本研究旨在評估 enzalutamide 於非轉移性前列腺癌患者的安全性與療效。
適應症：Nonmetastatic Castration-Resistant Prostate Cancer、Prostate Cancer、Cancer of the Prostate
收案條件
納入條件
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
- Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
- Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
- Progressive disease on androgen deprivation therapy at enrollment;
- PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
- PSA doubling time ≤ 10 months;
- No prior or present evidence of metastatic disease;
- Asymptomatic prostate cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Estimated life expectancy ≥ 12 months.
排除條件
- Prior cytotoxic chemotherapy;
- Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
- Known or suspected brain metastasis or active leptomeningeal disease;
- History of another invasive cancer within 3 years of randomization;
- Absolute neutrophil count \< 1000/μL, platelet count \< 100,000/μL, or hemoglobin \< 10 g/dL (6.2 mmol/L) at screening;
- Total bilirubin ≥ 1.5 times the upper limit of normal;
- Creatinine \> 2 mg/dL (177 µmol/L) at screening;
- Albumin \< 3.0 g/dL (30 g/L) at screening;
- History of seizure or any condition that may predispose to seizure;
- Clinically significant cardiovascular disease;
- Gastrointestinal disorder affecting absorption;
- Major surgery within 4 weeks of randomization;
- Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
- Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。