New combo therapy targets bone metastases in prostate cancer
NCT ID NCT03344211
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial studies whether adding radium-223 to enzalutamide works better than enzalutamide alone in men with castration-resistant prostate cancer that has spread to bones. Enzalutamide blocks male hormones that fuel cancer growth, while radium-223 delivers targeted radiation to bone tumors. The study involves 30 participants and will measure changes in bone involvement through biopsies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- enzalutamide and radium-223
- What this could lead to
- If successful, this could point toward a more effective combination treatment for men with advanced prostate cancer that has spread to the bones.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to all patients. The study is also no longer recruiting, and it is unclear if the combination will improve outcomes over enzalutamide alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Nov 2018
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
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City of Hope
Duarte, California, 91010, United States
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
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Other studies related to the condition(s) this trial covers.
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