招募中 NCT07568236

Fezolinetant 用於接受雄激素剝奪治療(ADT)男性血管舒縮症狀的試驗

前列腺癌Phase IIIII 期IV 期EGFR

這是一項隨機、雙盲、安慰劑對照、平行組、多中心臨床研究,旨在探討 fezolinetant 在接受 ADT 治療前列腺癌的男性中緩解血管舒縮綜合症的療效。

適應症:Vasomotor Symptoms、Prostate Cancer

收案條件

納入條件

  • 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

排除條件

  • 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)

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。