Clinical Trials

Subject: Final analysis of Phase 3 trial confirming that abiraterone acetate prolongs OS  in patients who have progressed after docetaxel treatment

The Lancet has posted a final analysis from a Phase 3 study (sponsored by Janssen) before crossover from placebo to abiraterone acetate among patients with metastatic castration-resistant prostate cancer who progressed on docetaxel. Abiraterone had previously been shown to improve OS at a preplanned interim analysis.

Patients were randomly assigned (ratio 2:1) to receive either abiraterone acetate (1000 mg, once daily and orally) plus prednisone (5 mg, orally twice daily) or placebo plus prednisone. The final analysis confirms that abiraterone acetate “significantly prolongs overall survival” in patients who have progressed after docetaxel treatment. No new safety signals were identified with increased follow-up. 

At a median follow-up of 20.2 months, median OS for the abiraterone group was 15·8 months vs. 11·2 months in the placebo group.