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

No results posted yet for this study

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

Enzalutamide

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344211 on ClinicalTrials.gov