Phase II Trial of Abiraterone Acetate Combined With Dutasteride With Correlative Assessment of Tumor Androgen Levels and Androgen Receptor Sequence and Signaling at Baseline and at Progression
Patients will receive abiraterone acetate and prednisone orally, once daily for 2 months (2
cycles) on an outpatient basis. At the start of cycle 3, dutasteride will be taken once
daily. Patients will return to the clinic on Day 14 of the first 3 cycles for routine blood
Patients will come to the clinic every 12 weeks for a CT scan and/or x-ray of the chest, CT
scan or MRI of the abdomen and pelvis, bone scan, and blood test for testosterone and other
specialized blood test.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To analyze possible AR related mechanisms of abiraterone acetate resistance in serial CRPC metastasis biopsies.
To analyze possible AR related mechanisms of abiraterone acetate resistance in serial CRPC metastasis biopsies (including AR sequence-mutations/splice variants, AR regulated gene expression, tumor androgen levels and profiling enzymes involved in androgen synthesis and metabolism).
Mary-Ellen Taplin, M.D.
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|University of Washington Medical Center||Seattle, Washington 98195-6043|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|