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Castration-Resistant Prostate CarcinomaPhase 2NCT03344211

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

A Phase 2 study testing Enzalutamide, Laboratory Biomarker Analysis and Radium Ra 223 Dichloride in people with Castration-Resistant Prostate Carcinoma and Prostate Carcinoma Metastatic in the Bone, run by University of Southern California at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Enzalutamide, Laboratory Biomarker Analysis and Radium Ra 223 Dichloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesUnited States
Study dates
21 Nov 2018to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)
  • Ability to understand and the willingness to sign a written informed consent

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • City of Hope

    Duarte, California, 91010

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Enzalutamide, Laboratory Biomarker Analysis, Radium Ra 223 Dichloride
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnzalutamideDrug

    Also called ASP9785, MDV3100, Xtandi

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Radium Ra 223 DichlorideRadiation

    Also called Alpharadin, BAY 88-8223, BAY88-8223, Radium 223 Dichloride

    Given IV

Study groups in NCT03344211
Study groupRoleWhat they receive
Arm I (enzalutamide, radium 223)ExperimentalPatients 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.
Receives: Drug: Enzalutamide; Other: Laboratory Biomarker Analysis; Radiation: Radium Ra 223 Dichloride
Arm II (enzalutamide)ExperimentalPatients receive enzalutamide as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Enzalutamide; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in prostate cancer bone involvement

    Will be determined by standard pathologic analysis of the biopsies.

    Measured: Up to 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start21 Nov 2018
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03344211
Sponsor's protocol ID
4P-16-2
Other IDs
NCI-2017-01418, 4P-16-2, P30CA014089
Status last verified
May 2026
First submitted
4 Nov 2017
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enzalutamide, Laboratory Biomarker Analysis and Radium Ra 223 Dichloride in people with Castration-Resistant Prostate Carcinoma and Prostate Carcinoma Metastatic in the Bone, run by University of Southern California at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in prostate cancer bone involvement (time frame: Up to 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03344211.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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