非転移性去勢抵抗性前立腺がん患者を対象とした日本の研究 - エンザルタミド

基本情報

NCT ID

NCT02588001

ステータス

完了

試験のフェーズ

該当なし

試験タイプ

介入

目標被験者数

60

治験依頼者名

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

概要

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).

対象疾患

介入

依頼者（Sponsor）

実施施設 (4)