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

Phase 2

Withdrawn

• Conditions: Metastatic Castration-Resistant Prostate Cancer
• Interventions: Drug: Enzalutamide

• Registration Number: NCT01663415
• Lead Sponsor: Astellas Pharma Global Development, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-09
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-13
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-14
• Last Update Posted: 2012-09-17
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enzalutamide	Enzalutamide	-

Primary Outcome Measures

Name	Time	Method
Radiographic progression free survival (PFS)	26 months	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).

Secondary Outcome Measures

Name	Time	Method
Overall survival	26 months	Time from first dose on Day 1 to death due to any cause
Time to PSA progression	26 months	Time from first dose on Day 1 to first observation of PSA progression
Change from baseline to last post baseline measurement Quality of life score using Functional Assessment of Cancer Therapy-Prostate (FACT-P)	Baseline and 26 months	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
Change from baseline to last post baseline measurement Quality of Life score using European Quality of Life 5-Domain Scale (EQ-5D)	Baseline and 26 months	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
Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form)	Baseline and 26 months	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
Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs)	26 months