New combo aims to outsmart drug-resistant prostate cancer
NCT ID NCT02452008
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a new drug (LY2157299) to the standard treatment enzalutamide can help men with advanced prostate cancer that has stopped responding to other treatments. About 60 participants will be randomly assigned to receive either the combination or enzalutamide alone. The goal is to see if the combination can delay cancer growth and improve survival.
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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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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2016
- Expected to finish
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Dec 2026
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 to 100 years
- 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: * Have metastatic castration-resistant prostate cancer * Must have had prior abiraterone treatment * Life expectancy of greater than 3 months * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2 * Age ≥18 years * Have measurable disease * Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator). * Ability to take oral medication * Patients must have adequate organ and marrow function defined by study-specified laboratory tests * Must use acceptable form of birth control while on study * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * Known history or evidence of brain metastases * Prior chemotherapy for metastatic disease in castration-resistant prostate cancer * Had surgery within 4 weeks prior to the first dose of study drug * Had radiation, biological, or other investigational cancer therapy within 2 weeks prior to the first dose of study drug * Had second-line hormonal therapy within 2 weeks prior to the first dose of study drug * Systemic steroids within 1 weeks prior to the first dose of study drug * Had prior enzalutamide, ARN-509, or galeterone therapy * Have moderate or severe cardiovascular disease * Have a history of a seizure * Have uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements * Have a history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythmatosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), central nervous system (CNS) or motor neuropathy considered to be of autoimmune origin (e.g., Guillian-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis) * Have known history of infection with HIV, hepatitis B, or hepatitis C
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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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Johns Hopkins University
Baltimore, Maryland, 21205, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
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University of Chicago
Chicago, Illinois, 60637, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?