Page 12 - Delaware Medical Journal - September 2016
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CANCER CLINICAL TRIAL
NCI PROTOCOL OF THE MONTH
Alliance A031201: Phase III Trial of Enzalutamide (NSC # 766085) Versus Enzalutamide, Abiraterone and
Prednisone for Castration Resistant Metastatic Prostate Cancer
Objectives: To compare the overall survival of patients with progressive metastatic CRPC treated with either a) enzalutamide only or b) enzalutamide
with abiraterone and prednisone .
Secondary Objectives:
To assess and compare post-treatment PSA declines by treatment arm.
treatment.
To test for rPFS treatment interaction in predicting overall survival.
To assess pre- and post-treatment measures of tumor burden and bone activity using NaF PET/CT and Tc MDP bone scintigraphy and correlate
these measures with overall survival.
Correlative Study Objectives:
are predictive factors of overall survival.
To test whether the microRNA are predictive factors for overall survival.
To investigate a drug by CYP17A1 interaction with respect to overall survival.
other eQTLs.
combination.
enzalutamide combined with abiraterone in prostate cancer patients.
intrinsic and extrinsic factors.
combined with enzalutamide
alone and abiraterone plus enzalutamide.
Eligibilty:
3. Bone disease progression with two or more new lesions on bone scan
Treatment:
Patients are randomized to either ARM A or B. Treatment continues until disease progression or unacceptable toxicity.
ARM A: Vs
ARM B:
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
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