Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01949337|
Recruitment Status : Active, not recruiting
First Posted : September 24, 2013
Last Update Posted : April 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer||Drug: enzalutamide Drug: abiraterone Drug: prednisone||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1311 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2019|
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, orally
abiraterone 1000 mg daily, orally
prednisone 5 mg twice daily, orally
- Overall survival (OS) [ Time Frame: Up to 5 years post treatment ]
- 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 ]
- Decline in Prostate Specific Antigen (PSA) [ Time Frame: Up to 5 years post treatment ]
- Progression Free Survival (PFS) [ Time Frame: Up to 5 years post treatment ]
- Objective response rate [ Time Frame: Up to 5 years post treatment ]
- Radiographic Progression Free Survival (rPFS) [ Time Frame: Up to 5 years post treatment ]
- Tumor burden and bone activity [ Time Frame: Up to 5 years post treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949337
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|Study Chair:||Michael Morris, M.D.||Memorial Sloan Kettering Cancer Center|