Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03360721|
Recruitment Status : Suspended (PI Request)
First Posted : December 4, 2017
Last Update Posted : April 29, 2022
|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. Cycles 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, 2022|
|Estimated Study Completion Date :||October 31, 2022|
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. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Abiraterone Acetate
- Progression free survival (PFS) [ Time Frame: From enrollment until radiographic progression, death from any cause, start of other therapy or last follow-up without progression, whichever comes first assessed up to 28 months ]Will be assessed using primary analysis set (PAS). Kaplan-Meier curves will be presented.
- Incidence of adverse events [ Time Frame: Up to 28 months ]Will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 with grade and attribution to study drug.
- Composite progression free survival (PFSc) [ Time Frame: From protocol treatment start until Prostate Cancer Working Group 2 (PCWG2) progression (radiographic progression, PSA progression, or clinical deterioration), death, starting new treatment or last follow-up without PCWG2 progression ]Will be assessed using PAS.
- Overall survival (OS) [ Time Frame: Baseline until death or last contact, assessed up to 28 months ]Will be assessed using PAS.
- Androgen expression signaling [ Time Frame: Baseline to week 13 ]Will be assessed using marker evaluable set (MES). The association between the biomarker and PSA level will be estimated using Spearman's rank correlation.
- Survival escape pathway signaling [ Time Frame: Baseline to week 13 ]Will be assessed using MES.
- PSA measurement [ Time Frame: Up to 28 months ]
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
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bagi Jana, MD||M.D. Anderson Cancer Center|