Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer
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.
Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer|
- Overall survival (OS) [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: No ]
- Grade 3 or higher toxicity profile using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: Yes ]
- Decline in Prostate Specific Antigen (PSA) [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: Yes ]
- Progression Free Survival (PFS) [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: No ]
- Objective response rate [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: No ]
- Radiographic Progression Free Survival (rPFS) [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: No ]
- Tumor burden and bone activity [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2014|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
Experimental: Arm A: (enzalutamide)
Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
Enzalutamide 160 mg daily, orally
Experimental: Arm B: (enzalutamide, abiraterone, prednisone)
Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
Enzalutamide 160 mg daily, orallyDrug: abiraterone
abiraterone 1000 mg daily, orallyDrug: prednisone
prednisone 5 mg twice daily, orally
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.
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01949337
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|Study Chair:||Michael Morris, M.D.||Memorial Sloan Kettering Cancer Center.|