A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to investigate radiographic progression-free survival (PFS) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease.

Official Title
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A Phase 2, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Conditions
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Metastatic Castration-Resistant Prostate Cancer

Intervention / Treatment
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* Drug: Enzalutamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Progressive prostate cancer while on androgen deprivation therapy Castrate testosterone level Maintenance of surgical or medical castration for duration of study Radiographically visible metastatic disease Symptomatic from prostate cancer Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy >=6 months Exclusion Criteria: Brain metastases or leptomeningeal disease Prior cytotoxic chemotherapy for prostate cancer Prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor History of seizure or condition that may predispose to seizure History of loss of consciousness or transient ischemic attack within 12 months Clinically significant cardiovascular disease
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enzalutamide<br> | Drug: Enzalutamide<br>* oral<br>* Other names: MDV3100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic progression free survival (PFS) | Time from first dose on Day 1 to the first objective evidence of radiographic progression or death due to any cause (whichever occurs first). Radiographic disease progression is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Clinical Trials Working Group 2 (PCWG2). | 26 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from first dose on Day 1 to death due to any cause | 26 months | 
| Time to PSA progression | Time from first dose on Day 1 to first observation of PSA progression | 26 months | 
| Change from baseline to last post baseline measurement Quality of life score using Functional Assessment of Cancer Therapy-Prostate (FACT-P) | The FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer patients | Baseline and 26 months | 
| Change from baseline to last post baseline measurement Quality of Life score using European Quality of Life 5-Domain Scale (EQ-5D) | EQ-5D is a standardized instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status and is designed for self-completion by respondents | Baseline and 26 months | 
| Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form) | Brief Pain Inventory is a validated instrument that is a subject self-rating scale assessing level of pain, effect of the pain on activities of daily living, and analgesic use | Baseline and 26 months | 
| Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs) |  | 26 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, MDV3100, prostate, enzalutamide