drugset / Trial / NCT01664923
Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
Phase 2
Completed
396 enrolled
Pfizer
Astellas Pharma Inc · collabMedivation LLC, a wholly owned subsidiary of Pfizer Inc. · collab
RandomizedParallel-groupTriple-blindTreatment
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
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 |