# COU-AA-301: abiraterone and increased survival in metastatic castration-resistant prostate cancer after docetaxel

Source: https://onco.cc/key-papers/paper-cou-aa-301-abiraterone-de-bono-nejm-2011/  
OnCo record `paper-cou-aa-301-abiraterone-de-bono-nejm-2011` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Abiraterone, a pill that blocks androgen synthesis throughout the body, lengthened survival in men with metastatic prostate cancer that had progressed after docetaxel, proving that the disease remains hormone-driven even when castration-resistant.

## Summary

Phase 3 placebo-controlled trial of 1,195 men with metastatic castration-resistant prostate cancer previously treated with docetaxel randomised 2:1 to abiraterone plus prednisone or placebo plus prednisone.

Median overall survival was 14.8 versus 10.9 months (hazard ratio 0.65), with improvements in PSA response, radiographic progression and pain; mineralocorticoid excess (fluid retention, hypokalaemia, hypertension) was the characteristic toxicity.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2011
- DOI: 10.1056/NEJMoa1014618
- Authors: de Bono JS, Logothetis CJ, Molina A, et al.
- Findings: Median overall survival 14.8 vs 10.9 months; hazard ratio 0.65.; PSA response 29 percent vs 6 percent.
- What it means: Abiraterone became a standard treatment for metastatic castration-resistant prostate cancer and, after later trials, for hormone-sensitive and high-risk localised disease.
- Caveats: Requires concurrent prednisone.; Cross-resistance with enzalutamide limits sequential use.

## Sources

- N Engl J Med 2011: https://doi.org/10.1056/NEJMoa1014618
- PubMed: https://pubmed.ncbi.nlm.nih.gov/21612468/

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

---
JSON: https://onco.cc/api/v1/entities/paper-cou-aa-301-abiraterone-de-bono-nejm-2011.json