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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000018964 | Registry Identifier | UMIN-CTR |
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| Name | Class |
|---|---|
| Kagawa University | OTHER |
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The purpose of this study is to investigate the efficacy and safety of enzalutamide in patients with non-metastatic castration resistant prostate cancer. The total duration of the study will be 5 years. All patients will receive enzalutamide 160 mg (four 40 mg capsules) orally once daily. The treatment will be started at Visit 0 within one week after enrollment. Visit 1 is at 2 weeks after the treatment started; clinical assessments are conducted on adverse events and the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the investigator can continue the treatment with 12-week cycle visit (counted from initial dose) until patients meet withdrawal criteria. Patients will be followed up at 2 and 3 years after enrollment and at 3 years after the last participant enrollment. The end of the study is defined as follow-up assessment date at 3 years after the last participant enrollment. Patients will primarily be assessed by prostate-specific antigen (PSA) progression-free survival (PFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | All patients will receive enzalutamide 160 mg (four 40 mg capsules) orally once daily. The treatment will be started at Visit 0 within one week after enrollment. Visit 1 is at 2 weeks after the treatment started; clinical assessments are conducted on adverse events and the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the investigator can continue the treatment with 12-week cycle visit (counted from initial dose) until patients meet withdrawal criteria. Patients will be followed up at 2 and 3 years after enrollment and at 3 years after the last participant enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| PSA-progression-free survival (PSA-PFS) | Prostate specific antigen (PSA) progression-free survival is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of >= 25% and >= 2 ng/ml above the nadir after initial dose) or date of death from any cause, whichever comes first. | 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is defined as time from date of initial dose until date of death from any cause. | 6 years |
| Progression-free survival (PFS) | PFS is defined as time from date of initial dose until the date of first confirmed progression or date of death from any cause, whichever comes first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikio Sugimoto, MD, Ph.D. | Kagawa University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kagawa University Faculty of Medicine | Kita-gun | Kagawa-ken | 761-0793 | Japan | ||
| University of Miyazaki Faculty of Medicine |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
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| 6 years |
| Metastasis free survival (MFS) | MFS is defined as time from date of initial dose until the date of first metastasis which confirmed by computed tomography (CT) and bone scintigraphy. | 6 years |
| Time-to-PSA-progression (TTPP) | TTPP is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of >= 25% and >= 2 ng/ml above the nadir after initial dose). | 6 years |
| PSA response rate | PSA response rate is defined as ratio of patients who have an decrease in PSA of >= 50% above baseline, compared to PSA levels at week 2, every 12 weeks for up to 5 years after initial dose. | At week 2, and every 12 weeks for up to 6 years after initial dose |
| Time to first use of chemotherapy (TFC) | TFC is defined as time from date of initial dose until the date of first additional chemotherapy started for prostate cancer. | 6 years |
| QOL assessment using Japanese version of the FACT-P scales | Quality of life (QOL) is assessed on both total scores and each domain scores using Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales at baseline, week 2, week 60, withdrawal of treatment and at the end of treatment for up to 5 years. | Baseline, week 2, week 60, at withdrawal of treatment and at end of treatment for up to 6 years |
| Medication adherence (dosage) | Medication adherence is assessed in dosage of enzalutamide. | 6 years |
| Medication adherence (duration) | Medication adherence is assessed in duration of enzalutamide. | 6 years |
| Medication adherence (ratio) | Medication adherence is assessed in dosage rate of enzalutamide which is classfied into 3 categories: 1) >=80%, 2) >= 50% to < 80%, and 3) < 50%. | 6 years |
| Safety assessment on the incidence and severity of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | 6 years |
| Miyazaki |
| Miyazaki |
| 889-1692 |
| Japan |
| Tokyo Medical Center | Meguro-ku | Tokyo | 152-8902 | Japan |
| The Jikei university school of medicin | Minato-ku | Tokyo | 105-8461 | Japan |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |