalutamide with or without radium Ra 223 dichloride may work better in treating patients with castration-resistant prostate cancer.
Conditions
- Castration-Resistant Prostate Carcinoma
- Prostate Carcinoma Metastatic in the Bone
- Stage IV Prostate Cancer
Interventions
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- RADIATION
-
Radium Ra 223 Dichloride
Given IV
- DRUG
-
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Southern California
lead OTHER
Principal Investigators
-
David I Quinn, MD · University of Southern California
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-21
- Primary Completion
- 2026-11-21
- Completion
- 2027-11-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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