这是一项随机、双盲、安慰剂对照、平行组、多中心临床研究，旨在探讨 fezolinetant 在接受 ADT 治疗前列腺癌的男性中缓解血管舒缩综合症的疗效。
适应症：Vasomotor Symptoms、Prostate Cancer
入组条件
纳入标准
- Patients aged at least 18 years old on the index date
- Histologically confirmed prostatic adenocarcinoma with localised or metastatic disease
- Karnofsky index score of 70% or more
- Started on androgen deprivation therapy (both medical or surgical), for at least 3 months at baseline
- Baseline daily hot flush score ≥4
排除标准
- Patients treated with drugs related to the study medications or with potential effect for vasomotor symptoms, including selective serotonin-re-uptake inhibitors, steroid hormones, clonidine, gabapentin, veralipride, or β-alanine
- Concomitant use of CYP1A2 inhibitors, e.g. fluoroquinolone, fluovoxamine, cimetidine, propranolol, verapamil, acyclovir, allopurinol, theophylline, etc.
- Active liver disease including:
- \- cirrhosis - liver failure - jaundice - elevated total or direct bilirubin - abnormal ALT / AST - abnormal INR
- Severe (eGFR 15 to less than 30 mL/min/1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL/min/1.73 m2)
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。