11 results
The goal of this study is to prove that there is a benefit in terms of post-operative outcome not only because of the multi-modal improvements in peri-operative fluid management through the ERAS program, but also by the use of a goal-directed fluid…
The purpose of this study is to evaluate the efficacy and safety of MDV3100, a novel potent androgen-receptor antagonist without known agonist activity, in asymptomatic or mildly symptomatic patients with progressive metastatic prostate cancer who…
1) Objective: To evaluate the safety and tolerability of the pembrolizumab combination therapy.2) Objective: To estimate PSA response rate of the pembrolizumab combination therapy. PSA response is defined as a reduction in the PSA level of 50% or…
1) To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to overall survival (OS)2) To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to radiographic progression-free survival…
The purpose of this research study is to learn about the safety and effectiveness of 177Lu-PNT2002, an investigational agent being studied for patients with mCRPC who have experienced disease progression following treatment with abiraterone,…
Primary objectiveTo demonstrate that talazoparib in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging investigator--assessed Radiographic Progression-free Survival (rPFS), in participants with mCSPC…
The objective of this study is to evaluate the effect of enzalutamide on morphine and edoxaban pharmacokinetics. This information is urgently needed to optimize the treatment of patients with prostate cancer using enzalutamide and facilitate the…
Primary Objective- To determine the benefit of enzalutamide plus ADT as compared to placebo plus ADT as assessed by radiographic progression-free survival (rPFS) based on central reviewMain Secondary Objectives- To determine the benefit of…
Primary Objective:• To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) until 24 weeks.Key Secondary Objective:• To…
To determine the effects of the CytoSorb hemoperfusion column on the development of immunoparalysis in a repeated human endotoxemia model, which is reflected by attenuated plasma cytokine levels during the second LPS challenge.
All efficacy and safety objectives will compare enzalutamide plus leuprolide and enzalutamide monotherapyversus placebo plus leuprolide.