Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
Summary
The purpose of this study is to determine the safety and efficacy of enzalutamide vs bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.
Timeline
- Start
- 2012-08
- Primary completion
- 2015-02
- Completion
- 2018-01
Outcome
Met primary endpoint
paper Enzalutamide reduced the risk of progression or death by 76% compared with bicalutamide (hazard ratio [HR], 0.24; 95% CI, 0.18 to 0.32; P < .001). PMID 26811535 ↗
registry MEDIAN Enzalutamide: 19.4 (16.5 to NA) months MEDIAN Bicalutamide: 5.7 (5.6 to 8.1) months NCT01664923 ↗
registry analysis (superiority or other test); Enzalutamide vs Bicalutamide; p <0.0001; Hazard Ratio (HR) 0.240 (95% CI 0.181 to 0.320); Log Rank; NCT01664923 ↗
release “ENZALUTAMIDE DEMONSTRATES STATISTICALLY SIGNIFICANT IMPROVEMENT IN PROGRESSION FREE SURVIVAL COMPARED WITH BICALUTAMIDE IN STRIVE TRIAL” astellas.com ↗
Publications
- Penson DF, Armstrong AJ, Concepcion RS, Agarwal N, Olsson CA, Karsh LI, Dunshee CJ, Duggan W, Shen Q, Sugg J, Haas GP, Higano CS. Enzalutamide versus bicalutamide in patients with nonmetastatic castration-resistant prostate cancer: a prespecified subgroup analysis of the STRIVE trial. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):363-365. doi: 10.1038/s41391-021-00465-7. Epub 2021 Oct 7.
- 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.
- Penson DF, Armstrong AJ, Concepcion R, Agarwal N, Olsson C, Karsh L, Dunshee C, Wang F, Wu K, Krivoshik A, Phung D, Higano CS. Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial. J Clin Oncol. 2016 Jun 20;34(18):2098-106. doi: 10.1200/JCO.2015.64.9285. Epub 2016 Jan 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bicalutamide | Other / unclassified | 50 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |