At a glance
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A Randomized Phase II Study of Androgen Deprivation Combined With IMC-A12 Versus Androgen Deprivation Alone for Patients With New Hormone Sensitive Metastatic Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Bicalutamide, Cixutumumab, and 4 other interventions for Prostate Adenocarcinoma and 2 related conditions. Completed, enrolled 211 participants across 170 sites in 2 countries.
Detailed Summary
This randomized phase II trial is studying bicalutamide, goserelin, or leuprolide acetate to see how well they work when given with or without cixutumumab in treating patients with newly diagnosed metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, goserelin, or leuprolide acetate, may lessen the amount of androgens made by the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether bicalutamide, goserelin, or leuprolide acetate are more effective when given with or without cixutumumab in treating prostate cancer.
Study Details
Timeline
Interventions
Given PO
Given IV
Given SC
Correlative studies
Given IM
Correlative studies