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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
Castration resistance will be defined as the development of disease progression, defined as one of the following:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1.5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 prostate cancer has worsened despite low testosterone levels.
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I haven't had docetaxel or cabazitaxel for my advanced prostate cancer, but I may have had abiraterone.
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I am a man with bone metastases, but may also have cancer spread to organs.
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My cancer has spread to a new area.
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I had radiation therapy over 4 weeks ago for bone metastasis but have at least one bone metastasis that wasn't treated.
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My cancer symptoms are worsening despite hormone therapy or my testosterone is low.
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I am fully active or can carry out light work.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in prostate cancer bone involvement

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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,616 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,154 Patients Enrolled for Prostate Cancer
University of Southern CaliforniaLead Sponsor
899 Previous Clinical Trials
1,595,273 Total Patients Enrolled
18 Trials studying Prostate Cancer
9,422 Patients Enrolled for Prostate Cancer
David I Quinn, MDPrincipal InvestigatorUniversity of Southern California
3 Previous Clinical Trials
192 Total Patients Enrolled

Media Library

Enzalutamide (Androgen Receptor Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03344211 — Phase 2
Prostate Cancer Research Study Groups: Arm I (enzalutamide, radium 223), Arm II (enzalutamide)
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT03344211 — Phase 2
Enzalutamide (Androgen Receptor Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03344211 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Enzalutamide received the requisite FDA clearance?

"Enzalutamide's safety has been established to a degree, thus it earns a rating of 2. This is because the clinical trial status for this drug is Phase 2 and there are no results indicating its efficacy yet."

Answered by AI

What is the total number of individuals being recruited for this investigation?

"Unfortunately, this clinical trial has already filled its quota of participants and is no longer accepting new ones. The study was posted on November 21st 2018 and the last update occurred August 6th 2022. If you are curious about other trials, there are presently 3654 studies actively recruiting patients with prostate cancer as well as 98 Enzalutamide-related investigations currently enrolling individuals."

Answered by AI

Is this medical study currently recruiting participants?

"Currently, there is no recruitment for this specific medical trial. First posted on November 21st 2018 and last updated August 6th 2022; if you are seeking other trials, 3654 studies regarding prostate cancer are actively recruiting patients and 98 involving Enzalutamide require volunteers."

Answered by AI

Are there any precedents of employing Enzalutamide in clinical research?

"Currently, 98 Enzalutamide studies are live and 30 of them are in Phase 3. Germantown, Tennessee is one hub for these trials but a total of 5740 locations across the world offer clinical trial opportunities with this drug."

Answered by AI
~3 spots leftby Nov 2024