NCT01949337

Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer

Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,311 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

Detailed description

Patients are randomized to one of two treatment groups: enzalutamide or enzalutamide, abiraterone and prednisone. Treatment will continue until disease progression or unacceptable toxicity. Patients are followed for clinical outcomes for a maximum of 5 years post study treatment. The primary and secondary objectives are described below. 1. Primary Objective: To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer (CRPC) treated with either enzalutamide only or enzalutamide with abiraterone and prednisone 2. Secondary Objectives: * To assess the grade 3 or higher toxicity profile and compare safety by treatment arm. * To assess and compare post-treatment prostate-specific antigen (PSA) declines by treatment arm. * To compare radiographic progression free survival defined by Prostate Cancer Working Group 2 (PCWG2), and objective response rate, by treatment arm. * To test for radiographic progression free survival (rPFS) treatment interaction in predicting overall survival. * To assess pre- and post-treatment measures of tumor burden and bone activity using sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT) and technetium (Tc) methylene diphosphonate (MDP) bone scintigraphy and correlate these measures with overall survival. * To develop and validate prognostic and predictive models of overall survival that include baseline clinical and molecular markers.

Conditions

• Adenocarcinoma of the Prostate
• Hormone-resistant Prostate Cancer
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	enzalutamide	Enzalutamide 160 mg daily, orally
DRUG	abiraterone	abiraterone 1000 mg daily, orally
DRUG	prednisone	prednisone 5 mg twice daily, orally

Timeline

• Start date: 2014-01-22
• Primary completion: 2018-11-02
• Completion: 2024-08-31
• First posted: 2013-09-24
• Last updated: 2023-09-28
• Results posted: 2020-06-01

Locations

539 sites across 3 countries: United States, Canada, Puerto Rico