35 results
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 objectives- To determine the decrease in the CNS side effect fatigue* in frail (m)CRPC patients treated with a reduced dose of enzalutamide (120mg OD) compared to the standard dose of enzalutamide (160mg OD) after 6 weeks of…
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…
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…
To evaluate the safety and efficacy of DOAC versus VKA in CTEPH/CTED patients receiving BPA, based on the composite endpoint of periprocedural bleeding (life-threatening or disabling bleeding, vascular injury or access site problems) and lung injury…
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 investigate the safety and tolerability of CCS1477 as monotherapy and in combination.
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,…
1) To compare pembrolizumab plus olaparib to abiraterone acetate or enzalutamide with respect to overall survival (OS)2) To compare pembrolizumab plus olaparib to abiraterone acetate or enzalutamide with respect to radiographic progression-free…
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…
The primary objective is to evaluate whether the impact of a strategy aimed at switching INR-guided VKA management to a NOAC-based treatment strategy is superior in terms of the occurrence of major or clinically relevant non-major bleeding…
To measure DOAC levels just before surgery of all DOAC patients in the LUMC with elective surgery for which ceasing of DOAC treatment is required.
All efficacy and safety objectives will compare enzalutamide plus leuprolide and enzalutamide monotherapyversus placebo plus leuprolide.
Primary: * To assess Clinical Benefit Rate (CBR) in patients with mCRPC and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy.Secondary: * To formally compare CBR in both…