A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
Summary
The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.
Timeline
- Start
- 2011-03-22
- Primary completion
- 2014-10-19
- Completion
- 2017-11-08
Outcome
Met primary endpoint
registry analysis (unspecified test); Enzalutamide vs Bicalutamide; p <0.0001; Hazard Ratio (HR) 0.44 (95% CI 0.34 to 0.57); Log Rank NCT01288911 ↗
paper Patients in the enzalutamide group had significantly improved median progression-free survival (15·7 months [95% CI 11·5-19·4]) compared with patients PMID 26774508 ↗
release “ENZALUTAMIDE PHASE 2 TERRAIN TRIAL DEMONSTRATED STATISTICALLY SIGNIFICANT INCREASE IN PFS” astellas.com ↗
Publications
- Schultz NM, Shore ND, Chowdhury S, Klotz LH, Concepcion RS, Penson DF, Karsh LI, Yang H, Brown BA, Barlev A, Flanders SC. Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials. BMC Urol. 2018 Sep 6;18(1):77. doi: 10.1186/s12894-018-0387-7.
- Heidenreich A, Chowdhury S, Klotz L, Siemens DR, Villers A, Ivanescu C, Holmstrom S, Baron B, Wang F, Lin P, Shore ND. Impact of Enzalutamide Compared with Bicalutamide on Quality of Life in Men with Metastatic Castration-resistant Prostate Cancer: Additional Analyses from the TERRAIN Randomised Clinical Trial. Eur Urol. 2017 Apr;71(4):534-542. doi: 10.1016/j.eururo.2016.07.027. Epub 2016 Aug 3.
- Shore ND, Chowdhury S, Villers A, Klotz L, Siemens DR, Phung D, van Os S, Hasabou N, Wang F, Bhattacharya S, Heidenreich A. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): a randomised, double-blind, phase 2 study. Lancet Oncol. 2016 Feb;17(2):153-163. doi: 10.1016/S1470-2045(15)00518-5. Epub 2016 Jan 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bicalutamide | Other / unclassified | 50 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |