drugset / Trial / NCT02346578
Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy.
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC after treatment with Bic-CAB will be investigated.
Timeline
- Start
- 2014-12
- Primary completion
- 2018-09-30
- Completion
- 2019-01-22
Publications
- Background Iguchi T, Tamada S, Kato M, Yasuda S, Yamasaki T, Nakatani T. Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: study protocol for a multicenter randomized phase II trial (the OCUU-CRPC study). BMC Cancer. 2019 Apr 11;19(1):339. doi: 10.1186/s12885-019-5526-3.
- Results Iguchi T, Tamada S, Kato M, Yasuda S, Machida Y, Ohmachi T, Ishii K, Iwata H, Yamamoto S, Kanamaru T, Morimoto K, Hase T, Tashiro K, Harimoto K, Deguchi T, Adachi T, Iwamoto K, Takegaki Y, Nakatani T. Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: the OCUU-CRPC study. Int J Clin Oncol. 2020 Mar;25(3):486-494. doi: 10.1007/s10147-019-01554-3. Epub 2019 Sep 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Comparator | flutamide | Small molecule | 125 mg | Oral |