Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03360721|
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : May 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Castration-Resistant Prostate Carcinoma Prostate Adenocarcinoma Without Neuroendocrine Differentiation Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8||Drug: Abiraterone Acetate Drug: Apalutamide Drug: Prednisone||Phase 2|
I. To assess the radiographic progression free survival (PFS) of men with metastatic castration resistant prostate cancer (mCRPC) who are selected for treatment based on positive biomarker signature.
I. Safety. II. Composite progression free survival (PFSc) defined by Prostate Cancer Working Group 2 (PCWG2) (radiographic progression, prostate specific antigen [PSA] progression, or clinical deterioration).
III. Overall survival. IV. Exploratory biomarker analyses. V. Measures of prostate specific antigen (PSA) decline and associations with outcome.
VI. Radiologic response by PCWG2 criteria. VII. Measures of circulating tumor cell (CTC) and conversion to undetectable and/or favorable < 5.
Participants receive abiraterone acetate orally (PO) once daily (QD), apalutamide PO QD, and prednisone PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up for up to 16 months.
|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 Metastatic Prostate Cancer Patients Evaluating a Predetermined Biomarker Signature|
|Actual Study Start Date :||March 6, 2018|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||October 31, 2020|
Experimental: Treatment (abiraterone acetate, apalutamide, prednisone)
Participants receive abiraterone acetate PO once daily QD, apalutamide PO QD, and prednisone PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Abiraterone Acetate
- 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, MDemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Eleni Efstathiou 713-563-0894 firstname.lastname@example.org|
|Principal Investigator: Eleni Efstathiou|
|Principal Investigator:||Eleni Efstathiou||M.D. Anderson Cancer Center|