# 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.
- Findings: Median radiographic progression-free survival 16.5 months with abiraterone and prednisone against 8.3 months with prednisone alone (hazard ratio 0.53; 95 percent confidence interval 0.45 to 0.62; P less than 0.001), in 1,088 chemotherapy-naive patients.; Over a median follow-up of 22.2 months, overall survival was improved with abiraterone and prednisone (median not reached against 27.2 months; hazard ratio 0.75; 0.61 to 0.93; P equals 0.01) but did not cross the pre-specified efficacy boundary.; Abiraterone and prednisone were superior for 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 liver-function abnormalities were more common with abiraterone and prednisone.
- 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

- roadmaps: [Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch](https://onco.cc/roadmaps/prostate-roadmap/)
- key papers: [COU-AA-301: abiraterone and increased survival in metastatic castration-resistant prostate cancer after docetaxel](https://onco.cc/key-papers/paper-cou-aa-301-abiraterone-de-bono-nejm-2011/), [Phase 1 trial of abiraterone acetate confirms that castration-resistant prostate cancer commonly remains hormone driven](https://onco.cc/key-papers/paper-attard-abiraterone-phase-1-cyp17-jco-2008/), [PREVAIL: enzalutamide in metastatic prostate cancer before chemotherapy](https://onco.cc/key-papers/paper-beer-prevail-enzalutamide-nejm-2014/)
- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- fronts: [Hormonal Therapy](https://onco.cc/fronts/hormonal/), [Targeted Therapy](https://onco.cc/fronts/targeted-therapy/)
- targets: [Androgen receptor](https://onco.cc/targets/androgen-receptor/)
- drugs: [Abiraterone acetate](https://onco.cc/drugs/abiraterone/), [Prednisone](https://onco.cc/drugs/prednisone/)
- terms: [Castration-resistant prostate cancer (CRPC)](https://onco.cc/terms/castration-resistance/), [PSA (prostate-specific antigen)](https://onco.cc/terms/psa/), [Radiographic progression-free survival (rPFS)](https://onco.cc/terms/radiographic-progression-free-survival/)
- bottlenecks: [Acquired resistance to every therapy](https://onco.cc/bottlenecks/b-resistance/)
- 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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