Study of Apalutamide and Abiraterone Acetate in Castration-Resistant Bone Metastatic Prostate Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03360721|
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : June 4, 2019
The goal of this clinical research study is to learn if apalutamide in combination with abiraterone acetate and prednisone can help to control metastatic (has spread) castration-resistant prostate cancer (mCRPC) that has a certain type of biomarker in the tumor. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug(s).
This is an investigational study. Apalutamide is not FDA approved or commercially available. It is currently being used for research purposes. The combination of abiraterone acetate and prednisone is FDA approved and commercially available for the treatment of mCRPC.
The study doctor can explain how the study drugs are designed to work.
Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Castration-resistant Prostate Cancer Metastatic Castration Resistant Prostate Cancer||Drug: Abiraterone Acetate 250 MG Oral Tablet [Zytiga] Drug: Apalutamide Drug: Prednisone||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Study of Apalutamide and Abiraterone Acetate in Castration-Resistant Bone Metastatic Prostate Cancer Patients Evaluating a Predetermined Biomarker Signature|
|Actual Study Start Date :||March 6, 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
Experimental: Abiraterone Acetate + Apalutamide
Abiraterone acetate 1,000 mg (4 x 250 mg tablets each) orally, Apalutamide 240 mg (4 x 60 mg tablets) orally and Prednisone 5 mg orally, all daily for four week course.
Drug: Abiraterone Acetate 250 MG Oral Tablet [Zytiga]
1,000 mg (4 x 250 mg tablets each) orally each day on empty stomach. Treatment with Abiraterone continues through duration of participation.
Other Name: Zytiga
240 mg (4 x 60 mg tablets) orally each day with or without food. Apalutamide should be taken as close to the same time each day as possible.
Other Name: ARN-509
5-mg oral, once daily (recommended to be taken with food). Treatment with prednisone will continue throughout the duration of participation.
- Progression free survival (PFS) [ Time Frame: Up to 3 years ]PFS is defined as the time from enrollment until radiographic progression (event), death from any cause (event), start of other therapy (censor) or last follow-up without progression (censor), whichever comes first.
- Summary of Most Common Adverse Events [ Time Frame: Up to 3 years ]Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03 with grade and attribution to study drug
- Composite progression free survival (PFSc) [ Time Frame: Up to 3 years ]Composite progression free survival (PFSc) is defined as the time from protocol treatment start until PCWG2 progression (radiographic progression, PSA Progression, or clinical deterioration - event), death (event), starting new treatment (censor) or last follow-up without PCWG2 progression (censor), whichever comes first.
- Overall Survival (OS) [ Time Frame: Up to 3 years ]Overall Survival is the time from protocol treatment start until death (event) or last contact (censor)
- Biomarkers: androgen expression signaling and survival escape pathway signaling [ Time Frame: Up to 3 years ]Marker Evaluable Set (MES) where the MES will consist of all patients with baseline and Week 9 laboratory results derived from bone marrow samples. The number of patients with evaluable results may differ for each laboratory parameter. The MES will be used to assess the effect of treatment with apalutamide on androgen signaling and expression of survival/escape pathways in the bone marrow.
- Primary Analysis Set (PAS) [ Time Frame: Up to 3 years ]The PAS will consist of all patients who received at least one dose of any drug of the study combination treatment. This set will be used for all survival endpoints as well as safety. PSA will be measured at each time point according to the assessment schedule.
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): NCT03360721
|Contact: Eleni Efstathiou, MDfirstname.lastname@example.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Study Chair:||Eleni Efstathiou, MD||UT MD Anderson Cancer Center|