drugset / Trial / NCT02268175
Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate
RandomizedSingle-groupOpen-labelTreatment
Summary
This study is comparing the effectiveness of enzalutamide with or without abiraterone acetate for men with high-risk, localized prostate cancer.
Timeline
- Start
- 2014-10
- Primary completion
- 2018-01
- Completion
- 2021-12
Publications
- Lin HM, Yang X, Centenera MM, Huynh K, Giles C, Dehairs J, Swinnen JV, Hoy AJ, Meikle PJ, Butler LM, Taplin ME, Horvath LG. Circulating Lipid Profiles Associated With Resistance to Androgen Deprivation Therapy in Localized Prostate Cancer. JCO Precis Oncol. 2024 Jul;8:e2400260. doi: 10.1200/PO.24.00260.
- McKay RR, Ye H, Xie W, Lis R, Calagua C, Zhang Z, Trinh QD, Chang SL, Harshman LC, Ross AE, Pienta KJ, Lin DW, Ellis WJ, Montgomery B, Chang P, Wagner AA, Bubley GJ, Kibel AS, Taplin ME. Evaluation of Intense Androgen Deprivation Before Prostatectomy: A Randomized Phase II Trial of Enzalutamide and Leuprolide With or Without Abiraterone. J Clin Oncol. 2019 Apr 10;37(11):923-931. doi: 10.1200/JCO.18.01777. Epub 2019 Feb 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Background | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Background | Leuprolide | Other / unclassified | 7.5 mg | Intramuscular |
| Background | Leuprolide | Other / unclassified | 22.5 mg | Intramuscular |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |