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Androgen Receptor Inhibitor

Enzalutamide +/- Radium Ra 223 for Prostate Cancer

Phase 2

Waitlist Available

Led By David I Quinn, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men with metastatic, castration resistant prostate cancer involving the bone, which is symptomatic or asymptomatic

Radiographic progression, with at least 1 new site of metastasis

Must not have

Known untreated central nervous system (CNS) metastases; leptomeningeal disease will be an absolute exclusion criterion due to limited life expectancy

Known hepatitis (hep) B or C, or known cirrhosis (screening for viral hepatitis is not required)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1.5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial studies how well enzalutamide with or without radium Ra 223 dichloride works in treating patients with castration-resistant prostate cancer.

Who is the study for?

This trial is for men with metastatic, castration-resistant prostate cancer that has spread to the bone. Participants must have a hemoglobin level of at least 9.5 g/dL, rising PSA levels, and be in good physical condition (ECOG status 0-1). They should not have had certain prior treatments like docetaxel or cabazitaxel for metastatic cancer and no recent seizures or significant cardiovascular events.

What is being tested?

The study is testing whether enzalutamide alone or combined with radium Ra 223 dichloride is more effective in treating prostate cancer that resists standard hormone therapy. Enzalutamide blocks male hormones to slow cancer growth; radium Ra 223 delivers radiation directly to tumors.

What are the potential side effects?

Enzalutamide may cause fatigue, back pain, constipation, joint pain, and hot flushes. Radium Ra 223 can lead to nausea, diarrhea, vomiting and blood-related side effects such as anemia or low platelet counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have prostate cancer that has spread to my bones, with or without symptoms.

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My cancer has spread to a new area.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have untreated brain metastases or leptomeningeal disease.

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I have hepatitis B, C, or cirrhosis.

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I do not have any severe illnesses that would stop me from following the study's requirements.

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I have been treated with specific radioactive drugs for bone cancer spread.

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I have had treatment for spinal cord compression.

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I haven't had seizures, TIAs, or strokes in the last 6 months.

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I have been treated with docetaxel or cabazitaxel for prostate cancer.

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I have chronic diarrhea or have been diagnosed with Crohn's or ulcerative colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in prostate cancer bone involvement

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (enzalutamide)Experimental Treatment2 Interventions

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

Group II: Arm I (enzalutamide, radium 223)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

FDA approved

Radium Ra 223 Dichloride

2017

Completed Phase 2

~90

0 / 11Eligibility criteria met