PURPOSE: The efficacy of @entity3102 plus the immunostimulatory cytokine @entity2841 was prospectively evaluated in @entity1 with castration resistant @entity263 with and without @entity3 . MATERIALS AND METHODS: Eligible @entity1 had progressive castration resistant @entity263 by consensus criteria and had received no prior immunotherapy, chemotherapy or @entity3102 . @entity1 received 400 mg @entity3102 orally 3 times daily, and 20 mg @entity701 orally each morning and 10 mg @entity701 orally each evening. @entity2841 ) was administered subcutaneously on days 15 to 28 of each 28-day cycle. Progression was defined as disease progression or @entity137 . RESULTS: A total of 49 @entity1 were enrolled, including 37 with radiographically evident @entity3 and 12 with @entity1486 only disease. Median @entity1 age was 68 years (range 52 to 84) and median @entity1486 was 23.1 ng/ml (range 5.4 to 306.5). Time to progression, which was the primary study end point, was 9.7 months for all @entity1 . Ten of the 30 treatment failures showed radiographic progression and 6 were due to @entity137 , while treatment failure in 14 of 30 @entity1 (47%) consisted only of increasing @entity1486 . Median time to progression was 6.9 and 15.4 months in @entity1 with and without @entity3 , respectively (p = 0.01). Of 48 @entity1 36 (75%, 95% CI 60-86) experienced a 50% or greater decrease in @entity1486 . Four grade 4 events occurred that were unrelated to the study drug. Grade 3 events related to study therapy in more than 1 @entity1 consisted of fatigue in 7 (14%). CONCLUSIONS: Combined @entity3102 and @entity2841 yields a high response rate and it is an option for @entity1 with castration resistant @entity263 . Time to progression in @entity1 without @entity3 is significantly longer than in those without @entity3 .

Phase II study of @entity3102 plus @entity2841 for XXXX : effect of extent of disease on outcome.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity263 :: ('MESH:D011471', 'Disease') :: ['prostate cancer'] @entity3102 :: ('MESH:D007654', 'Chemical') :: ['ketoconazole'] @entity701 :: ('MESH:D006854', 'Chemical') :: ['hydrocortisone'] @entity3 :: ('MESH:D009362', 'Disease') :: ['metastases'] @entity2841 :: ('1437', 'Gene') :: ['Granulocyte-macrophage colony-stimulating factor (250 microg/m2', 'granulocyte-macrophage colony-stimulating factor'] @entity1486 :: ('354', 'Gene') :: ['prostate specific antigen']
@entity263 :: (MESH:D011471,Disease) :: ['prostate cancer']
