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RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer.
PURPOSE: This phase II trial is studying the side effects and how well giving abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer.
I. To evaluate the safety of abiraterone and prednisone with 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 GnRH agonist suppression of testicular androgens.
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 immunohistochemisty, cDNA microarray analysis and RT-PCR.
II. To evaluate time to PSA progression in patients treated with LHRH agonist with abiraterone acetate.
OUTLINE: Patients receive oral abiraterone acetate and oral prednisone once daily 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 every 3 months for 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
abiraterone acetate, prednisone, leuprolide acetate, mass spectrometry, laboratory biomarker analysis, immunohistochemistry staining method, microarray analysis, reverse transcriptase-polymerase chain reaction, external beam radiation therapy, goserelin
University of Miami Miller School of Medicine-Sylvester Cancer Center
Fred Hutchinson Cancer Research Center
Published on BioPortfolio: 2014-08-27T03:17:38-0400
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An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 184.108.40.206.
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