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Ther Adv Med Oncol. 2017 May;9(5):319-333. doi: 10.1177/1758834017698644. Epub 2017 Mar 22.

Abiraterone acetate and prednisone in chemotherapy-naïve prostate cancer patients: rationale, evidence and clinical utility.

Author information

Professor of Surgery/Urology/Radiation Oncology, Head Urologic Oncology, University of Colorado, Denver, Mail Stop #F 710, PO Box #6510, Aurora, CO 80045, USA.
Carolina Urologic Research Center, Myrtle Beach, SC, USA.
Smilow Cancer Center, Yale University, New Haven, CT, USA.
University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.


Abiraterone acetate 1000 mg/day, combined with prednisone 5 mg PO twice daily, is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Abiraterone acetate is the oral prodrug of abiraterone, a specific CYP17 inhibitor that blocks androgen biosynthesis within the adrenal glands, testes and tumor microenvironment. In a phase III trial of men with asymptomatic or minimally symptomatic, chemotherapy-naïve mCRPC, treatment with oral abiraterone acetate plus prednisone led to a statistically significant improvement in the co-primary endpoints of overall survival and radiographic progression-free survival when compared with placebo plus prednisone. In long-term follow-up of phase III trials, the incidence of corticosteroid-associated adverse events was 25.5% in the abiraterone acetate plus prednisone arm compared with 23.3% in the placebo plus prednisone arm. The need for regular patient monitoring and appropriate management of symptoms during long-term use of prednisone must be placed in context with the improvement in survival seen with abiraterone plus prednisone. Within the multidisciplinary environment that is emerging to meet quality and cost imperatives, abiraterone acetate plus prednisone is suitable for use in the chemotherapy-naïve population with minimal symptoms as well as in patients who have been treated with docetaxel and may have symptomatic disease. Ongoing trials are evaluating the role of abiraterone acetate plus prednisone in patients with nonmetastatic CRPC and metastatic hormone-sensitive prostate cancer, while further trials in the mCRPC setting are evaluating its use in combination regimens.


abiraterone acetate; chemotherapy-naïve; prednisone; prostate cancer

Conflict of interest statement

Conflict of interest statement: E. David Crawford is a consultant/adviser to Bayer, MDx, Genomic Health, Janssen Pharmaceuticals, Dendreon and Ferring, and has received grant support from NIH and the University of Colorado Cancer Center. His spouse is an employee at Dendreon. Neal D. Shore is a consultant/adviser to Amgen, Astellas, Bayer, BNI, Dendreon, Ferring, Janssen Pharmaceuticals, Medivation, Sanofi, Takeda and Tolmar. Daniel P. Petrylak is a consultant/adviser to Bayer, Bellicum, Dendreon, Sanofi, Johnson & Johnson, Exelixis, Ferring, Millennium, Medivation, Pfizer, Roche Laboratories, and Tyme Pharma-ceuticals, has received research funding from, Oncogenix, Progenics, Johnson & Johnson, Merck, Millennium, Dendreon, Sanofi, Agenysis, Eli Lilly, and Roche Laboratories and has ownership interest/investment in Bellicum and Tyme. Celestia S. Higano is an adviser for AbbVie, Bayer, BHR Pharma, Dendreon, Emergent BioSolutions, Ferring, Genentech, Medivation, Orion Corporation, Pfizer, Sanofi, MorphoSys, Churchill Pharmaceuticals, Astellas Pharma, Clovis Oncology, PAREXEL International, Blue Earth Diagnostics and Asana Biosciences; and has received institutional research funding from Algeta/Bayer, Aragon Pharmaceuti-cals, AstraZeneca, Dendreon, Emergent BioSolutions, Exelixis, Genentech, Medivation, Millennium, Oncogenex, Sanofi, Teva, Pfizer, Hoffman LaRoche, Gilead Sciences and Janssen Pharmaceuticals. Charles J. Ryan has received honoraria from Janssen Pharmaceuticals.

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