# Abiraterone in metastatic prostate cancer without previous chemotherapy

Source: https://onco.cc/key-papers/paper-abiraterone-acetate-prostate-n-engl-j-med-2013/  
OnCo record `paper-abiraterone-acetate-prostate-n-engl-j-med-2013` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Phase 2 or 3 results paper on Abiraterone acetate in Prostate cancer, in New England Journal of Medicine (2013), one of the most cited Europe PMC records with Abiraterone acetate in its title.

## Summary

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.).

Indexed on Europe PMC as PubMed record 23228172 (DOI 10.1056/nejmoa1209096). Its title names Abiraterone acetate and its text names Prostate cancer; PubMed types it as a clinical trial report (Research Support, Non-U.S. Gov't, research-article, Multicenter Study, Randomized Controlled Trial). It was matched automatically to the idea "Prescribe a quarter dose of abiraterone with breakfast" and no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: New England Journal of Medicine
- Year: 2013
- DOI: 10.1056/nejmoa1209096
- Authors: Ryan CJ, Smith MR, de Bono JS, et al.
- What it means: One of the most cited trial reports Europe PMC returns for Abiraterone acetate in Prostate cancer, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
- Caveats: Matched by Abiraterone acetate in the title and Prostate cancer in the title or abstract of the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; Chosen as a phase 2 or 3 report by the record's publication type or its own wording, not by reading the paper.

## Sources

- N Engl J Med 2013: https://doi.org/10.1056/nejmoa1209096
- PubMed: https://pubmed.ncbi.nlm.nih.gov/23228172/
- Europe PMC: https://europepmc.org/article/MED/23228172

## Connected records

- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)
- ideas: [Prescribe a quarter dose of abiraterone with breakfast](https://onco.cc/ideas/idea-cost-low-dose-abiraterone-food/)

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