Phase II Trial of Radiation With Androgen Deprivation (AbiRAD): Abiraterone Acetate, Prednisone and LHRH Agonist Prior to and Concurrent With Radiation Therapy
I. To evaluate the safety of abiraterone (abiraterone acetate) and prednisone with
luteinizing hormone-releasing hormone (LHRH) agonist given as neoadjuvant and concurrent
therapy with external beam radiation in patients with localized prostate cancer.
II. To determine whether pharmacologic suppression of the prostatic androgen axis by
inhibition of androgen production with abiraterone can decrease tissue androgen levels to
below those observed with gonadotropin-releasing hormone (GnRH) agonist suppression of
I. To determine whether treatment with abiraterone acetate with LHRH agonist will be more
effective than LHRH agonist with bicalutamide in inducing inhibition of androgen-regulated
gene expression and increased apoptotic cell death as assessed by immunohistochemistry,
complementary deoxyribonucleic acid (cDNA) microarray analysis and reverse
transcription-polymerase chain reaction (RT-PCR).
II. To evaluate time to prostate-specific antigen (PSA) progression in patients treated with
LHRH agonist with abiraterone acetate.
Patients receive abiraterone acetate orally (PO) and prednisone PO once daily (QD) for 24
weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients
undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of acute and chronic grade 3 or greater toxicity as evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0
The distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method.
Up to 24 months after initiation of radiation therapy
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|MultiCare Regional Cancer Center Auburn||Auburn, Washington 98002|