Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy
Open accessAbstract
BACKGROUND: Abiraterone acetate, an androgen biosynthesis inhibitor, improves overall survival in patients with metastatic castration-resistant prostate cancer after chemotherapy. We evaluated this agent in patients who had not received previous chemotherapy. METHODS: In this double-blind study, we randomly assigned 1088 patients to receive abiraterone acetate (1000 mg) plus prednisone (5 mg twice daily) or placebo plus prednisone. The coprimary end points were radiographic progression-free survival and overall survival. RESULTS: The study was unblinded after a planned interim analysis that was performed after 43% of the expected deaths had occurred. The median radiographic progression-free survival was 16.5 months with abiraterone-prednisone and 8.3 months with prednisone alone (hazard ratio for abiraterone-prednisone vs. prednisone alone, 0.53; 95% confidence interval [CI], 0.45 to 0.62; P<0.001). Over a median follow-up period of 22.2 months, overall survival was improved with abiraterone-prednisone (median not reached, vs. 27.2 months for prednisone alone; hazard ratio, 0.75; 95% CI, 0.61 to 0.93; P=0.01) but did not cross the efficacy boundary. Abiraterone-prednisone showed superiority over prednisone alone with respect to time to initiation of cytotoxic chemotherapy, opiate use for cancer-related pain, prostate-specific antigen progression, and decline in performance status. Grade 3 or 4 mineralocorticoid-related adverse events and abnormalities on liver-function testing were more common with abiraterone-prednisone. CONCLUSIONS: Abiraterone improved radiographic progression-free survival, showed a trend toward improved overall survival, and significantly delayed clinical decline and initiation of chemotherapy in patients with metastatic castration-resistant prostate cancer. (Funded by Janssen Research and Development, formerly Cougar Biotechnology; ClinicalTrials.gov number, NCT00887198.).
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Multiple phase 3 clinical trials have demonstrated the benefit of AR-targeted therapies on patient survival.
“Multiple phase 3 clinical trials have demonstrated the benefit of AR-targeted therapies on patient survival9–18.”
From Genome-scale CRISPR screens identify PTGES3 as a direct modulator of androgen receptor function in advanced prostate cancer (2025) · cites this paper as [11]
The Results (Efficacy; page unavailable) report fewer deaths with abiraterone than with prednisone in this phase 3 trial and a strong trend toward improved overall survival. But the interim analysis did not meet its prespecified significance boundary, so this paper does not establish the survival benefit as firmly as “demonstrated” implies. It is also one trial, not evidence by itself for multiple trials or AR-targeted therapies generally. (LLM, conf=0.88)
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- Authors
- Ryan, C. J., Smith, M. R., de Bono, J. S., Molina, A., Logothetis, C. J., de Souza, P., Fizazi, K., Mainwaring, P., Piulats, J. M., Ng, S., Carles, J., Mulders, P. F. A., Basch, E., Small, E. J., Saad, F., Schrijvers, D., Van Poppel, H., Mukherjee, S. D., Suttmann, H., Gerritsen, W. R., Flaig, T. W., George, D. J., Yu, E. Y., Efstathiou, E., Pantuck, A., Winquist, E., Higano, C. S., Taplin, M.-E., Park, Y., Kheoh, T., Griffin, T., Scher, H. I., & Rathkopf, D. E.
- Affiliations
- University of California, San Francisco (US)
- Massachusetts General Hospital (US)
- Janssen (Belgium) (BE)
- The University of Texas MD Anderson Cancer Center (US)
- Université Paris-Sud (FR)
- Institut Català d'Oncologia (ES)
- St John of God Subiaco Hospital (AU)
- Vall d'Hebron Hospital Universitari (ES)
- Radboud University Medical Center (NL)
- Memorial Sloan Kettering Cancer Center (US)
- Juravinski Cancer Centre (CA)
- Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
- University of Colorado Cancer Center (US)
- Duke Medical Center (US)
- University of Washington (US)
- University of California System (US)
- London Health Sciences Centre (CA)
- Dana-Farber Cancer Institute (US)
- ORCID
- Ryan, Charles J.
- Smith, Matthew R.
- Molina, Arturo
- Logothetis, Christopher J.
- Fizazi, Karim
- Mainwaring, Paul
- Piulats, Josep M.
- Carles, Joan
- Mulders, Peter F.A.
- Basch, Ethan
- Small, Eric J.
- Schrijvers, Dirk
- Gerritsen, Winald R.
- Flaig, Thomas W.
- George, Daniel J.
- Yu, Evan Y.
- Efstathiou, Eleni
- Winquist, Eric
- Higano, Celestia S.
- Taplin, Mary-Ellen
- Kheoh, Thian
- Scher, Howard I.
- Rathkopf, Dana E.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2013-01-10
- Volume
- 368
- Issue
- 2
- Pages
- 138-148
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC3683570
- OpenAlex
- W2137467802
- Cited by
- 2,796
- References
- 28
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- FWCI
- 186.27
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- other-oa
- Locations
- New England Journal of Medicine (publishedVersion, other-oa)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion, other-oa)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- UNC Libraries
- Funders
- National Institutes of Health (5k24ca121990-07)
- National Cancer Institute (K24-CA121990, P30CA008748, P30CA016672)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Keywords
- abiraterone, metastatic castration-resistant prostate cancer, androgen biosynthesis inhibitors, prednisone, progression-free survival, overall survival, liver dysfunction, prostate-specific antigen progression, cancer pain, performance status, chemotherapy delay
- MeSH terms
- Abiraterone Acetate, Androstadienes, Antineoplastic Combined Chemotherapy Protocols, Double-Blind Method, Humans, Male, Neoplasm Metastasis, Prednisone, Prostatic Neoplasms, Survival Analysis, Disease-Free Survival, Antineoplastic Agents, Hormonal
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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