25 results
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. To assess the effects of 3 months neoadjuvant androgen ablation with enzalutamide on the surgicial margin status of men with non-metastasized prostate cancer.2. To properly evaluate the effects of androgen ablation on gene expression, analyses of…
To compare treatment with enzaluatmide plus BI836845 with treatment with enzalutamide only.
To investigate the influence of concomitant enzalutamide on the pharmacokinetics of cabazitaxel.
The primary objective of this research is to compare the efficacy of continuing treatment with enzalutamide after adding docetaxel and prednisolone versus placebo plus docetaxel and prednisolone, as measured by progression-free survival (PFS) in…
The aim of this phase IVI, randomized, open-label study is to compare the efficacy of cabazitaxel versus an AR targeted agent, in patients previously treated with docetaxel and likely to have primary resistance to AR targeted agents.
1. To evaluate the feasibility of 18F-FDG PET/CT, or WB MRI or both to determine metastatic tumour load before and after treatment with Enzalutamide in CRPC patients. 2. To evaluate how these 2 imaging modalities perform compared to traditional…
Primary Objectives:To explore whether the decrease in a panel of early easily assessable biomarkers (PSA-mRNA, PCA3-mRNA and TMPRSS2:ERG gene fusion-mRNA, (currently under development) ARv7 mRNA, ARwt mRNA, miR-21, miR-141, miR-200a, miRrumc95,…
To determine the efficacy (as assessed by rPFS) and safety of olaparib versus investigator choice of enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal…
The primary objective is to establish the non-inferiority of treating a symptomatic urinary tract infection in patients with a long-term indwelling catheter for 5 days, as compared to the standard duration of 10 days of therapy. Secondary objectives…
Primary • To determine the efficacy of enzalutamide compared with placebo as assessed by metastasis-free survival (MFS). Secondary: • To evaluate the benefit of enzalutamide compared with placebo as measured by the following:- Time to PSA…
1. To compare pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT with respect to radiographic progression free survival (rPFS)2. To compare pembrolizumab plus enzalutamide plus ADT versus placebp plus enzalutamide…
1. To evaluate the feasibility of 18F-FDG PET/CT, or WB MRI or both to determine metastatic tumour load before and after treatmentwith Enzalutamide in patients with metastatic prostate cancer.2. To evaluate how these 2 imaging modalities perform…
The purpose of this study is to determine whether 177Lu-PSMA-617, given for 6 cycles at a dose of 7.4 Gigabecquerel (GBq) (200 Millicuries (mCi)) +/- 10%, improves the radiographic progression free survival (rPFS) or death compared to a change in…
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…
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…
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…
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…
The objective of the study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide (as assessed by the investigator) from their participation in an enzalutamide clinical study…