NCT03344211

Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer

Immune Activation and Cellular Response From Enzalutamide Alone or With Radium223 in Men With Metastatic, Castration-Resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate changes in prostate cancer bone involvement induced by enzalutamide alone or in combination with radium Ra 223 dichloride (radium 223), specifically extent of prostate cancer infiltration, androgen receptor (AR) signaling and hormone levels, hematopoietic composition, apoptosis and proliferation. II. To evaluate the immune activation of enzalutamide alone, or with radium 223. SECONDARY OBJECTIVES: I. To describe the adverse event profile for the combination in this patient population. II. Rate of undetectable prostate specific antigen (PSA) nadir, PSA and alkaline phosphatase changes, rate of symptomatic skeletal events at 12 months, and rate of PSA and radiographic progression at 12 months. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive enzalutamide orally (PO) daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive radium Ra 223 dichloride intravenously (IV) on day 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive enzalutamide as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1.5 years.

Conditions

• Castration-Resistant Prostate Carcinoma
• Prostate Carcinoma Metastatic in the Bone
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
RADIATION	Radium Ra 223 Dichloride	Given IV

Timeline

• Start date: 2018-11-21
• Primary completion: 2026-11-21
• Completion: 2027-11-21
• First posted: 2017-11-17
• Last updated: 2026-02-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study