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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide | Experimental | Enzalutamide 160 mg administered orally once a day as four 40-mg soft capsules |
|
| Flutamide | Active Comparator | Flutamide 125 mg administered orally three times a day as one tablet after meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug |
| ||
| Flutamide |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3 | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants whose PSA decreased 50 percent or more at month 6 | Month 6 | |
| Percentage of participants who showed disease progression at month 3 | Month 3 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka City University Graduate School of Medicine | Osaka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30971225 | 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. | |
| 31564004 |
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|
| Percentage of participants who showed disease progression at month 6 |
| Month 6 |
| PSA progression-free survival (PFS) | Up to 39 months |
| QOL measured by functional assessment of cancer therapy-prostate (FACT-P) | Up to 39 months |
| 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. |
| ID | Term |
|---|---|
| C540278 | enzalutamide |
| D005485 | Flutamide |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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