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

NCT03344211 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 4P-16-2NCI-2017-01418P30CA014089
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Changes in prostate cancer bone involvement

  Will be determined by standard pathologic analysis of the biopsies.

  Up to 1.5 years

Study Arms (2)

Arm I (enzalutamide, radium 223)

EXPERIMENTAL

Patients receive enzalutamide 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 IV on day 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: Enzalutamide; Other: Laboratory Biomarker Analysis; Radiation: Radium Ra 223 Dichloride

Arm II (enzalutamide)

EXPERIMENTAL

Patients receive enzalutamide as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Enzalutamide; Other: Laboratory Biomarker Analysis

Interventions

Enzalutamide DRUG

Given PO

Also known as: ASP9785, MDV3100, Xtandi

Arm I (enzalutamide, radium 223); Arm II (enzalutamide)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (enzalutamide, radium 223); Arm II (enzalutamide)

Radium Ra 223 Dichloride RADIATION

Given IV

Also known as: Alpharadin, BAY 88-8223, BAY88-8223, Radium 223 Dichloride, RADIUM CHLORIDE RA-223, Radium-223 Dichloride, Xofigo

Arm I (enzalutamide, radium 223)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with metastatic, castration resistant prostate cancer involving the bone, which is symptomatic or asymptomatic
• Castration resistance will be defined as the development of disease progression, defined as one of the following:
• Rising PSA x 2 values \>= 2 weeks apart; minimum absolute PSA value 2 ng/mL
• Radiographic progression, with at least 1 new site of metastasis
• Symptomatic progression (ex: increase in pain despite stable imaging) AND despite ongoing luteinizing hormone-releasing hormone (LHRH) therapy OR testosterone level \< 50
• Men must have osseous metastases, but the presence of visceral metastases will not exclude patients from participation
• Prior external beam radiation therapy (\> 4 weeks prior to enrollment) for palliation of osseous metastatic disease is allowed, provided there is at least one osseous metastasis which has not been irradiated and which can be biopsied
• No prior docetaxel or cabazitaxel chemotherapy for metastatic castration-resistant prostate cancer (mCRPC) (men treated with prior docetaxel administered as up-front therapy with androgen deprivation therapy \[ADT\] \> 6 months ago will be eligible); prior abiraterone is allowed
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Hemoglobin \>= 9.5 g/dL
• Absolute neutrophil count \>= 1,500
• Platelets \>= 100,000
• Total bilirubin within normal institutional limits
• Creatinine clearance (calculated or measured) \> 30 mL/min
• At least one risk factor predicting higher likelihood of bone marrow sample yield: elevated alkaline phosphatase, low hemoglobin, or elevated lactate dehydrogenase (LDH)

You may not qualify if:

• Prior treatment with docetaxel or cabazitaxel for mCRPC
• Prior treatment with ARN-509 or enzalutamide (there is a grace period for men who wish to enroll and who have recently started enzalutamide for the first time but have taken less than 15 days of therapy)
• Concurrent use of androgen deprivation therapy aside from LHRH agonist or antagonist (i.e. bicalutamide, flutamide, nilutamide, abiraterone, ketoconazole, estrogen); there will be a 2 week wash-out period from the last dose of any of these agents until the first dose of enzalutamide on study; patients who have just started enzalutamide for fewer than 5 doses prior to enrollment in the trial are still considered eligible and not subject to wash-out
• Concurrent oral corticosteroid use aside from adrenal replacement, or use of other immunosuppressive agents (ex: infliximab); topical or inhaled steroids will be allowed
• Received systemic therapy with radionuclides (e.g., strontium-89, samarium- 153, rhenium-186, or rhenium-188, or radium Ra 223 dichloride) for the treatment of bony metastases
• History of seizures except for remote with specific etiology which has resolved (ex: alcohol induced seizure); transient ischemic attack (TIA) or cerebrovascular accident (CVA) within last 6 months
• Chronic diarrhea \> grade 1, or a diagnosis of Crohn?s or ulcerative colitis
• Known hepatitis (hep) B or C, or known cirrhosis (screening for viral hepatitis is not required)
• Uncontrolled intercurrent illness such as infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness which would limit compliance with study requirements
• Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); treatment should be completed for spinal cord compression

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Southern California: lead

Study Sites (3)

City of Hope

Duarte, California, 91010, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide; radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• David I Quinn, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2017
• First Posted: November 17, 2017
• Study Start: November 21, 2018
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): November 21, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (3)